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Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease (Diversity1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02914561
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

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 (Gilead Study GS-US-419-3896).


Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Filgotinib Drug: Placebo to match filgotinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 31, 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Filgotinib 200 mg (Induction Study)
Filgotinib 200 mg + placebo to match filgotinib 100 mg for 10 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Experimental: Filgotinib 100 mg (Induction Study)
Filgotinib 100 mg + placebo to match filgotinib 200 mg for 10 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Placebo Comparator: Placebo (Induction Study)
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 10 weeks
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Experimental: Maintenance Study
Participants who meet response or remission criteria at Week 10 will continue into the Maintenance Study and receive filgotinib and/or placebo for 48 weeks.
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily




Primary Outcome Measures :
  1. Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10 [ Time Frame: Week 10 ]
  2. Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10 [ Time Frame: Week 10 ]
  3. Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 [ Time Frame: Week 58 ]
  4. Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58 [ Time Frame: Week 58 ]

Secondary Outcome Measures :
  1. Induction Study: Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 [ Time Frame: Week 10 ]
  2. Induction Study: Proportion of Participants Achieving Both Clinical Remission by PRO2 and endoscopic response at Week 10 (Composite Endpoint) [ Time Frame: Week 10 ]
  3. Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ]
  4. Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58 [ Time Frame: Week 58 ]
  5. Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2 at Weeks 10 and 58 [ Time Frame: Weeks 10 and 58 ]
  6. Maintenance Study: Proportion of Participants Achieving Both Clinical Remission by PRO2 and Endoscopic Response at Week 58 (Composite Endpoint) [ Time Frame: Week 58 ]
  7. Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58 [ Time Frame: Week 58 ]
  8. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 26 (predose or postdose) and Week 58 predose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
  • Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
  • Moderately to severely active CD
  • Cohort A (Biologic Naïve): 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 and immunomodulators
  • Cohort A (Biologic Experienced): 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) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
  • Cohort B (Biologic Experienced): 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): TNFa antagonists, vedolizumab, and ustekinumab

Key Exclusion Criteria:

  • Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
  • Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
  • Active tuberculosis (TB) or history of latent TB that has not been treated
  • Use of any prohibited concomitant medications as described in the study protocol

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914561


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02914561    
Other Study ID Numbers: GS-US-419-3895
2016-001367-36 ( EudraCT Number )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases