Trial Outcomes & Findings for BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity (NCT NCT02871635)
NCT ID: NCT02871635
Last Updated: 2020-06-04
Results Overview
The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
147 participants
Primary outcome timeframe
Week 4
Results posted on
2020-06-04
Participant Flow
This was an exploratory, randomized, 56-week, double-blind, parallel arm, multiple dose, active comparator trial of BI 695501 and EU-approved Humira, with a 48-week treatment period and a 10-week follow-up period (starting after last dose of trial medication at Week 46) in patients with moderately to severely active Crohn's Disease (CD)
The trial consisted of a screening period of up to a maximum of 28 days, a 48-week treatment period consisting of an induction period from baseline to Week 4 and a maintenance period from Week 5 to Week 48, and a 10-week safety follow-up period (starting after last dose of trial medication at Week 46).
Participant milestones
| Measure |
BI 695501
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
75
|
|
Overall Study
COMPLETED
|
54
|
56
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
Reasons for withdrawal
| Measure |
BI 695501
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Overall Study
Primary lack of efficacy
|
4
|
4
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Pregnancy
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Secondary lack of efficacy
|
2
|
1
|
Baseline Characteristics
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Baseline characteristics by cohort
| Measure |
BI 695501
n=72 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=75 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 13.44 • n=99 Participants
|
33.2 years
STANDARD_DEVIATION 11.52 • n=107 Participants
|
35.3 years
STANDARD_DEVIATION 12.63 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 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
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
143 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
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Crohn's Disease Activity Index score at baseline
|
307.3 Scores on a scale
STANDARD_DEVIATION 76.69 • n=99 Participants
|
303.6 Scores on a scale
STANDARD_DEVIATION 64.39 • n=107 Participants
|
305.4 Scores on a scale
STANDARD_DEVIATION 70.46 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: The full analysis set (FAS) contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.
The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).
Outcome measures
| Measure |
BI 695501
n=68 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=72 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4
|
88.0 Percentage of participants
|
93.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.
The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.
Outcome measures
| Measure |
BI 695501
n=68 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=72 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24
|
87.4 Percentage of participants
|
87.4 Percentage of participants
|
SECONDARY outcome
Timeframe: at Week 24Population: The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.
The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. Patients with CDAI \<150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.
Outcome measures
| Measure |
BI 695501
n=68 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=72 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Percentage of Patients in Clinical Remission (CDAI <150) at Week 24
|
68.6 Percentage of participants
|
76.2 Percentage of participants
|
SECONDARY outcome
Timeframe: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.Population: The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions.
Outcome measures
| Measure |
BI 695501
n=72 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=75 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
TEAE -Period 1
|
62.5 Percentage of participants
|
56.0 Percentage of participants
|
|
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
serious TEAE - Period 1
|
8.3 Percentage of participants
|
10.7 Percentage of participants
|
|
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
AESI TEAE - Period 1
|
2.8 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
TEAE - Period 2
|
43.1 Percentage of participants
|
45.3 Percentage of participants
|
|
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
serious TEAE - Period 2
|
2.8 Percentage of participants
|
12.0 Percentage of participants
|
|
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
AESI TEAE - Period 2
|
2.8 Percentage of participants
|
2.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Outcome measures
| Measure |
BI 695501
n=72 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=75 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Percentage of Patients With Infections
Period 1
|
23.6 Percentage of participants
|
22.7 Percentage of participants
|
|
Percentage of Patients With Infections
Period 2
|
19.4 Percentage of participants
|
22.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Outcome measures
| Measure |
BI 695501
n=72 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=75 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Percentage of Patients With Serious Infections
Period 1
|
2.8 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Patients With Serious Infections
Period 2
|
1.4 Percentage of participants
|
4.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Outcome measures
| Measure |
BI 695501
n=72 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=75 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Percentage of Patients Who Experienced Hypersensitivity Reactions
Period 1
|
5.6 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Patients Who Experienced Hypersensitivity Reactions
Period 2
|
2.8 Percentage of participants
|
6.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Outcome measures
| Measure |
BI 695501
n=72 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=75 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)
Period 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)
Period 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Outcome measures
| Measure |
BI 695501
n=72 Participants
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira EU
n=75 Participants
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|
|
Percentage of Patients With Injection Site Reactions
Period 1
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Patients With Injection Site Reactions
Period 2
|
1.4 Percentage of participants
|
1.3 Percentage of participants
|
Adverse Events
BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days])
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Humira (Baseline - Week 24 + 10 Weeks [70 Days])
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days])
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Humira (Week 24 - Week 46 + 10 Weeks [70 Days])
Serious events: 9 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days])
n=72 participants at risk
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira (Baseline - Week 24 + 10 Weeks [70 Days])
n=75 participants at risk
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days])
n=72 participants at risk
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira (Week 24 - Week 46 + 10 Weeks [70 Days])
n=75 participants at risk
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Infections and infestations
Acute sinusitis
|
1.4%
1/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.4%
1/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.4%
1/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Gastrointestinal disorders
Crohn's disease
|
2.8%
2/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
6.7%
5/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.4%
1/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Gastrointestinal disorders
Anal fistula
|
1.4%
1/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.4%
1/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar pustulosis
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
Other adverse events
| Measure |
BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days])
n=72 participants at risk
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira (Baseline - Week 24 + 10 Weeks [70 Days])
n=75 participants at risk
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days])
n=72 participants at risk
Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
|
Humira (Week 24 - Week 46 + 10 Weeks [70 Days])
n=75 participants at risk
Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
|
|---|---|---|---|---|
|
Infections and infestations
Respiratory tract infection
|
6.9%
5/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
4.0%
3/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
4.0%
3/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
3/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
6.7%
5/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
2.8%
2/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
2/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
2.7%
2/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
6.9%
5/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
4.0%
3/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Gastrointestinal disorders
Crohn's disease
|
5.6%
4/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
4.0%
3/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
2.7%
2/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
3/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
2.7%
2/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.4%
1/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
6.7%
5/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
6/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
2.8%
2/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
|
Investigations
Weight increased
|
5.6%
4/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
1.3%
1/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
4.2%
3/72 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
0.00%
0/75 • From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
|
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
- Publication restrictions are in place