BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
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| ClinicalTrials.gov Identifier: NCT02871635 |
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Recruitment Status :
Completed
First Posted : August 18, 2016
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
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Primary Objective:
The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD).
Secondary Objectives:
The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Crohn Disease | Drug: BI 695501 Drug: HUMIRA | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 147 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity |
| Actual Study Start Date : | September 28, 2016 |
| Actual Primary Completion Date : | April 30, 2019 |
| Actual Study Completion Date : | May 13, 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: BI 695501 |
Drug: BI 695501 |
| Active Comparator: HUMIRA + BI 695501 |
Drug: BI 695501 Drug: HUMIRA |
- Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4 [ Time Frame: Week 4 ]
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).
- Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24 [ Time Frame: Week 24 ]
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.
- Percentage of Patients in Clinical Remission (CDAI <150) at Week 24 [ Time Frame: at Week 24 ]
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.
- Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) [ Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. ]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.
- Percentage of Patients With Infections [ Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. ]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.
- Percentage of Patients With Serious Infections [ Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. ]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.
- Percentage of Patients Who Experienced Hypersensitivity Reactions [ Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. ]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.
- Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI) [ Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. ]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.
- Percentage of Patients With Injection Site Reactions [ Time Frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. ]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.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
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Males and females aged >=18 and =<80 years at Screening who have a diagnosis of moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:
- Crohn's Disease Activity Index (CDAI) score of >=220 and =<450
- A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening
- Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization
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Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria:
- Responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion
- Responded and became intolerant
- Further inclusion criteria apply
Exclusion criteria:
- Patients with ulcerative colitis or indeterminate colitis
- Patients with symptomatic known obstructive strictures
- Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while enrolled in the trial
- Patients with an ostomy or ileoanal pouch
- Patients with short bowel syndrome
- Patients who have previously used infliximab and have never clinically responded
- Patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial
- Further exclusion criteria apply
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871635
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| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Documents provided by Boehringer Ingelheim:
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT02871635 |
| Other Study ID Numbers: |
1297.4 2016-000612-14 ( EudraCT Number ) |
| First Posted: | August 18, 2016 Key Record Dates |
| Results First Posted: | June 4, 2020 |
| Last Update Posted: | June 4, 2020 |
| Last Verified: | May 2020 |
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |