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

Completed · Phase 3

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT02871635

Run by

Boehringer Ingelheim

People needed

147

Starts

2016-09-28

Expected to finish

2019-05-13

Last updated by the study team

2020-06-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hope Clinical Research — Kissimmee, Florida, United States
• Center for Advanced GI — Maitland, Florida, United States
• Advance Medical Research Center — Miami, Florida, United States
• Advanced Research Institute, Inc — New Port Richey, Florida, United States
• Doctors Clinical Research — East Point, Georgia, United States
• Southwest Gastroenterology — Oak Lawn, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• MGG Group Co. Inc. / Chevy Chase Clinical Research, — Chevy Chase, Maryland, United States
• Gastro Center of Maryland — Columbia, Maryland, United States
• Healthcare Research Network — Hazelwood, Missouri, United States
• Asheville Gastroenterology Associates, PA — Asheville, North Carolina, United States
• Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States
• Gastroenterology Associates, PA — Greenville, South Carolina, United States
• Houston Endoscopy and Research Center — Houston, Texas, United States
• Biopharma Informatic, Inc, dba Research Consultants — Katy, Texas, United States
• Sagact, Pllc — San Antonio, Texas, United States
• Baylor Scott and White Healthcare — Temple, Texas, United States
• Victoria Gastroenterology — Victoria, Texas, United States
• Gomel Regional Clinical — Homyel, Belarus
• City Clinical Hospital # 10 — Minsk, Belarus
• Vitebsk Regional Clinical Oncology Dispensary — Vitebsk, Belarus
• University Clinical Centre Sarajevo — Sarajevo, Bosnia and Herzegovina
• Clinical Hospital Osijek — Osijek, Croatia
• Polyclinic Bonifarm — Zagreb, Croatia
• Borland-Groover Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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