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Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) (Divergence1)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03046056
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : August 7, 2020
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 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
Actual Primary Completion Date : July 20, 2020
Actual Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Filgotinib 200 mg
Filgotinib 200 mg + placebo to match filgotinib 100 mg 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 100 mg
Filgotinib 100 mg + placebo to match filgotinib 200 mg 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 200 mg + placebo to match filgotinib 100 mg 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 Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24 [ Time Frame: Baseline, Week 24 ]
    The MaRIA score is used to assess radiographic disease activity in Crohn's Disease. 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. A higher score indicates more severe disease.

  2. Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24 [ Time Frame: Baseline, Week 24 ]
    The MaRIA score is used to assess radiographic disease activity in Crohn's Disease. 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. A higher score indicates more severe disease.

  3. Change From Baseline in Jejunum Segmental MaRIA Score at Week 24 [ Time Frame: Baseline, Week 24 ]
    The MaRIA score is used to assess radiographic disease activity in Crohn's Disease. 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. A higher score indicates more severe disease.

  4. Proportion of Participants Achieving MaRIA Remission in Terminal Ileum Segment at Week 24 [ Time Frame: Week 24 ]
  5. Proportion of Participants Achieving MaRIA Remission in Distal Ileum Segment at Week 24 [ Time Frame: Week 24 ]
  6. Proportion of Participants Achieving MaRIA Remission in Jejunum Segment at Week 24 [ Time Frame: Week 24 ]
  7. Proportion of Participants Achieving MaRIA Response in Terminal Ileum Segment at Week 24 [ Time Frame: Week 24 ]
  8. Proportion of Participants Achieving MaRIA Response in Distal Ileum Segment at Week 24 [ Time Frame: Week 24 ]
  9. Proportion of Participants Achieving MaRIA Response in Jejunum Segment at Week 24 [ Time Frame: Week 24 ]
  10. Proportion of Participants Achieving Participant Level Small Bowel MaRIA Remission at Week 24 [ Time Frame: Week 24 ]
  11. Proportion of Participants Achieving Participant Level Small Bowel MaRIA Response at Week 24 [ Time Frame: Week 24 ]
  12. Proportion of Participants Achieving Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 [ Time Frame: Week 10 ]
  13. Change From Baseline in CDAI Scores at Week 10 [ Time Frame: Baseline, Week 10 ]
    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. An increase in the score indicates disease worsening.

  14. Change From Baseline in CDAI Scores at Week 24 [ Time Frame: Baseline, 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. An increase in the score indicates disease worsening.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
Show Show 39 study locations
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: NCT03046056    
Other Study ID Numbers: GS-US-419-4015
2016-003179-23 ( EudraCT Number )
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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