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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Crohn Disease

Treatments

Drug: HUMIRA

Drug: BI 695501

Study type

Interventional

Funder types

Industry

Identifiers

NCT02871635

2016-000612-14 (EudraCT Number)

1297.4

Details and patient eligibility

About

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.

Enrollment

147 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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