BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

Phase 1

• Conditions: Moderately to severely active Crohn’s disease; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2016-000612-14-DE
• Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-05
• Study Completion: 2019-05-13
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 365

Inclusion Criteria

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

Exclusion Criteria

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