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Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease (Divergence2)

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: NCT03077412
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

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 study if they meet eligibility requirements.

Condition or disease Intervention/treatment Phase
Fistulizing Crohn's Disease Drug: Filgotinib Drug: Placebo to match filgotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Filgotinib Dose A
Filgotinib dose A + placebo to match filgotinib dose B for 24 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 Dose B
Filgotinib dose B + placebo to match filgotinib dose A for 24 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: Placebo
Placebo to match filgotinib dose A + placebo to match filgotinib dose B for 24 weeks
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily




Primary Outcome Measures :
  1. Proportion of Participants Establishing Combined Fistula Response at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Proportion of Participants Establishing Combined Fistula Remission at Week 24 [ Time Frame: Week 24 ]
  2. Time to Clinical Fistula Response [ Time Frame: Up to 24 weeks ]
  3. Time to Clinical Fistula Remission [ Time Frame: Up to 24 weeks ]
  4. Proportion of Participants Achieving Proctitis Remission at Week 24 [ Time Frame: Week 24 ]


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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 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 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
    • TNFα Antagonist
  • Is willing and able to undergo MRI per protocol requirements
  • Is willing and able to undergo flexible sigmoidoscopy per protocol requirements

Key Exclusion Criteria:

  • 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

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): NCT03077412


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

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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: NCT03077412     History of Changes
Other Study ID Numbers: GS-US-419-4016
2016-003153-15 ( EudraCT Number )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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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