Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis (SELECTION)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: PTM filgotinib; Drug: Filgotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02914522

GS-US-418-3898

2016-001392-78 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to evaluate the 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 met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

Enrollment: 1,351 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,351 participants in 11 patient groups, including a placebo group

Induction Study (Cohort A): Filgotinib 200 mg

Experimental group

Description:

Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.

Treatment:

Drug: PTM filgotinib

Drug: Filgotinib

Induction Study (Cohort A): Filgotinib 100 mg

Experimental group

Description:

Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

Treatment:

Drug: PTM filgotinib

Drug: Filgotinib

Induction Study (Cohort A): Placebo

Placebo Comparator group

Description:

Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

Treatment:

Drug: PTM filgotinib

Induction Study (Cohort B): Filgotinib 200 mg

Experimental group

Description:

Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

Treatment:

Drug: PTM filgotinib

Drug: Filgotinib

Induction Study (Cohort B): Filgotinib 100 mg

Experimental group

Description:

Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

Treatment:

Drug: PTM filgotinib

Drug: Filgotinib

Induction Study (Cohort B): Placebo

Placebo Comparator group

Description:

Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

Treatment:

Drug: PTM filgotinib

Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg

Experimental group

Description:

Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58).

Treatment:

Drug: PTM filgotinib

Drug: Filgotinib

Maintenance Study: Placebo From Induction Filgotinib 200 mg

Placebo Comparator group

Description:

Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

Treatment:

Drug: PTM filgotinib

Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg

Experimental group

Description:

Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58).

Treatment:

Drug: PTM filgotinib

Drug: Filgotinib

Maintenance Study: Placebo From Induction Filgotinib 100 mg

Placebo Comparator group

Description:

Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

Treatment:

Drug: PTM filgotinib

Maintenance Study: Placebo From Induction Placebo

Placebo Comparator group

Description:

Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58).

Treatment:

Drug: PTM filgotinib