Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease (DIVERSITY1)

• ClinicalTrials.gov Identifier: NCT02914561
• Recruitment Status: Completed
• First Posted: September 26, 2016
• Last Update Posted: December 9, 2022
• Sponsor: Galapagos NV
• Collaborator: Gilead Sciences
• Information provided by (Responsible Party): Galapagos NV

Tracking Information

• First Submitted Date: September 22, 2016
• First Posted Date: September 26, 2016
• Last Update Posted Date: December 9, 2022
• Actual Study Start Date: October 31, 2016
• Actual Primary Completion Date: November 11, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 21, 2020)

• Induction Study: Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 [ Time Frame: Week 10 ]
• Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10 [ Time Frame: Week 10 ]
• Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58 [ Time Frame: Week 58 ]
• Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58 [ Time Frame: Week 58 ]

Original Primary Outcome Measures (submitted: September 22, 2016)

• Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10 [ Time Frame: Week 10 ]
• Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10 [ Time Frame: Week 10 ]
• Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 [ Time Frame: Week 58 ]
• Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58 [ Time Frame: Week 58 ]

Current Secondary Outcome Measures (submitted: December 21, 2020)

• Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10 [ Time Frame: Week 10 ]
• Induction Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 10 [ Time Frame: Week 10 ]
• Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ]
• Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 [ Time Frame: Week 58 ]
• Maintenance Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 58 [ Time Frame: Week 58 ]
• Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by CDAI [ Time Frame: Week 58 ]
• Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by CDAI at Week 58 [ Time Frame: Week 58 ]
• Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2 [ Time Frame: Week 58 ]
• Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 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 (submitted: September 22, 2016)

• Induction Study: Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 [ Time Frame: Week 10 ]
• Induction Study: Proportion of Participants Achieving Both Clinical Remission by PRO2 and endoscopic response at Week 10 (Composite Endpoint) [ Time Frame: Week 10 ]
• Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ]
• Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58 [ Time Frame: Week 58 ]
• Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2 at Weeks 10 and 58 [ Time Frame: Weeks 10 and 58 ]
• Maintenance Study: Proportion of Participants Achieving Both Clinical Remission by PRO2 and Endoscopic Response at Week 58 (Composite Endpoint) [ Time Frame: Week 58 ]
• Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 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: Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
• Official Title: Combined Phase 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 Crohn's Disease

Brief Summary

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) 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-419-3896).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Crohn's Disease

Intervention

• 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

• 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 the Maintenance Study and receive filgotinib and/or placebo for 48 weeks.
  Interventions:

  • Drug: Filgotinib
  • Drug: Placebo to match filgotinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 12, 2021): 1374
• Original Estimated Enrollment (submitted: September 22, 2016): 1320
• Actual Study Completion Date: November 11, 2022
• Actual Primary Completion Date: November 11, 2022 (Final data collection date for primary outcome measure)

Eligibility 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 CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
• Moderately to severely active CD
• Cohort A (Biologic Naïve): 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 and immunomodulators
• Cohort A (Biologic Experienced): 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) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
• Cohort B (Biologic Experienced): 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): TNFa antagonists, vedolizumab, and ustekinumab

Key Exclusion Criteria:

• Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
• Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
• Active tuberculosis (TB) or history of latent TB that has not been treated
• Use of any prohibited concomitant medications as described in the study protocol

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
• Removed Location Countries: Czech Republic, Mexico

Administrative Information

• NCT Number: NCT02914561
• Other Study ID Numbers: GS-US-419-3895; 2016-001367-36 ( 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: Not Provided
• Current Responsible Party: Galapagos NV
• Original Responsible Party: Gilead Sciences
• Current Study Sponsor: Galapagos NV
• Original Study Sponsor: Gilead Sciences
• Collaborators: Gilead Sciences

Investigators

• Study Director: Galapagos Study Director; Galapagos NV

• PRS Account: Galapagos NV
• Verification Date: December 2022