At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 147 enrolled
Drug / intervention
BI 695501 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
In Brief
A Phase 3 clinical trial evaluating BI 695501 and HUMIRA for Crohn Disease. Completed, enrolled 147 participants across 92 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesBelarus, Bosnia and Herzegovina, Croatia, Czechia, Germany, Greece, Israel, Poland, Russia, Serbia, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartSep 2016
Primary CompletionApr 2019
Study CompletionMay 2019
TodayJul 2026
First PostedAug 18, 2016
Enrollment StartSep 28, 2016
Primary CompletionApr 30, 2019
Study CompletionMay 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.9 years ago
Interventions
BI 695501drug
HUMIRAdrug