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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT02914561
• Date of registration: 22/09/2016
• Prospective Registration: Yes
• Primary sponsor: Galapagos NV
• Public title: Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease DIVERSITY1
• Scientific 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
• Date of first enrolment: October 31, 2016
• Target sample size: 1374
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02914561
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, 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, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Galapagos Study Director
• Affiliation: Galapagos NV

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Filgotinib

Drug: Placebo to match filgotinib

Primary Outcome(s)

Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58 [Time Frame: Week 58]

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]

Secondary Outcome(s)

Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845 [Time Frame: Week 4 postdose and Week 10 predose]

Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [Time Frame: Week 26 (predose or postdose) and Week 58 predose]

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

Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58 [Time Frame: Week 58]

Induction Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 10 [Time Frame: Week 10]

Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2 [Time Frame: Week 58]

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 6 Month Corticosteroid-Free Remission by CDAI at Week 58 [Time Frame: Week 58]

Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by CDAI [Time Frame: Week 58]

Secondary ID(s)

2016-001367-36

GS-US-419-3895

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences