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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02914522
• Date of registration: 22/09/2016
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis SELECTION1
• Scientific 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
• Date of first enrolment: November 14, 2016
• Target sample size: 1351
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02914522
• 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, 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, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

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 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.



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

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Filgotinib

Drug: Placebo to match filgotinib

Primary Outcome(s)

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]

Secondary Outcome(s)

Induction Study: Proportion of Participants Achieving MCS Remission at Week 10 [Time Frame: Week 10]

Maintenance Study: Proportion of Participants Achieving MCS Remission at Week 58 [Time Frame: Week 58]

Induction Study: Proportion of participants achieving MCS remission (alternative definition) at Week 10 [Time Frame: Week 10]

Induction Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10 [Time Frame: Week 10]

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: Proportion of Participants Achieving Remission Based on Components of MCS at Weeks 10 and 58 [Time Frame: Weeks 10 and 58]

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: 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 6-Month Corticosteroid-Free Remission Based on Components of MCS at Week 58 [Time Frame: Week 58]

Induction Study: Proportion of Participants Achieving Histologic Remission at Week 10 [Time Frame: Week 10]

Secondary ID(s)

GS-US-418-3898

2016-001392-78

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Galapagos NV