Filgotinib: Clinical Trials

21 completed, 8 terminated, 5 recruiting, 4 active not recruiting. 17 Phase 3, 14 Phase 2, 4 Phase 1, 3 Phase 4.

By phase and status

Phase	Trials	Status
Phase 3	17	Completed 7, Terminated 4, Recruiting 3, Withdrawn 2, Active not recruiting 1
Phase 2	14	Completed 10, Terminated 3, Recruiting 1
Phase 1	4	Completed 3, Terminated 1
Phase 4	3	Unknown 2, Recruiting 1

Follow Filgotinib: new trials by email Literature Review of Filgotinib trials Research Report on Filgotinib

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents Filgotinib - Polyarticular Course Juvenile Idiopathic Arthritis	Phase 3	Recruiting	Alfasigma S.p.A.	65	2026-05-21	2026-06-12
OLE Study With Filgotinib in JIA Filgotinib - Juvenile Idiopathic Arthritis (JIA)	Phase 3	Recruiting	Alfasigma S.p.A.	80	2026-04-20	2026-08-10
Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population Non-Interventional Study - Ulcerative Colitis		Active not recruiting	Pfizer	4000	2026-04-01	2026-10-15
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Filgotinib - Ulcerative Colitis	Phase 3	Recruiting	Alfasigma S.p.A.	80	2025-09-29	2026-10-20
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA) Filgotinib, Adalimumab - Rheumatoid Arthritis	Phase 4	Unknown	Universita di Verona	30	2024-07-15	2024-08-01
Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA) Filgotinib - Juvenile Idiopathic Arthritis	Phase 1	Terminated	Alfasigma S.p.A.	9	2024-05-13	2026-07-15
Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases Filgotinib - Behcet's Disease, Idiopathic Inflammatory Myopathies	Phase 2	Recruiting	UMC Utrecht	60	2024-03-12	2026-05-12
Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects Filgotinib - Bioavailability	Phase 1	Completed	Lakefront Biotherapeutics NV	12	2023-09-22	2023-11-29
Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) Filgotinib - Ulcerative Colitis		Active not recruiting	Alfasigma S.p.A.	509	2023-06-12	2025-12-24
A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis Filgotinib, Placebo - Axial Spondyloarthritis	Phase 3	Active not recruiting	Alfasigma S.p.A.	495	2023-04-05	2025-12-04
Januse Kinase Inhibition With Filgotinib to Silence Autoreactive B Cells in Rheumatoid Arthritis Filgotinib, Adalimumab - Rheumatoid Arthritis	Phase 4	Unknown	Leiden University Medical Center	40	2022-10-01	2022-08-16
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission Filgotinib, Placebo - Ulcerative Colitis	Phase 3	Terminated	Lakefront Biotherapeutics NV	22	2022-07-26	2024-10-04
Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France Filgotinib - Rheumatoid Arthritis		Completed	Alfasigma S.p.A.	155	2022-05-03	2026-05-22
Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH) Filgotinib, Anti-Tumor Necrosis Factor Alpha Drug (Product), 50 patients will have a Free Choice between Filgotinib and anti TNF - Rheumatoid Arthritis	Phase 4	Recruiting	R.Bos	100	2021-05-12	2025-08-08
Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis Filgotinib - Rheumatoid Arthritis		Active not recruiting	Alfasigma S.p.A.	1304	2021-05-11	2026-10-28
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy Filgotinib, Placebo to Match Filgotinib - Ankylosing Spondylitis	Phase 3	Withdrawn	Gilead Sciences		2020-12-01	2021-01-11
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy Filgotinib, Placebo to Match Filgotinib - Ankylosing Spondylitis	Phase 3	Withdrawn	Gilead Sciences		2020-12-01	2021-01-11
Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants Atorvastatin, Pravastatin, Rosuvastatin - Rheumatoid Arthritis	Phase 1	Completed	Gilead Sciences	27	2020-11-04	2022-06-14
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy Filgotinib, Adalimumab, Placebo to match filgotinib - Psoriatic Arthritis	Phase 3	Terminated	Gilead Sciences	67	2019-12-03	2022-05-16
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy Filgotinib, Placebo to match filgotinib - Psoriatic Arthritis	Phase 3	Terminated	Gilead Sciences	106	2019-11-13	2022-03-18

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Conditions studied

Arthritis, Rheumatoid (14)  ·  Colitis, Ulcerative (6)  ·  Arthritis, Psoriatic (5)  ·  Spondylitis, Ankylosing (4)  ·  Arthritis, Juvenile (3)  ·  Crohn Disease (2)  ·  Axial Spondyloarthritis (1)  ·  Behcet Syndrome (1)  ·  Immunoglobulin G4-Related Disease (1)  ·  Inflammatory Bowel Diseases (1)  ·  Lupus Erythematosus, Cutaneous (1)  ·  Myositis (1)  ·  Sjogren's Syndrome (1)

Sponsors

Gilead Sciences (17)  ·  Alfasigma S.p.A. (10)  ·  Lakefront Biotherapeutics NV (10)  ·  Leiden University Medical Center (1)  ·  Pfizer (1)  ·  R.Bos (1)  ·  UMC Utrecht (1)  ·  Universita di Verona (1)

Countries

Spain (24)  ·  Poland (23)  ·  Germany (22)  ·  United Kingdom (22)  ·  United States (22)  ·  Belgium (21)  ·  Czechia (19)  ·  France (17)  ·  Hungary (16)  ·  Italy (16)  ·  Bulgaria (15)  ·  Ukraine (15)  ·  Canada (14)  ·  Australia (13)  ·  New Zealand (12)

Top investigators

Pille Harrison, MD, DPhil, MRCP (UK) (2)  ·  Catherine Vincent (1)  ·  Jaap M van Laar, Prof. dr. (1)  ·  Reinhard Bos, MD PhD (1)  ·  Tom WJ Huizinga, MD PhD (1)  ·  Vijay Rajendran, MD (1)

Results publications

PMID 36205910, PMID 37747626, PMID 34980223, PMID 38057656, PMID 38985247, PMID 35614292, PMID 36327094, PMID 37137672, PMID 37540206, PMID 37718932, PMID 42536126, PMID 30360969, PMID 30360970, PMID 31334793, PMID 31624837, PMID 33177349, PMID 33274687, PMID 33380521, PMID 33452004, PMID 33504485, PMID 33526618, PMID 34090625, PMID 34352069, PMID 34385364, PMID 34498056, PMID 34647992, PMID 35377447, PMID 36006011, PMID 36756874, PMID 36928705, PMID 36946138, PMID 37172783, PMID 37490202, PMID 37945284, PMID 38019901, PMID 38366672, PMID 39023880, PMID 39086130, PMID 39331638, PMID 39452892, PMID 39506562, PMID 39592547, PMID 39637881, PMID 39656830, PMID 39884731, PMID 39915014, PMID 40379541, PMID 41039829, PMID 41569324, PMID 41841789

NIH funding

2016 (12), 2017 (4), 2019 (4), 2018 (1), 2023 (1), 2025 (1)