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

Boehringer Ingelheim147 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

147

Conditions

Crohn Disease

Interventions

BI 695501DRUG

HUMIRADRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (92)

Outcomes

Primary Outcomes

Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4

The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).

Time frame: Week 4

Secondary Outcomes

Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24

The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.

Time frame: Week 24

Percentage of Patients in Clinical Remission (CDAI <150) at Week 24

The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. Patients with CDAI \<150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.

Data from ClinicalTrials.gov

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Borland-Groover Clinic

Jacksonville, Florida, United States

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

...and 82 more locations

Time frame: at Week 24

Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)

Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions.