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Trial record 1 of 1 for:    GS-US-418-3898
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Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis (SELECTION1)

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: NCT02914522
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE September 22, 2016
First Posted Date  ICMJE September 26, 2016
Last Update Posted Date May 4, 2020
Actual Study Start Date  ICMJE November 14, 2016
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • Induction Study: Proportion of Participants Achieving Remission Based on Components of Mayo Clinic Score (MCS) at Week 10 [ Time Frame: Week 10 ]
  • Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • Induction Study: Proportion of Participants Achieving MCS Remission at Week 10 [ Time Frame: Week 10 ]
  • Induction Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10 [ Time Frame: Week 10 ]
  • Induction Study: Proportion of Participants Achieving Histologic Remission at Week 10 [ Time Frame: Week 10 ]
  • Induction Study: Proportion of participants achieving MCS remission (alternative definition) at Week 10 [ Time Frame: Week 10 ]
  • Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ]
  • Maintenance Study: Proportion of Participants Achieving MCS Remission at Week 58 [ Time Frame: Week 58 ]
  • Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Weeks 10 and 58 [ Time Frame: Weeks 10 and 58 ]
  • Maintenance Study: Proportion of Participants Achieving 6-Month Corticosteroid-Free Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ]
  • Maintenance Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 58 [ Time Frame: Weeks 58 ]
  • Maintenance Study: Proportion of Participants Achieving Histologic Remission at Week 58 [ Time Frame: Week 58 ]
  • Maintenance Study: Proportion of participants achieving MCS remission (alternative definition) at Week 58 [ Time Frame: Week 58 ]
  • Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 26 (predose or postdose) and Week 58 predose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • Induction Study: Proportion of Participants Achieving MCS Remission at Week 10 [ Time Frame: Week 10 ]
  • Induction Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10 [ Time Frame: Week 10 ]
  • Induction Study: Proportion of Participants Achieving Histologic Remission at Week 10 [ Time Frame: Week 10 ]
  • Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ]
  • Maintenance Study: Proportion of Participants Achieving MCS Remission at Week 58 [ Time Frame: Week 58 ]
  • Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Weeks 10 and 58 [ Time Frame: Weeks 10 and 58 ]
  • Maintenance Study: Proportion of Participants Achieving 6-Month Corticosteroid-Free Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ]
  • Maintenance Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 58 [ Time Frame: Weeks 58 ]
  • Maintenance Study: Proportion of Participants Achieving Histologic Remission at Week 58 [ Time Frame: Week 58 ]
  • Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 26 (predose or postdose) and Week 58 predose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE 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
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Names:
    • GS-6034
    • GLPG0634
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily
Study Arms  ICMJE
  • Experimental: Filgotinib 200 mg (Induction Study)
    Filgotinib 200 mg + placebo to match filgotinib 100 mg for 10 weeks
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
  • Experimental: Filgotinib 100 mg (Induction Study)
    Filgotinib 100 mg + placebo to match filgotinib 200 mg for 10 weeks
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
  • Placebo Comparator: Placebo (Induction Study)
    Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 10 weeks
    Intervention: Drug: Placebo to match filgotinib
  • 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.
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2019)
1351
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2016)
1300
Actual Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Croatia,   Czechia,   France,   Georgia,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries Iceland
 
Administrative Information
NCT Number  ICMJE NCT02914522
Other Study ID Numbers  ICMJE GS-US-418-3898
2016-001392-78 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Galapagos NV
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP