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Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease

NCT02914600•Galapagos NV

Summary

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
•Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
•Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
•Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
•Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
•Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD

Exclusion Criteria

•Known hypersensitivity to the study drug
•Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol
•Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
•Use of prohibited concomitant medications as outlined in the study protocol

Locations (486)

Digestive Health Specialists Of The Southeast

Dothan, Alabama, United States

Arizona Digestive Health - Sun City

Sun City, Arizona, United States

Southern California Research Center, Inc.

Coronado, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Inland Empire Clinical Trials, LLC

Rialto, California, United States

UC San Diego Health Systems

San Diego, California, United States

Kaiser Permanente

San Francisco, California, United States

Clearview Medical Research, LLC

Santa Clarita, California, United States

University of Colorado Denver and Hospital

Aurora, Colorado, United States

South Denver Gastroenterology, PC

Lone Tree, Colorado, United States

Key Dates

Start Date

March 17, 2017

Primary Completion Date

August 1, 2023

Completion Date

August 1, 2023

Last Updated

July 10, 2024

Enrollment

1,188

ACTUAL participants

Conditions

Crohn's Disease

Interventions

Filgotinib

DRUG

Placebo

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease