Trial Outcomes & Findings for The Efficacy and Safety of Secukinumab in Patients With Ichthyoses (NCT NCT03041038)
NCT ID: NCT03041038
Last Updated: 2021-08-25
Results Overview
Primary Efficacy Endpoint. The IASI score was modelled after the Eczema Area and Severity Index (EASI) and Psoriasis Area and Severity Index (PASI), commonly used in clinical trials for atopic dermatitis and psoriasis, respectively. This scale measures erythema and scaling and has a range of 0-48 (sum of a max score of 24 for erythema and 24 for scaling). A higher score means worse clinical severity. Mean difference IASI total score at Baseline was compared to IASI total score at Week 16.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
16 Weeks
Results posted on
2021-08-25
Participant Flow
Participant milestones
| Measure |
Secukinumab
Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
Secukinumab: Anti IL-17A antibody
|
Placebo
Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
Week 16
|
10
|
8
|
|
Overall Study
Week 32
|
9
|
8
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Secukinumab
Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
Secukinumab: Anti IL-17A antibody
|
Placebo
Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
The Efficacy and Safety of Secukinumab in Patients With Ichthyoses
Baseline characteristics by cohort
| Measure |
Secukinumab
n=11 Participants
Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
Secukinumab: Anti IL-17A antibody
|
Placebo
n=9 Participants
Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
Placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.2 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
35.5 years
STANDARD_DEVIATION 12.7 • n=107 Participants
|
34.7 years
STANDARD_DEVIATION 12.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ichthyosis Subtype
CIE
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ichthyosis Subtype
EI
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ichthyosis Subtype
LI
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ichthyosis Subtype
NS
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Site
Mount Sinai
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Site
Northwestern
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Weight
|
69.9 kilograms
STANDARD_DEVIATION 13.5 • n=99 Participants
|
75.5 kilograms
STANDARD_DEVIATION 30.4 • n=107 Participants
|
72.4 kilograms
STANDARD_DEVIATION 22.0 • n=206 Participants
|
|
Ichthyosis Area Severity Index (IASI)
|
33.7 units on a scale
STANDARD_DEVIATION 6.5 • n=99 Participants
|
36.2 units on a scale
STANDARD_DEVIATION 4.7 • n=107 Participants
|
34.8 units on a scale
STANDARD_DEVIATION 5.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 16 WeeksPrimary Efficacy Endpoint. The IASI score was modelled after the Eczema Area and Severity Index (EASI) and Psoriasis Area and Severity Index (PASI), commonly used in clinical trials for atopic dermatitis and psoriasis, respectively. This scale measures erythema and scaling and has a range of 0-48 (sum of a max score of 24 for erythema and 24 for scaling). A higher score means worse clinical severity. Mean difference IASI total score at Baseline was compared to IASI total score at Week 16.
Outcome measures
| Measure |
Secukinumab
n=11 Participants
Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
Secukinumab: Anti IL-17A antibody
|
Placebo
n=9 Participants
Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
Placebo
|
Open Label
Participants transitioned to open label treatment with Secukinumab300mg monthly after week 16.
|
|---|---|---|---|
|
Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI)
|
2.4 units on a scale
Interval -7.8 to 12.7
|
4.3 units on a scale
Interval -6.5 to 15.1
|
—
|
PRIMARY outcome
Timeframe: 16 weeks of secukinumab/placebo double blind followed by 32 week open label treatmentPrimary Safety Endpoint
Outcome measures
| Measure |
Secukinumab
n=11 Participants
Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
Secukinumab: Anti IL-17A antibody
|
Placebo
n=9 Participants
Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
Placebo
|
Open Label
n=18 Participants
Participants transitioned to open label treatment with Secukinumab300mg monthly after week 16.
|
|---|---|---|---|
|
Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16
|
5 infections
|
5 infections
|
10 infections
|
Adverse Events
Secukinumab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Open Label
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab
n=11 participants at risk
Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
Secukinumab: Anti IL-17A antibody
|
Placebo
n=9 participants at risk
Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
Placebo
|
Open Label
n=18 participants at risk
Participants transitioned to open label treatment with Secukinumab300mg monthly after week 16.
|
|---|---|---|---|
|
Infections and infestations
Hospitalization-pyelonephritis
|
0.00%
0/11 • 56 weeks
|
0.00%
0/9 • 56 weeks
|
5.6%
1/18 • Number of events 1 • 56 weeks
|
|
Gastrointestinal disorders
Hospitalization-GERD
|
9.1%
1/11 • Number of events 1 • 56 weeks
|
0.00%
0/9 • 56 weeks
|
5.6%
1/18 • Number of events 1 • 56 weeks
|
Other adverse events
| Measure |
Secukinumab
n=11 participants at risk
Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
Secukinumab: Anti IL-17A antibody
|
Placebo
n=9 participants at risk
Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
Placebo
|
Open Label
n=18 participants at risk
Participants transitioned to open label treatment with Secukinumab300mg monthly after week 16.
|
|---|---|---|---|
|
Infections and infestations
Bronchial infection
|
0.00%
0/11 • 56 weeks
|
11.1%
1/9 • Number of events 1 • 56 weeks
|
0.00%
0/18 • 56 weeks
|
|
Infections and infestations
Conjunctivitis
|
9.1%
1/11 • Number of events 1 • 56 weeks
|
0.00%
0/9 • 56 weeks
|
0.00%
0/18 • 56 weeks
|
|
Infections and infestations
Flu-like symptoms
|
9.1%
1/11 • Number of events 1 • 56 weeks
|
0.00%
0/9 • 56 weeks
|
5.6%
1/18 • Number of events 1 • 56 weeks
|
|
Infections and infestations
Otitis externa bacterial
|
0.00%
0/11 • 56 weeks
|
0.00%
0/9 • 56 weeks
|
5.6%
1/18 • Number of events 1 • 56 weeks
|
|
Infections and infestations
Skin Infection
|
0.00%
0/11 • 56 weeks
|
0.00%
0/9 • 56 weeks
|
16.7%
3/18 • Number of events 3 • 56 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
9.1%
1/11 • Number of events 1 • 56 weeks
|
11.1%
1/9 • Number of events 1 • 56 weeks
|
5.6%
1/18 • Number of events 1 • 56 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • 56 weeks
|
11.1%
1/9 • Number of events 1 • 56 weeks
|
11.1%
2/18 • Number of events 3 • 56 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place