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Completed Phase 3 Interventional Results available

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

ClinicalTrials.gov ID: NCT02914561

Public ClinicalTrials.gov record NCT02914561. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 3:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

Study identification

NCT ID
NCT02914561
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Lakefront Biotherapeutics NV
Industry
Enrollment
1,372 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2016 (Actual)
Primary completion
Nov 11, 2022 (Actual)
Completion
Nov 11, 2022 (Actual)
Last update posted
Dec 18, 2023

2016 – 2022

United States locations

U.S. sites
101
U.S. states
34
U.S. cities
85
Facility City State ZIP Site status
Digestive Health Specialists of the Southeast Dothan Alabama 36305 —
Arizona Digestive Health - Sun City Sun City Arizona 85351 —
Southern California Research Center, Inc. Coronado California 92118 —
VVCRD Research Garden Grove California 92845 —
UC San Diego Health System La Jolla California 92037 —
Cedars Sinai Medical Center Los Angeles California 90048 —
Inland Empire Clinical Trials, LLC Rialto California 92377 —
Kaiser Permanente San Francisco California 94118 —
Clearview Medical Research, LLC Santa Clarita California 91351 —
University of Colorado Denver and Hospital Aurora Colorado 80045 —
South Denver Gastroenterology, PC Lone Tree Colorado 80124 —
Connecticut GI, PC-Research Division Farmington Connecticut 06032 —
Medstar Georgetown University Hospital (Patient Exams) Washington D.C. District of Columbia 20007 —
Advanced Research, LLC Coral Springs Florida 33067 —
UF Clinical Research Center Gainesville Florida 32610 —
Florida Research Institute Lakewood Rch Florida 34211 —
Florida Center for Gastroenterology Largo Florida 33777 —
University of Miami Crohn's and Colitis Center Miami Florida 33136 —
Advanced Pharma CR Miami Florida 33147 —
Cordova Research Institute Miami Florida 33155 —
Vista Health Research, LLC Miami Florida 33176 —
Gastroenterology Group of Naples Naples Florida 34102 —
Center for Interventional Endoscopy - AdventHealth Orlando Orlando Florida 32803 —
Gulf Region Clinical Research Institute Pensacola Florida 32514 —
Advanced Medical Research Center Port Orange Florida 32127 —
Tampa General Hospital Tampa Florida 33606 —
Shafran Gastroenterology Center Winter Park Florida 32789 —
Florida Medical Clinic, P.A. Zephyrhills Florida 33540 —
Gastroenterology Associates of Central Georgia, LLC Macon Georgia 31201 —
Gastrointestinal Specialists of Georgia Marietta Georgia 30060 —
Atlanta Gastroenterology Specialist, PC Suwanee Georgia 30024 —
Illinois Gastroenterology Group - Arlington Heights Arlington Heights Illinois 60005 —
Northwestern University, Feinberg School of Medicine Chicago Illinois 60611 —
University of Chicago Medical Center Chicago Illinois 60637 —
Illinois Gastroenterology Group - Gurnee Gurnee Illinois 60031 —
Indiana University Health University Hospital Indianapolis Indiana 46202 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
University of Kansas Medical Center Kansas City Kansas 66160 —
University of Louisville, School of Medicine Louisville Kentucky 40202 —
Delta Research Partners, LLC Monroe Louisiana 71201 —
Louisiana Research Center, LLC Shreveport Louisiana 71105 —
Investigative Clinical Research Annapolis Maryland 21401 —
University of Maryland Medical Center Baltimore Maryland 21201 —
MGG Group Co., Inc., Chevy Chase Clinical Research Chevy Chase Maryland 20815 —
Gastro Center of Maryland Columbia Maryland 21045 —
Meritus Center for Clinical Research Hagerstown Maryland 21742 —
Massachusetts General Hospital - Crohn's and Colitis Center Boston Massachusetts 02114 —
Clinical Research Institute of Michigan, LLC Chesterfield Michigan 48047 —
Spectrum Health Butterworth Hospital Grand Rapids Michigan 49546 —
Mayo Clinic Rochester Minnesota 55902 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Kansas City Research Institute Kansas City Missouri 64131 —
Washington University School of Medicine St Louis Missouri 63110 —
Las Vegas Medical Research Las Vegas Nevada 89113 —
AGA Clinical Research Associates, LLC Egg Harbor New Jersey 08234 —
NY Scientific Brooklyn New York 11235 —
NYU Langone Long Island Clinical Research Associates Great Neck New York 11021 —
New York University School of Medicine/NYU Gastroenterology Associates New York New York 10016 —
Lenox Hill Hospital New York New York 10028 —
Premier Medical Group of the Hudson Valley Poughkeepsie New York 12601 —
Charlotte Gastroenterology & Hepatology, PLLC Charlotte North Carolina 28207 —
Carolina's GI Research, LLC Raleigh North Carolina 27607 —
Fargo Gastroenterology and Hepatology Clinic Fargo North Dakota 58103 —
Consultants for Clinical Research Cincinnati Ohio 45219 —
UC Health Physicians Clifton Cincinnati Ohio 45219 —
Great Lakes Gastroenterology Research, LLC, Mentor Ohio 44060 —
Paramount Medical Research & Consulting, LLC Middleburg Heights Ohio 44130 —
Options Health Research LLC Tulsa Oklahoma 74104 —
Great Lakes Medical Research, LLC Harrisburg Pennsylvania 17110 —
Gastroenterology Associates of Orangeburg Orangeburg South Carolina 29118 —
WR-ClinSearch, LLC Chattanooga Tennessee 37421 —
Gastro One Germantown Tennessee 38138 —
Quality Medical Research Nashville Tennessee 37211 —
Vanderbilt University Medical Center - IBD Clinic Nashville Tennessee 37212 —
Texas Clinical Research Institute Arlington Texas 76012 —
Pinnacle Clinical Research Austin Texas 78757 —
Inquest Clinical Research Baytown Texas 77521 —
San Antonio Military Medical Center Fort Sam Houston Texas 78219 —
DHAT Research Institute Garland Texas 75044 —
Kelsey-Seybold Clinic Houston Texas 77025 —
Baylor College of Medicine- Baylor Medical Center Houston Texas 77030 —
The Methodist Hospital Houston Texas 77030 —
The University of Texas Health Science Center at Houston Houston Texas 77030 —
Centex Studies, Inc. Houston Texas 77058 —
Gulf Coast Research Group Houston Texas 77098 —
Clinical Associates in Research Therapeutics of America, LLC San Antonio Texas 78212 —
Gastroenterology Research of San Antonio San Antonio Texas 78229 —
Pinnacle Clinical Research San Antonio Texas 78229 —
TDDC San Marcos San Marcos Texas 78666 —
Texas Digestive Disease Consultants (IP Shipment) Southlake Texas 76092 —
Spring Gastroenterology The Woodlands Texas 77380 —
Tyler Research Institute, LLC Tyler Texas 75701 —
HP Clinical Research Bountiful Utah 84010 —
University of Virginia Health System Charlottesville Virginia 22908 —
Charlottesville Medical Research Center, LLC Charlottesville Virginia 22911 —
Gastroenterology Associates of Tidewater Chesapeake Virginia 23320 —
Emeritas Research Group LLC Leesburg Virginia 20176 —
McGuire DVAMC, GI (111N) Richmond Virginia 23249 —
Virginia Commonwealth University Richmond Virginia 23298 —
University of Wisconsin Hospital & Clinics Madison Wisconsin 53792 —
Wisconsin Center for Advanced Research, a division of GI Associates, LLC Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 412 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02914561, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 18, 2023 · Synced Oct 27, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02914561 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →