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Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) (DIVERGENCE 1)

Primary Purpose

Small Bowel Crohn's Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Filgotinib

Placebo to match filgotinib

About this trial

This is an interventional treatment trial for Small Bowel Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

University of Miami Crohn's and Colitis Center
Center for lnterventional Endoscopy- Florida Hospital
University of South Florida South Tampa campus
Indiana University Health University Hospital
University of Kansas Medical Center
Gastro Center of Maryland
Meritus Center for Clinical Research
Clinical Research Institute of Michigan
Fargo Gastroenterology and Hepatology Clinic
Gastro One
Texas Clinical Research Institute
Gastroenterology Research of San Antonio
TDDC San Marcos
Texas Digestive Disease Consultants
McGuire DVAMC
Medical University of Innsbruck, Department of Internal Medicine I
Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
Universitair Ziekenhuis Antwerpen
Centre Hospitalier Chretien
Mount Sinai Hospital
PerCuro Clinical Research Ltd.
Hepato-Gastroenterologie HK, s.r.o.
CHU de Toulouse -Hopital Rangueil (Main Office)
Gastroenterologie, Hepatologie und Endokrinologie
Universitatsklinikum Jena
Bugát Pál Kórház, Gasztroenterológiai osztály
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza
Azienda Ospedaliero - Universitaria Mater Domini
Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma
Hospital Universitario de Fuenlabrada
Hospital Universitario Gran Canaria Dr. Negrin
Ivano-Frankivsk Central City Clinical Hospital, Department of Therapy #1, SHEI Ivano-Frankivsk National Medical University
Communal Healthcare Institution Regional Hospital of War Veterans, Department of Therapy #1
Communal Institution of Ternopil Regional Council Ternopil University Hospital. Regional Center of Gastroenterology
Queen Elizabeth University Hospital
Royal Devon and Exeter Hospital, Department of Gastroenterology
St Georges Clinical Research Facility
John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Filgotinib 200 mg

Filgotinib 100 mg

Placebo

Arm Description

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

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

PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Magnetic resonance enterography (MRE) is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system. The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and relative contrast enhancement (RCE). A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these components for the terminal ileum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening.

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

MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system. The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening.

Change From Baseline in Jejunum Segmental MaRIA Score at Week 24

MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system.The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A positive change from baseline indicates disease worsening.

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

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in terminal ileum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.

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

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in distal ileum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.

Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in jejunum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.

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

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ minimum detectable difference (MDD) units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the terminal ileum. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units.

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

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score≥ 7 in the distal ileum. For segments with baseline MaRIA score ≥ 15, the minimum detectable difference (MDD) is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units.

Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the jejunum. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units.

Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Small bowel MaRIA remission was defined as MaRIA score < 7 at Week 24 in each of the 3 small bowel segments, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline.

Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Participant level small bowel MaRIA response was defined as all small bowel segments with baseline MaRIA score ≥7 achieve segment level MaRIA response, with no segment level disease worsening in any other segment(s) at Week 24, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline.

Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10

The CDAI score is used to quantify the symptoms of participants with 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.

Change From Baseline in CDAI Scores at Week 10

The CDAI score is used to quantify the symptoms of participants with CD. The score ranges from 0 to 600. A score of < 150 indicates remission. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement.

Change From Baseline in CDAI Scores at Week 24

The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The score ranges from 0 to 600. A score of < 150 indicates remission. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement.

Full Information

NCT ID

NCT03046056

First Posted

February 6, 2017

Last Updated

August 20, 2021

Sponsor

Gilead Sciences

Collaborators

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT03046056

Brief Title

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

Acronym

DIVERGENCE 1

Official Title

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

April 11, 2017 (Actual)

Primary Completion Date

July 20, 2020 (Actual)

Study Completion Date

July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

Collaborators

Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Bowel Crohn's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Filgotinib 200 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Filgotinib 100 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks.

Intervention Type

Drug

Intervention Name(s)

Filgotinib

Other Intervention Name(s)

GS-6034, GLPG0634

Intervention Description

Tablet(s) administered orally once daily

Intervention Type

Drug

Intervention Name(s)

Placebo to match filgotinib

Intervention Description

Tablet(s) administered orally once daily

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved Clinical Remission at Week 24

Description

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline; Week 24

Title

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

Description

Time Frame

Baseline; Week 24

Title

Change From Baseline in Jejunum Segmental MaRIA Score at Week 24

Description

MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system.The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A positive change from baseline indicates disease worsening.

Time Frame

Baseline; Week 24

Title

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

Description

Time Frame

Week 24

Title

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

Description

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in distal ileum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.

Time Frame

Week 24

Title

Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24

Description

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in jejunum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.

Time Frame

Week 24

Title

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

Description

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ minimum detectable difference (MDD) units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the terminal ileum. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units.

Time Frame

Week 24

Title

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

Description

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score≥ 7 in the distal ileum. For segments with baseline MaRIA score ≥ 15, the minimum detectable difference (MDD) is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units.

Time Frame

Week 24

Title

Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24

Description

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the jejunum. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units.

Time Frame

Week 24

Title

Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24

Description

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Small bowel MaRIA remission was defined as MaRIA score < 7 at Week 24 in each of the 3 small bowel segments, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline.

Time Frame

Week 24

Title

Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24

Description

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Participant level small bowel MaRIA response was defined as all small bowel segments with baseline MaRIA score ≥7 achieve segment level MaRIA response, with no segment level disease worsening in any other segment(s) at Week 24, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline.

Time Frame

Week 24

Title

Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10

Description

Time Frame

Week 10

Title

Change From Baseline in CDAI Scores at Week 10

Description

Time Frame

Baseline; Week 10

Title

Change From Baseline in CDAI Scores at Week 24

Description

Time Frame

Baseline; Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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 Key Exclusion Criteria: 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

University of Miami Crohn's and Colitis Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Center for lnterventional Endoscopy- Florida Hospital

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

University of South Florida South Tampa campus

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Indiana University Health University Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Gastro Center of Maryland

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21045

Country

United States

Facility Name

Meritus Center for Clinical Research

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21742

Country

United States

Facility Name

Clinical Research Institute of Michigan

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Fargo Gastroenterology and Hepatology Clinic

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Gastro One

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Texas Clinical Research Institute

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

Gastroenterology Research of San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

TDDC San Marcos

City

San Marcos

State/Province

Texas

ZIP/Postal Code

78666

Country

United States

Facility Name

Texas Digestive Disease Consultants

City

Southlake

State/Province

Texas

ZIP/Postal Code

76092

Country

United States

Facility Name

McGuire DVAMC

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

Medical University of Innsbruck, Department of Internal Medicine I

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

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

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Universitair Ziekenhuis Antwerpen

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Centre Hospitalier Chretien

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Mount Sinai Hospital

City

Toronto

ZIP/Postal Code

M5T 3L9

Country

Canada

Facility Name

PerCuro Clinical Research Ltd.

City

Victoria

ZIP/Postal Code

V8V 3M9

Country

Canada

Facility Name

Hepato-Gastroenterologie HK, s.r.o.

City

Hradec Kralove

ZIP/Postal Code

500 12

Country

Czechia

Facility Name

CHU de Toulouse -Hopital Rangueil (Main Office)

City

Toulouse Cedex 9

State/Province

Midi-Pyrenees

ZIP/Postal Code

31059

Country

France

Facility Name

Gastroenterologie, Hepatologie und Endokrinologie

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitatsklinikum Jena

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

Bugát Pál Kórház, Gasztroenterológiai osztály

City

Gyöngyös

State/Province

Heves

ZIP/Postal Code

3200

Country

Hungary

Facility Name

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza

City

Békéscsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

Azienda Ospedaliero - Universitaria Mater Domini

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma

City

Rome

ZIP/Postal Code

00128

Country

Italy

Facility Name

Hospital Universitario de Fuenlabrada

City

Fuenlabrada

State/Province

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Hospital Universitario Gran Canaria Dr. Negrin

City

Las Palmas De Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

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

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

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

City

Kharkiv

ZIP/Postal Code

61137

Country

Ukraine

Facility Name

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

City

Ternopil

ZIP/Postal Code

46002

Country

Ukraine

Facility Name

Queen Elizabeth University Hospital

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Royal Devon and Exeter Hospital, Department of Gastroenterology

City

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

St Georges Clinical Research Facility

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

John Radcliffe Hospital

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33177349

Citation

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.

Results Reference

derived

Learn more about this trial

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

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