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
- Conditions
- Moderately to severely active Crohn’s diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-000612-14-HR
- Lead Sponsor
- Boehringer Ingelheim International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 365
1. Males and females aged =18 and =80 years who have a diagnosis of moderate to severely active CD, confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:
a. CDAI score of =220 and =450
b. A diagnosis of CD confirmed by ileocolonoscopy during Screening
c. 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 randomisation.
2. Anti-TNF naïve patients or previously treated with infliximab who had initially responded and who meet one of the following criteria:
a. Responded and developed secondary resistance due confirmed anti-infliximab ADA formation, which caused infliximab depletion
b. Responded and became intolerant
3. Willing to undergo up to 3 endoscopies
4. For participants of reproductive potential, a reliable means of contraception has to be used throughout trial participation.
5. Signed and dated written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1. Ulcerative colitis or indeterminate colitis
2. Symptomatic known obstructive strictures
3. Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while in the trial
4. Ostomy or ileoanal pouch
5. Short bowel syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn’s disease. ;Secondary Objective: To compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases, as covered by CDAI and safety monitoring.;Primary end point(s): Proportion of patients in each treatment group with a clinical response (CDAI decrease of =70) ;Timepoint(s) of evaluation of this end point: Week 4
- Secondary Outcome Measures
Name Time Method