CLINICAL TRIALS PROFILE FOR FILGOTINIB

Clinical Trials for Filgotinib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02065700 ↗	Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients	Active, not recruiting	Gilead Sciences	Phase 2	The primary objective of the study is to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis. Participants will be enrolled in this open-label long-term follow-up study after they have completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204 (DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants will also be examined for long-term effects of filgotinib administration on disease activity (efficacy), subjects' disability, fatigue, and quality of life.
NCT02065700 ↗	Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients	Active, not recruiting	Galapagos NV	Phase 2	The primary objective of the study is to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis. Participants will be enrolled in this open-label long-term follow-up study after they have completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204 (DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants will also be examined for long-term effects of filgotinib administration on disease activity (efficacy), subjects' disability, fatigue, and quality of life.
NCT02873936 ↗	Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment	Completed	Galapagos NV	Phase 3	The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
NCT02873936 ↗	Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment	Completed	Gilead Sciences	Phase 3	The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
NCT02885181 ↗	Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate	Completed	Gilead Sciences	Phase 2	The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.
NCT02886728 ↗	Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy	Completed	Galapagos NV	Phase 3	The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).

Clinical Trial Conditions for Filgotinib

Condition Name

Condition Name for
Intervention	Trials
Rheumatoid Arthritis	12
Ulcerative Colitis	6
Psoriatic Arthritis	5
Ankylosing Spondylitis	4

Condition MeSH

Condition MeSH for
Intervention	Trials
Arthritis	16
Arthritis, Rheumatoid	12
Colitis, Ulcerative	6
Crohn Disease	5

Clinical Trial Locations for Filgotinib

Trials by Country

Trials by Country for
Location	Trials
United States	337
Australia	36
Canada	21
Hungary	21
Poland	20

Trials by US State

Trials by US State for
Location	Trials
Florida	20
Texas	20
North Carolina	16
California	16
Michigan	15

Clinical Trial Progress for Filgotinib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	15
Phase 2	13

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	15
Active, not recruiting	6
Terminated	4

Clinical Trial Sponsors for Filgotinib

Sponsor Name

Sponsor Name for
Sponsor	Trials
Galapagos NV	29
Gilead Sciences	26
Leiden University Medical Center	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	56
Other	7