Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

NCT03046056 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-419-40152016-003179-23
• Study Type: interventional
• Target: 78
• Locations: 12 countries
• Sites: 38

Brief Summary

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) \< 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

Conditions

Small Bowel Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Clinical Remission at Week 24

  The CDAI score is used to quantify the symptoms of participants with Crohn's Disease (CD). The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of \< 150. A higher score indicates more severe disease.

  Week 24

Secondary Outcomes (14)

• Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24

  Baseline; Week 24

• Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24

  Baseline; Week 24

• Change From Baseline in Jejunum Segmental MaRIA Score at Week 24

  Baseline; Week 24

• Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24

  Week 24

• Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24

  Week 24

Study Arms (3)

Filgotinib 200 mg

EXPERIMENTAL

Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks.

Drug: Filgotinib; Drug: Placebo to match filgotinib

Filgotinib 100 mg

EXPERIMENTAL

Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks.

Drug: Filgotinib; Drug: Placebo to match filgotinib

Placebo

PLACEBO COMPARATOR

PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 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, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit
• Moderately or severely active CD
• Minimum duration of CD of at least 6 months
• Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum
• Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present
• Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
• Corticosteroids
• Immunomodulators
• Tumor necrosis factor-alpha (TNFα) antagonists
• Vedolizumab
• Ustekinumab
• Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements

You may not qualify if:

• Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
• Presence of fistulae
• Evidence of short bowel syndrome
• Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
• History of total colectomy, subtotal-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 (38)

University of Miami Crohn's and Colitis Center

Miami, Florida, 33136, United States

Location

Center for lnterventional Endoscopy- Florida Hospital

Orlando, Florida, 32804, United States

Location

University of South Florida South Tampa campus

Tampa, Florida, 33606, United States

Location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Gastro Center of Maryland

Columbia, Maryland, 21045, United States

Location

Meritus Center for Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Fargo Gastroenterology and Hepatology Clinic

Fargo, North Dakota, 58103, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Texas Clinical Research Institute

Arlington, Texas, 76012, United States

Location

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229, United States

Location

TDDC San Marcos

San Marcos, Texas, 78666, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

McGuire DVAMC

Richmond, Virginia, 23249, United States

Location

Medical University of Innsbruck, Department of Internal Medicine I

Innsbruck, 6020, Austria

Location

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

Vienna, 1090, Austria

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Centre Hospitalier Chretien

Liège, 4000, Belgium

Location

Mount Sinai Hospital

Toronto, M5T 3L9, Canada

Location

PerCuro Clinical Research Ltd.

Victoria, V8V 3M9, Canada

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 500 12, Czechia

Location

CHU de Toulouse -Hopital Rangueil (Main Office)

Toulouse, Midi-Pyrenees, 31059, France

Location

Gastroenterologie, Hepatologie und Endokrinologie

Hanover, 30625, Germany

Location

Universitatsklinikum Jena

Jena, 07747, Germany

Location

Bugát Pál Kórház, Gasztroenterológiai osztály

Gyöngyös, Heves County, 3200, Hungary

Location

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza

Békéscsaba, 5600, Hungary

Location

Azienda Ospedaliero - Universitaria Mater Domini

Catanzaro, 88100, Italy

Location

Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma

Rome, 00128, Italy

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Universitario Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 35016, Spain

Location

Ivano-Frankivsk Central City Clinical Hospital, Department of Therapy #1, SHEI Ivano-Frankivsk National Medical University

Ivano-Frankivsk, 76018, Ukraine

Location

Communal Healthcare Institution Regional Hospital of War Veterans, Department of Therapy #1

Kharkiv, 61137, Ukraine

Location

Communal Institution of Ternopil Regional Council Ternopil University Hospital. Regional Center of Gastroenterology

Ternopil, 46002, Ukraine

Location

Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Royal Devon and Exeter Hospital, Department of Gastroenterology

Exeter, EX2 5DW, United Kingdom

Location

St Georges Clinical Research Facility

London, SW17 0QT, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• Riviere P, D'Haens G, Peyrin-Biroulet L, Baert F, Lambrecht G, Pariente B, Bossuyt P, Buisson A, Oldenburg B, Vermeire S, Laharie D. Location but Not Severity of Endoscopic Lesions Influences Endoscopic Remission Rates in Crohn's Disease: A Post Hoc Analysis of TAILORIX. Am J Gastroenterol. 2021 Jan 1;116(1):134-141. doi: 10.14309/ajg.0000000000000834.

  PMID: 33177349 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: February 6, 2017
• First Posted: February 8, 2017
• Study Start: April 11, 2017
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: August 23, 2021
• Results First Posted: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); UA (3); GB (4); DE (2); IT (2); AU (2); BE (2); US (15); ES (2); FR (1); CA (2); HU (2)