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Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis (SELECTION1)

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ClinicalTrials.gov Identifier: NCT02914522
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) 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-418-3899).


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Filgotinib Drug: Placebo to match filgotinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Combined Phase 2b/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 Ulcerative Colitis
Actual Study Start Date : November 14, 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Filgotinib Dose A (Induction Study)
Filgotinib dose A + placebo to match filgotinib dose B 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 Dose B (Induction Study)
Filgotinib dose B + placebo to match filgotinib dose A 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 dose A + placebo to match dose B 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 Maintenance Study and will 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


Outcome Measures
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Primary Outcome Measures :
  1. Induction Study: Proportion of Participants Achieving Remission Based on Components of Mayo Clinic Score (MCS) at Week 10 [ Time Frame: Week 10 ]
  2. Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ]

Secondary Outcome Measures :
  1. Induction Study: Proportion of Participants Achieving MCS Remission at Week 10 [ Time Frame: Week 10 ]
  2. Induction Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10 [ Time Frame: Week 10 ]
  3. Induction Study: Proportion of Participants Achieving Histologic Remission at Week 10 [ Time Frame: Week 10 ]
  4. Induction Study: Proportion of participants achieving MCS remission (alternative definition) at Week 10 [ Time Frame: Week 10 ]
  5. Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ]
  6. Maintenance Study: Proportion of Participants Achieving MCS Remission at Week 58 [ Time Frame: Week 58 ]
  7. Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Weeks 10 and 58 [ Time Frame: Weeks 10 and 58 ]
  8. Maintenance Study: Proportion of Participants Achieving 6-Month Corticosteroid-Free Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ]
  9. Maintenance Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 58 [ Time Frame: Weeks 58 ]
  10. Maintenance Study: Proportion of Participants Achieving Histologic Remission at Week 58 [ Time Frame: Week 58 ]
  11. Maintenance Study: Proportion of participants achieving MCS remission (alternative definition) at Week 58 [ Time Frame: Week 58 ]
  12. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 26 (predose or postdose) and Week 58 predose ]

Eligibility Criteria
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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 UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
  • A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
  • Moderately to severely active UC
  • 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 (TNFa) antagonists, or vedolizumab

Key Exclusion Criteria:

  • Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
  • Active tuberculosis (TB) or history of latent TB that has not been treated
  • Use of any concomitant prohibited medications as described in the protocol

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

Contacts and Locations
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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): NCT02914522


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
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02914522     History of Changes
Other Study ID Numbers: GS-US-418-3898
2016-001392-78 ( EudraCT Number )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 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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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases