BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

• Status: Completed
• Trial end date: 2019-05-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Adalimumab

Criteria

Inclusion criteria:

• 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

• 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