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COMPLETED Phase 3

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

NCT02871635 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG BI 695501
  • DRUG HUMIRA

Study Locations (20)

Florida

  • Borland-Groover Clinic — Jacksonville
  • Hope Clinical Research — Kissimmee
  • Center for Advanced GI — Maitland
  • Advance Medical Research Center — Miami
  • Advanced Research Institute, Inc — New Port Richey

Texas

  • Houston Endoscopy and Research Center — Houston
  • Biopharma Informatic, Inc, dba Research Consultants — Katy
  • Sagact, Pllc — San Antonio
  • Baylor Scott and White Healthcare — Temple
  • Victoria Gastroenterology — Victoria

Maryland

  • MGG Group Co. Inc. / Chevy Chase Clinical Research, — Chevy Chase
  • Gastro Center of Maryland — Columbia

Georgia

  • Doctors Clinical Research — East Point

Illinois

  • Southwest Gastroenterology — Oak Lawn

Kansas

  • University of Kansas Medical Center — Kansas City

Missouri

  • Healthcare Research Network — Hazelwood

North Carolina

  • Asheville Gastroenterology Associates, PA — Asheville

Trial Details

FieldValue
Enrollment Target 147 participants
Start Date 2016-09-28
Est. Completion 2019-05-13
Phase Phase 3

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02871635

The ClinicalTrials.gov registry entry for NCT02871635 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions — of which BI 695501 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02871635 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Texas, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02871635 about?

NCT02871635 is a clinical study titled "BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity". 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-a...

What is the current status of trial NCT02871635?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 147 participants. The study started on 2016-09-28. Estimated completion is 2019-05-13.

What conditions does trial NCT02871635 study?

This clinical trial studies the following conditions: Crohn Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02871635?

The interventions under investigation include: BI 695501 (DRUG), HUMIRA (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02871635?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02871635 being conducted?

This trial has 20 study locations across Florida, Georgia, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial