Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

NCT03077412 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-419-40162016-003153-15
• Study Type: interventional
• Target: 57
• Locations: 9 countries
• Sites: 27

Brief Summary

The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.

Conditions

Fistulizing Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Combined Fistula Response at Week 24

  Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections \> 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.

  Week 24

Secondary Outcomes (4)

• Percentage of Participants Who Achieved Combined Fistula Remission at Week 24

  Week 24

• Time to Clinical Fistula Response up to Week 24

  Time from treatment start to first visit when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieved perianal fistula closure up to Week 24

• Time to Clinical Fistula Remission up to Week 24

  Time from treatment start to first visit when perianal fistula closure takes place of all external openings that were draining at baseline up to Week 24

• Percentage of Participants Who Achieved Proctitis Remission at Week 24

  Week 24

Study Arms (3)

Filgotinib 200 mg

EXPERIMENTAL

Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks

Drug: Filgotinib; Drug: Placebo to match filgotinib

Filgotinib 100 mg

EXPERIMENTAL

Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks

Drug: Filgotinib; Drug: Placebo to match filgotinib

Placebo

EXPERIMENTAL

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks

Drug: Placebo to match filgotinib

Interventions

Filgotinib DRUG

Tablet(s) administered orally once daily

Also known as: GS-6034, GLPG0634

Filgotinib 100 mg; Filgotinib 200 mg

Placebo to match filgotinib DRUG

Tablet(s) administered orally once daily

Filgotinib 100 mg; Filgotinib 200 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
• Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months
• Has draining perianal fistulae as a complication of CD, confirmed by magnetic resonance imaging (MRI) at screening
• Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
• Antibiotics AND/OR
• Immunomodulators AND/OR
• Tumor necrosis factor α (TNFα) Antagonist
• Is willing and able to undergo MRI per protocol requirements
• Is willing and able to undergo flexible sigmoidoscopy per protocol requirements

You may not qualify if:

• Presence of current rectovaginal anovaginal or enterovesicular fistulae
• Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
• History of total proctocolectomy, total colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
• Use of any prohibited concomitant medications as described in the study protocol
• Active tuberculosis (TB) or history of latent TB that has not been treated

Sponsors & Collaborators

• Gilead Sciences: lead
• Galapagos NV: collaborator

Study Sites (27)

University of Miami Crohn's and Colitis Center

Miami, Florida, 33136, United States

Location

Center for Interventional Endoscopy - Florida Hospital

Orlando, Florida, 32804, United States

Location

University of South Florida South Tampa Campus

Tampa, Florida, 33606, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Louisville Clinical Trials Unit

Louisville, Kentucky, 40202, United States

Location

John Hopkins Gastroenterology and Hepatology Services at the Green Spring Station Clinic

Baltimore, Maryland, 21224, United States

Location

Gastro Center of Maryland

Columbia, Maryland, 21045, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center - IBD Clinic

Nashville, Tennessee, 37212-2702, United States

Location

Texas Clinical Research Institute

Arlington, Texas, 76012, United States

Location

DHAT Research Institute

Garland, Texas, 75044, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

McGuire DVAMC

Richmond, Virginia, 23249, United States

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology

Vienna, 1090, Austria

Location

Universitaire Ziekenhuizen Leuven

Leuven, B-3000, Belgium

Location

Mount Sinai Hospital

Toronto, M5T 3L9, Canada

Location

Toronto Digestive Disease Associates Inc.

Toronto, M9V 4B8, Canada

Location

CHU Grenoble Alpes - Hopital Michallon (main office)

La Tronche, 38700, France

Location

CHU de Rennes - Hôpital Pontchaillou (main office)

Rennes, 85809, France

Location

CHU Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, 01307, Germany

Location

Universitatsklinkum Jena

Jena, 07747, Germany

Location

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza

Békéscsaba, Bekes County, 5600, Hungary

Location

Bugát Pál Kórház, Gasztroenterológiai osztály

Gyöngyös, Heves County, 3200, Hungary

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Royal Devon and Exeter Hospital, Department of Gastroenterology

Exeter, EX2 5DW, United Kingdom

Location

Related Publications (1)

• Reinisch W, Colombel JF, D'Haens GR, Rimola J, Masior T, McKevitt M, Ren X, Serone A, Schwartz DA, Gecse KB. Efficacy and Safety of Filgotinib for the Treatment of Perianal Fistulising Crohn's Disease [DIVERGENCE 2]: A Phase 2, Randomised, Placebo-controlled Trial. J Crohns Colitis. 2024 Jun 3;18(6):864-874. doi: 10.1093/ecco-jcc/jjae003.

  PMID: 38366672 DERIVED

MeSH Terms

Interventions

GLPG0634

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 13, 2017
• Study Start: April 6, 2017
• Primary Completion: January 20, 2021
• Study Completion: February 17, 2021
• Last Updated: April 8, 2022
• Results First Posted: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); HU (2); AU (2); US (13); BE (1); FR (3); IT (1); GB (1); CA (2)