Trial Outcomes & Findings for A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome (NCT NCT05856526)
NCT ID: NCT05856526
Last Updated: 2026-03-12
Results Overview
Proportion of participants with an Ichthyosis Area Severity Index (IASI) response at Week 16 is reported. IASI response was defined as a decrease of at least 50% absolute change in IASI score from baseline at Week 16. Proportions were rounded to 3 decimal places. IASI is a composite score based on the global Congenital Ichthyosis Severity Instrument (CISI) score that captures differences in severity in different body regions as a function of their body surface area, and also standardizes the number of choices within the Likert scales for erythema and scaling. The score ranges from 0-48 (sum of a max score of 24 for erythema and 24 for scaling). A higher score means worse clinical severity. 95% confidence intervals (CI) are calculated using the method of Wilson.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
43 participants
Primary outcome timeframe
At baseline and at Week 16.
Results posted on
2026-03-12
Participant Flow
This was a placebo-controlled trial to evaluate the efficacy and safety of spesolimab in the treatment of patients with Netherton syndrome.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Placebo
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
Randomised treatment period
STARTED
|
15
|
28
|
|
Randomised treatment period
COMPLETED
|
15
|
27
|
|
Randomised treatment period
NOT COMPLETED
|
0
|
1
|
|
Crossover treatment period
STARTED
|
15
|
27
|
|
Crossover treatment period
COMPLETED
|
13
|
20
|
|
Crossover treatment period
NOT COMPLETED
|
2
|
7
|
|
Open label treatment period
STARTED
|
13
|
20
|
|
Open label treatment period
COMPLETED
|
6
|
12
|
|
Open label treatment period
NOT COMPLETED
|
7
|
8
|
|
Extended treatment period
STARTED
|
6
|
12
|
|
Extended treatment period
COMPLETED
|
0
|
0
|
|
Extended treatment period
NOT COMPLETED
|
6
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
Randomised treatment period
Perceived lack of efficacy
|
0
|
1
|
|
Crossover treatment period
Other than listed
|
1
|
0
|
|
Crossover treatment period
Protocol Violation
|
0
|
1
|
|
Crossover treatment period
Perceived lack of efficacy
|
0
|
2
|
|
Crossover treatment period
Adverse Event
|
0
|
1
|
|
Crossover treatment period
Study terminated by sponsor
|
1
|
3
|
|
Open label treatment period
Other than listed
|
0
|
1
|
|
Open label treatment period
Protocol Violation
|
0
|
1
|
|
Open label treatment period
Burden of study procedure
|
1
|
0
|
|
Open label treatment period
Change of residence
|
1
|
0
|
|
Open label treatment period
Perceived lack of efficacy
|
2
|
1
|
|
Open label treatment period
Study terminated by sponsor
|
3
|
5
|
|
Extended treatment period
Perceived lack of efficacy
|
0
|
3
|
|
Extended treatment period
Study terminated by sponsor
|
6
|
9
|
Baseline Characteristics
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.7 Years
STANDARD_DEVIATION 12.6 • n=9 Participants
|
33.3 Years
STANDARD_DEVIATION 18.2 • n=9 Participants
|
31.7 Years
STANDARD_DEVIATION 16.5 • n=18 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
13 Participants
n=9 Participants
|
22 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
15 Participants
n=9 Participants
|
21 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
14 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=9 Participants
|
19 Participants
n=9 Participants
|
28 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
14 Participants
n=9 Participants
|
24 Participants
n=9 Participants
|
38 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
1 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
IASI score at baseline
|
25.07 score on a scale
STANDARD_DEVIATION 7.40 • n=9 Participants
|
25.05 score on a scale
STANDARD_DEVIATION 7.23 • n=9 Participants
|
25.06 score on a scale
STANDARD_DEVIATION 7.20 • n=18 Participants
|
PRIMARY outcome
Timeframe: At baseline and at Week 16.Population: FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=Imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome.
Proportion of participants with an Ichthyosis Area Severity Index (IASI) response at Week 16 is reported. IASI response was defined as a decrease of at least 50% absolute change in IASI score from baseline at Week 16. Proportions were rounded to 3 decimal places. IASI is a composite score based on the global Congenital Ichthyosis Severity Instrument (CISI) score that captures differences in severity in different body regions as a function of their body surface area, and also standardizes the number of choices within the Likert scales for erythema and scaling. The score ranges from 0-48 (sum of a max score of 24 for erythema and 24 for scaling). A higher score means worse clinical severity. 95% confidence intervals (CI) are calculated using the method of Wilson.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
IASI Response, Defined as a Decrease of at Least 50% Absolute Change in IASI Score From Baseline at Week 16 (Yes/No)
|
0.133 proportion of participants
Interval 0.037 to 0.379
|
0.286 proportion of participants
Interval 0.153 to 0.471
|
SECONDARY outcome
Timeframe: Baseline and at Week 16 after start of study treatment administration.Population: FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=Imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome.
Proportion of participants with an Investigator Global Assessment (IGA) response at Week 16 is reported. Proportions were rounded to 3 decimal places. IGA response was defined as a decrease of at least 1-grade absolute change in IGA score from baseline at Week 16. IGA for Netherton Syndrome (NS) assessed the global severity of erythema and scaling in NS using a 5-point Likert scale ranging from 0=clear, to 4=severe. 95% confidence intervals (CI) are calculated using the method of Wilson.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
Key Secondary Endpoint: IGA Response, Defined as a Decrease of at Least 1-grade Absolute Change in IGA Score From Baseline at Week 16 (Yes/No)
|
0.400 proportion of participants
Interval 0.198 to 0.643
|
0.357 proportion of participants
Interval 0.207 to 0.542
|
SECONDARY outcome
Timeframe: At Week 4, at Week 8, at Week 12, at Week 16 after start of study treatment administration.Population: FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=Imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome.
Proportion of participants with an Investigator Global Assessment (IGA) score of 0 or 1 at Week 4, at Week 8, at Week 12 and at Week 16 after first study treatment administration is reported. Proportions were rounded to 3 decimal places. IGA for Netherton Syndrome (NS) assessed the global severity of erythema and scaling in NS using a 5-point Likert scale ranging from 0=clear, to 4=severe. 95% confidence intervals (CI) are calculated using the method of Wilson.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
IGA Score of 0 or 1 at Weeks 4, 8, 12 and 16 (Yes/No)
Week 4
|
0.000 proportion of participants
Interval 0.0 to 0.204
|
0.036 proportion of participants
Interval 0.006 to 0.177
|
|
IGA Score of 0 or 1 at Weeks 4, 8, 12 and 16 (Yes/No)
Week 8
|
0.000 proportion of participants
Interval 0.0 to 0.204
|
0.000 proportion of participants
Interval 0.0 to 0.121
|
|
IGA Score of 0 or 1 at Weeks 4, 8, 12 and 16 (Yes/No)
Week 12
|
0.000 proportion of participants
Interval 0.0 to 0.204
|
0.036 proportion of participants
Interval 0.006 to 0.177
|
|
IGA Score of 0 or 1 at Weeks 4, 8, 12 and 16 (Yes/No)
Week 16
|
0.000 proportion of participants
Interval 0.0 to 0.204
|
0.036 proportion of participants
Interval 0.006 to 0.177
|
SECONDARY outcome
Timeframe: At baseline and at Week 4, at Week 8, at Week 12 after start of study treatment administration.Population: FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=Imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome.
Proportion of participants with an Ichthyosis Area Severity Index (IASI) response at Weeks 4, 8, 12 is reported. Proportions were rounded to 3 decimal places. IASI response was defined as a decrease of at least 50% absolute change in IASI score from baseline at Week 4, Week 8 and Week 12. IASI is a composite score based on the global Congenital Ichthyosis Severity Instrument (CISI) score that captures differences in severity in different body regions as a function of their body surface area, and also standardizes the number of choices within the Likert scales for erythema and scaling. The score ranges from 0-48 (sum of a max score of 24 for erythema and 24 for scaling). A higher score means worse clinical severity. 95% confidence intervals (CI) are calculated using the method of Wilson.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
IASI Response, Defined as a Decrease of at Least 50% Absolute Change in IASI Score From Baseline at Weeks 4, 8, and 12 (Yes/No)
IASI response at Week 4
|
0.067 proportion of participants
Interval 0.012 to 0.298
|
0.250 proportion of participants
Interval 0.127 to 0.434
|
|
IASI Response, Defined as a Decrease of at Least 50% Absolute Change in IASI Score From Baseline at Weeks 4, 8, and 12 (Yes/No)
IASI response at Week 8
|
0.067 proportion of participants
Interval 0.012 to 0.298
|
0.286 proportion of participants
Interval 0.153 to 0.471
|
|
IASI Response, Defined as a Decrease of at Least 50% Absolute Change in IASI Score From Baseline at Weeks 4, 8, and 12 (Yes/No)
IASI response at Week 12
|
0.133 proportion of participants
Interval 0.037 to 0.379
|
0.286 proportion of participants
Interval 0.153 to 0.471
|
SECONDARY outcome
Timeframe: At baseline and at Week 4, at Week 8, at Week 12, at Week 16 after start of study treatment administration.Population: FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome.
Proportion of participants with an Ichthyosis Area Severity Index-Erythema (IASI-E) subscore response at Weeks 4, 8, 12 and 16 is reported. Proportions were rounded to 3 decimal places. IASI-E response was defined as a decrease of at least 50% absolute change in IASI-E subscore from baseline at Week 4, at Week 8, at Week 12 and at Week 16. IASI-E is a composite score based on the global Congenital Ichthyosis Severity Instrument (CISI) score that captures differences in severity in different body regions as a function of their body surface area, and also standardizes the number of choices within the Likert scales for erythema. The score ranges from 0-24. A higher score means worse clinical severity. 95% confidence intervals (CI) are calculated using the method of Wilson.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
IASI-E Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-E Subscore at Weeks 4, 8, 12, and 16 (Yes/No)
IASI-E subscore response at Week 4
|
0.000 proportion of participants
Interval 0.0 to 0.204
|
0.250 proportion of participants
Interval 0.127 to 0.434
|
|
IASI-E Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-E Subscore at Weeks 4, 8, 12, and 16 (Yes/No)
IASI-E subscore response at Week 8
|
0.133 proportion of participants
Interval 0.037 to 0.379
|
0.321 proportion of participants
Interval 0.179 to 0.507
|
|
IASI-E Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-E Subscore at Weeks 4, 8, 12, and 16 (Yes/No)
IASI-E subscore response at Week 12
|
0.133 proportion of participants
Interval 0.037 to 0.379
|
0.286 proportion of participants
Interval 0.153 to 0.471
|
|
IASI-E Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-E Subscore at Weeks 4, 8, 12, and 16 (Yes/No)
IASI-E subscore response at Week 16
|
0.133 proportion of participants
Interval 0.037 to 0.379
|
0.286 proportion of participants
Interval 0.153 to 0.471
|
SECONDARY outcome
Timeframe: At baseline and at Week 4, at Week 8, at Week 12, at Week 16 after start of study treatment administration.Population: FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome.
Proportion of participants with an Ichthyosis Area Severity Index-Scaling (IASI-S) subscore response at Weeks 4, 8, 12 and 16 is reported. Proportions were rounded to 3 decimal places. IASI-S response was defined as a decrease of at least 50% absolute change in IASI-S subscore from baseline at Week 4, at Week 8, at Week 12 and at Week 16. IASI-S is a composite score based on the global Congenital Ichthyosis Severity Instrument (CISI) score that captures differences in severity in different body regions as a function of their body surface area, and also standardizes the number of choices within the Likert scales for scaling. The score ranges from 0-24. A higher score means worse clinical severity. 95% confidence intervals (CI) are calculated using the method of Wilson.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
IASI-S Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-S Subscore From Baseline at Weeks 4, 8, 12, and 16 (Yes/No)
IASI-S subscore response at Week 4
|
0.067 proportion of participants
Interval 0.012 to 0.298
|
0.214 proportion of participants
Interval 0.102 to 0.395
|
|
IASI-S Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-S Subscore From Baseline at Weeks 4, 8, 12, and 16 (Yes/No)
IASI-S subscore response at Week 8
|
0.133 proportion of participants
Interval 0.037 to 0.379
|
0.286 proportion of participants
Interval 0.153 to 0.471
|
|
IASI-S Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-S Subscore From Baseline at Weeks 4, 8, 12, and 16 (Yes/No)
IASI-S subscore response at Week 12
|
0.133 proportion of participants
Interval 0.037 to 0.379
|
0.286 proportion of participants
Interval 0.153 to 0.471
|
|
IASI-S Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-S Subscore From Baseline at Weeks 4, 8, 12, and 16 (Yes/No)
IASI-S subscore response Week 16
|
0.200 proportion of participants
Interval 0.07 to 0.452
|
0.250 proportion of participants
Interval 0.127 to 0.434
|
SECONDARY outcome
Timeframe: MMRM model included measurements from baseline and Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 68 after study treatment administration. MMRM values of percent change from baseline at Week 4, 8, 12, 16 are presented.Population: FAS (EH-MMRM). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored.
Percent change from baseline in IASI score at Weeks 4, 8, 12 and 16 is reported. IASI is a composite score based on the global Congenital Ichthyosis Severity Instrument (CISI) score that captures differences in severity in different body regions as a function of their body surface area, and also standardizes the number of choices within the Likert scales for erythema and scaling. The score ranges from 0-48 (sum of a max score of 24 for erythema and 24 for scaling). A higher score means worse clinical severity. Percent change of IASI score= (IASI score at Week X - IASI score at baseline)\*100/(IASI score at baseline). Week X=4, 8, 12, 16. Least Squares Mean (95% Confidence Interval) were calculated using mixed effect model with repeated measures (MMRM) which included the fixed, categorical effects of treatment at each visit, age group and the continuous effect of baseline at each visit as well as random effects of subject.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
Percent Change From Baseline in IASI Score at Weeks 4, 8, 12 and 16
Percent change at Week 4
|
2.5 percent change
Interval -18.5 to 23.4
|
-22.4 percent change
Interval -38.0 to -6.8
|
|
Percent Change From Baseline in IASI Score at Weeks 4, 8, 12 and 16
Percent change at Week 8
|
-11.1 percent change
Interval -28.1 to 5.8
|
-30.4 percent change
Interval -43.1 to -17.8
|
|
Percent Change From Baseline in IASI Score at Weeks 4, 8, 12 and 16
Percent change at Week 12
|
-17.6 percent change
Interval -36.0 to 0.9
|
-27.3 percent change
Interval -41.0 to -13.6
|
|
Percent Change From Baseline in IASI Score at Weeks 4, 8, 12 and 16
Percent change at Week 16
|
-23.4 percent change
Interval -39.9 to -6.8
|
-34.3 percent change
Interval -47.1 to -21.5
|
SECONDARY outcome
Timeframe: MMRM model included measurements from baseline and Week 4, 8, 12, 16, 20, 24, 28, 32, 40, 52, 64 after study treatment administration. MMRM values of absolute change from baseline in NRS pain at Week 4, 8, 12, 16 are presented.Population: FAS (EH-MMRM). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored.
Absolute change from baseline in Numeric Pain Rating Scale (NRS) pain at Weeks 4, 8, 12 and 16 is presented. The NRS is a unidimensional measure of pain intensity, including chronic pain. The 11-point numeric scale ranges from '0' representing 'no pain' to '10' representing worst pain imaginable. Absolute change in NRS at Week X= (NRS pain at Week X) - (NRS pain at baseline). Week X= 4, 8, 12, 16. Least Squares Mean (95% Confidence Interval) were calculated using mixed effect model with repeated measures (MMRM) which included the fixed, categorical effects of treatment at each visit, age group and the continuous effect of baseline at each visit as well as random effects of subject.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
Absolute Change From Baseline in NRS Pain at Weeks 4, 8, 12 and 16
Absolute change at Week 12
|
0.2 units on a scale
Interval -0.9 to 1.2
|
-0.4 units on a scale
Interval -1.2 to 0.4
|
|
Absolute Change From Baseline in NRS Pain at Weeks 4, 8, 12 and 16
Absolute change at Week 4
|
-0.0 units on a scale
Interval -1.0 to 0.9
|
-0.5 units on a scale
Interval -1.2 to 0.2
|
|
Absolute Change From Baseline in NRS Pain at Weeks 4, 8, 12 and 16
Absolute change at Week 8
|
0.3 units on a scale
Interval -0.8 to 1.4
|
-0.4 units on a scale
Interval -1.2 to 0.5
|
|
Absolute Change From Baseline in NRS Pain at Weeks 4, 8, 12 and 16
Absolute change at Week 16
|
-0.2 units on a scale
Interval -1.2 to 0.8
|
-0.2 units on a scale
Interval -1.0 to 0.6
|
SECONDARY outcome
Timeframe: MMRM model included measurements from baseline and Week 4, 8, 12, 16, 20, 24, 28, 32, 40, 52, 64 after study treatment administration. MMRM values of absolute change from baseline in NRS itch at Week 4, 8, 12, 16 are presented.Population: FAS (EH-MMRM). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored.
The Numeric Pain Rating Scale (NRS) itch measures the intensity of itch. The scale ranges from '0' representing 'no itch' to 10 'worst imaginable itch'. Absolute change in NRS itch at Week X= (NRS itch at Week X) - (NRS itch at baseline). Week X= 4, 8, 12, 16. Least Squares Mean (95% Confidence Interval) were calculated using mixed effect model with repeated measures (MMRM) which included the fixed, categorical effects of treatment at each visit, age group and the continuous effect of baseline at each visit as well as random effects of subject.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
Absolute Change From Baseline in NRS Itch at Weeks 4, 8, 12 and 16
Absolute change at Week 4
|
-0.6 units on a scale
Interval -1.5 to 0.4
|
0.3 units on a scale
Interval -0.4 to 1.0
|
|
Absolute Change From Baseline in NRS Itch at Weeks 4, 8, 12 and 16
Absolute change at Week 8
|
-0.2 units on a scale
Interval -1.2 to 0.8
|
-0.3 units on a scale
Interval -1.1 to 0.5
|
|
Absolute Change From Baseline in NRS Itch at Weeks 4, 8, 12 and 16
Absolute change at Week 12
|
-0.5 units on a scale
Interval -1.6 to 0.6
|
-0.0 units on a scale
Interval -0.9 to 0.8
|
|
Absolute Change From Baseline in NRS Itch at Weeks 4, 8, 12 and 16
Absolute change at Week 16
|
-0.7 units on a scale
Interval -1.7 to 0.3
|
-0.6 units on a scale
Interval -1.4 to 0.1
|
SECONDARY outcome
Timeframe: MMRM model included measurements from baseline and Week 8, 16, 24, 32, 52, after study treatment administration. MMRM values of absolute change from baseline in DLQI score at Week 8, 16 are presented.Population: FAS (EH-MMRM). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored. Participants \>= 18 years and with a baseline DLQI score value are reported.
Dermatology Life Quality Index (DLQI) assesses various dermatologic conditions and it measures the quality of life. It contains 10 questions which are score from 0 (not relevant) to 3 (very much). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. Total score ranges from 0 to 30 in total. Scores of 0-1 indicate no effect, scores of 2-5 indicate a small effect, scores of 6-10 indicate moderate effect, score 11-20 indicate very large effect and scores 21-30 indicate an extremely large effect of the syndrome on the participant. Absolute change in DLQI score at Week X= (DLQI score at Week X) - (DLQI score at baseline). Week X= 8, 16. Least Squares Mean (95% Confidence Interval) were calculated using mixed effect model with repeated measures (MMRM) which included the fixed, categorical effects of treatment at each visit, age group and the continuous effect of baseline at each visit as well as random effects of subject.
Outcome measures
| Measure |
Placebo
n=13 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=21 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
Absolute Change From Baseline in DLQI Score at Weeks 8 and 16
Absolute change at Week 8
|
-0.5 units on a scale
Interval -2.4 to 1.4
|
-1.2 units on a scale
Interval -2.8 to 0.4
|
|
Absolute Change From Baseline in DLQI Score at Weeks 8 and 16
Absolute change at Week 16
|
-2.1 units on a scale
Interval -4.1 to 0.0
|
-1.2 units on a scale
Interval -3.0 to 0.7
|
SECONDARY outcome
Timeframe: At baseline and at Week 8 and at Week 16 after study treatment administration.Population: FAS (EH). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored. Only paediatric (\>= 12 to \< 18 years) participants with data available for the CDLQI score at Week 8 and at Week 16 are reported.
Children's Dermatology Life Quality Index (CDLQI) measures the impact of skin disease on the lives of children and young people. CDLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30. Scores of 0-1 indicate no effect, scores of 2-6 indicate a small effect, scores of 7-12 indicate moderate effect, score 13-18 indicate very large effect and scores 19-30 indicate an extremely large effect of the syndrome on the participant. Absolute change in CDLQI score at Week X= (CDLQI score at Week X) - (CDLQI score at baseline). Week X= 8, 16.
Outcome measures
| Measure |
Placebo
n=1 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=5 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
Absolute Change From Baseline in CDLQI Score at Weeks 8 and 16
Absolute change at Week 8
|
-1.00 units on a scale
Standard Deviation NA
NA=Not calculable. Standard deviation could not be calculated since N=1.
|
-1.20 units on a scale
Standard Deviation 3.96
|
|
Absolute Change From Baseline in CDLQI Score at Weeks 8 and 16
Absolute change at Week 16
|
3.00 units on a scale
Standard Deviation NA
NA=Not calculable. Standard deviation could not be calculated since N=1.
|
-2.40 units on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: From first study treatment administration until end of randomised period (Week 16) plus 16 weeks of residual effect period, up to 32 weeks.Population: Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial.
Percentage of patients with treatment emergent adverse events including serious and/or opportunistic infections is presented. Percentages are rounded to one decimal place.
Outcome measures
| Measure |
Placebo
n=15 Participants
Randomised period Participants received placebo matching spesolimab from Week 0 to Week 16.
Crossover period At Week 16 participants received Spesolimab at higher dose and placebo.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks.
Extended treatment Period Non-responding participants receiving medium dose of spesolimab were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
Spesolimab
n=28 Participants
Randomised period Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
Crossover period At Week 16 participants received placebo and a medium dose of spesolimab.
Open label period After cross-over period, participants entered the open label period to receive spesolimab at medium dose every 4 weeks. At Week 32, patients were evaluated for response to treatment. Responders received a low dose of spesolimab every 4 weeks, while non-responders continued receiving medium dose of spesolimab every 4 weeks until Week 52.
Extended treatment Period Non-responding participants were discontinued from the trial. Participants receiving low dose of spesolimab and experiencing a non-response were not to be discontinued, but up-titrated to medium dose first. Only if the patients still didn't show response to treatment, participants were discontinued.
|
|---|---|---|
|
The Occurrence of Treatment Emergent Adverse Events Including Serious and/or Opportunistic Infections
|
73.3 percentage of participants
|
71.4 percentage of participants
|
Adverse Events
Randomised Period: Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Randomised Period: Spesolimab
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Spesolimab Crossover Period
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Crossover Period
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Spesolimab Open Label
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomised Period: Placebo
n=15 participants at risk
Participants received placebo matching spesolimab from Week 0 to Week 16.
|
Randomised Period: Spesolimab
n=28 participants at risk
Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
|
Spesolimab Crossover Period
n=27 participants at risk
Participants who received spesolimab from Week 0 to Week 16, at Week 16 participants received placebo and a medium or low dose of spesolimab.
|
Placebo Crossover Period
n=15 participants at risk
Participants who received placebo from Week 0 to Week 16, at Week 16 participants received Spesolimab at higher dose and placebo.
|
Spesolimab Open Label
n=42 participants at risk
This arm includes all patients who were initially randomised to placebo or Spesolimab, who received from Week 20 of Crossover period to end of the Extended Treatment period either a medium dose of spesolimab or a low dose of spesolimab.
|
|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Netherton's syndrome
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
General disorders
Peripheral swelling
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.6%
1/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.6%
1/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Nasal vestibulitis
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.7%
1/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.6%
1/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
Other adverse events
| Measure |
Randomised Period: Placebo
n=15 participants at risk
Participants received placebo matching spesolimab from Week 0 to Week 16.
|
Randomised Period: Spesolimab
n=28 participants at risk
Participants received at Week 0 a high dose of spesolimab. Starting from Week 4 until Week 16 participants received every 4 weeks a medium dose of spesolimab.
|
Spesolimab Crossover Period
n=27 participants at risk
Participants who received spesolimab from Week 0 to Week 16, at Week 16 participants received placebo and a medium or low dose of spesolimab.
|
Placebo Crossover Period
n=15 participants at risk
Participants who received placebo from Week 0 to Week 16, at Week 16 participants received Spesolimab at higher dose and placebo.
|
Spesolimab Open Label
n=42 participants at risk
This arm includes all patients who were initially randomised to placebo or Spesolimab, who received from Week 20 of Crossover period to end of the Extended Treatment period either a medium dose of spesolimab or a low dose of spesolimab.
|
|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Netherton's syndrome
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
14.3%
4/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
16.7%
7/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
General disorders
Injection site erythema
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.6%
1/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Investigations
Lipase increased
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
General disorders
Injection site hypertrophy
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
General disorders
Injection site pain
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
7.1%
2/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
4.8%
2/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Immune system disorders
Food allergy
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
7.1%
3/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Cystitis
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Folliculitis
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.6%
1/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
4.8%
2/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Fungal skin infection
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
3/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
7.1%
2/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
11.9%
5/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Periodontitis
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Rhinitis
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Skin bacterial infection
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
14.3%
4/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
4.8%
2/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.6%
1/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.7%
1/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
7.1%
3/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Investigations
Amylase increased
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Investigations
Blood fibrinogen increased
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Investigations
Protein urine present
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
7.1%
2/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.6%
1/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
4.8%
2/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
4.8%
2/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
3.6%
1/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
7.1%
3/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
7.1%
2/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
2.4%
1/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
6.7%
1/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/28 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/27 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/15 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
0.00%
0/42 • "Randomised period: Placebo" and "Randomised period: Spesolimab": From treatment start until end of Week 16 + 16 weeks residual effect period (REP), up to 32 weeks. "Placebo crossover period" and "Spesolimab crossover period": From Week 16 to Week 20 + 16 weeks REP, up to 20 weeks. "Spesolimab open label": From Week 20 to end of study treatment administration at Week 78 of Extended Treatment period +16 weeks REP, up to 74 weeks.
Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. "Spesolimab open label" arm includes all patients who received open label spesolimab from Week 20 of the Crossover period until end of Extended Treatment Period.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER