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NCT02871635 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Crohn Disease, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
147
Enrollment target
20
Study locations

NCT02871635 is a Phase 3 study of Crohn Disease that has completed, run by Boehringer Ingelheim. The registered enrollment target is 147 participants, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT02871635, a Phase 3 study of Crohn Disease, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
147 participants
Enrollment target
20
Study locations

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

Crohn Disease

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

515 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, categorized as Phase 3. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (28% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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.

NCT02871635 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Texas, Maryland.

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.

What interventions are being tested in trial NCT02871635?

The interventions under investigation include: BI 695501 (DRUG), HUMIRA (DRUG).

Who is sponsoring clinical trial NCT02871635?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.