Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

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 Crohn's disease (CD).

Official Title
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A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease

Conditions
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Crohn's Disease

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 a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD Females of childbearing potential must have a negative pregnancy test at Day 1 Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD 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 individual 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 in the protocol Use of prohibited medications as outlined in the study 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 390 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 390 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 for up to 390 weeks | Drug: Placebo<br>* Tablet(s) administered orally once daily<br>|
| Experimental: Filgotinib 200 mg (open-label)<br>Filgotinib 200 mg for up to 390 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 390 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 the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests |  | Up to 390 weeks plus 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in PRO2 Scores | PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency. | Baseline and up to 390 weeks | 
| Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores |  | Baseline and up to 390 weeks |