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

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ClinicalTrials.gov Identifier: NCT03046056
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : January 30, 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, when compared to placebo, in establishing clinical remission in participants with Crohn's disease involving the small bowel. Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 Small Bowel Crohn's Disease (SBCD)
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

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

Placebo Comparator: 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 Achieving Clinical Remission at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Change From Baseline in Magnetic Resonance Imaging (MRI) disease parameters at Week 24 [ Time Frame: Week 24 ]
  2. Proportion of Participants Achieving Small Bowel Remission Measured via MRI Disease Parameters at Week 24 [ Time Frame: Week 24 ]
  3. Proportion of Participants Achieving Remission in the Terminal Ileum Measured via MRI Disease Parameters at Week 24 [ Time Frame: Week 24 ]
  4. Proportion of Participants Achieving Remission in all Bowel Segments via MRI Disease Parameters at Week 24 [ Time Frame: Week 24 ]
  5. Change From Baseline in Patient Reported Symptoms of Abdominal Pain and Liquid Stool Frequency at Week 10 [ Time Frame: Week 10 ]
  6. Change from Baseline in Patient Reported Symptoms of Abdominal Pain and Liquid Stool Frequency 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, 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 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.


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): NCT03046056


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

  Show 61 Study Locations
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03046056     History of Changes
Other Study ID Numbers: GS-US-419-4015
2016-003179-23 ( EudraCT Number )
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases