Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

Study Overview
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Brief Summary
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The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).

Official Title
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A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Filgotinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC Females of childbearing potential must have a negative pregnancy test at Day 1 Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug Key Exclusion Criteria: Known hypersensitivity to the study drug Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined Use of prohibited medications as outlined in the protocol NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Filgotinib 200 mg (blinded dosing)<br>Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks | Drug: Filgotinib<br>* Tablet(s) administered orally once daily<br>* Other names: GLPG0634;Drug: Placebo<br>* Tablet(s) administered orally once daily<br>|
| Experimental: Filgotinib 100 mg (blinded dosing)<br>Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks | Drug: Filgotinib<br>* Tablet(s) administered orally once daily<br>* Other names: GLPG0634;Drug: Placebo<br>* Tablet(s) administered orally once daily<br>|
| Placebo Comparator: Placebo (blinded dosing)<br>Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks | Drug: Placebo<br>* Tablet(s) administered orally once daily<br>|
| Experimental: Filgotinib 200 mg (open-label)<br>Filgotinib 200 mg for up to 336 weeks | Drug: Filgotinib<br>* Tablet(s) administered orally once daily<br>* Other names: GLPG0634;|
| Experimental: Filgotinib 100 mg (open-label)<br>Filgotinib 100 mg for up to 336 weeks | Drug: Filgotinib<br>* Tablet(s) administered orally once daily<br>* Other names: GLPG0634;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests |  | Up to 336 weeks plus 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Components of Mayo Clinic Score (MCS) |  | Baseline and up to 336 weeks |