Clinical Trials

Filgotinib is evaluated in numerous clinical trials spanning Phase 1 through Phase 4 development, focusing on pharmacokinetic assessments and autoimmune and inflammatory conditions including rheumatoid arthritis, ulcerative colitis, axial spondyloarthritis, ankylosing spondylitis, fistulizing Crohn's disease, and juvenile idiopathic arthritis. Sponsored by biopharmaceutical companies such as Galapagos NV, Gilead Sciences, and Alfasigma S.p.A., alongside academic institutions including NHS Greater Glasgow and Clyde and the University of Amsterdam, these studies encompass Phase 1 pediatric trials and Phase 3 efficacy evaluations. Recruitment statuses across these investigations range from actively recruiting to completed and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07576452 NOT_YET_RECRUITING
Ulcerative Colitis (UC)
University Hospital, Clermont-Ferrand
 2026-06-01 PHASE4
NCT06687551 RECRUITING
Rheumatoid Arthritis (RA
University Hospital, Toulouse
 2025-06-06 PHASE4
NCT06865417 RECRUITING
Ulcerative Colitis
Alfasigma S.p.A.
 2025-09-29 PHASE3
NCT07553182 RECRUITING
Juvenile Idiopathic Arthritis (JIA)
Alfasigma S.p.A.
 2026-04-20 PHASE3
NCT06964113 ACTIVE_NOT_RECRUITING
Ulcerative Colitis
Eisai Korea Inc.
 2025-06-11 PHASE4
NCT07554495 RECRUITING
Polyarticular Course Juvenile Idiopathic Arthritis
Alfasigma S.p.A.
 2026-05-21 PHASE3
NCT06285539 RECRUITING
Behcet's Disease; Idiopathic Inflammatory Myopathies; IgG4-related Disease
UMC Utrecht
 2024-03-12 PHASE2
NCT02914535 ACTIVE_NOT_RECRUITING
Ulcerative Colitis
Alfasigma S.p.A.
 2017-02-23 PHASE3
NCT06222034 TERMINATED
Juvenile Idiopathic Arthritis
Alfasigma S.p.A.
 2024-05-13 PHASE1
NCT06625242 COMPLETED
Rheumatoid Arthritis
Eisai Korea Inc.
 2024-10-22 PHASE4
NCT04985435 RECRUITING
Rheumatoid Arthritis
R.Bos
 2021-05-12 PHASE4
NCT06527534 UNKNOWN
Rheumatoid Arthritis
Universita di Verona
 2024-07-15 PHASE4
NCT03025308 COMPLETED
Rheumatoid Arthritis
Alfasigma S.p.A.
 2017-02-28 PHASE3
NCT05502731 UNKNOWN
Rheumatoid Arthritis
Leiden University Medical Center
 2022-10 PHASE4
NCT05785611 ACTIVE_NOT_RECRUITING
Axial Spondyloarthritis
Alfasigma S.p.A.
 2023-04-05 PHASE3
NCT06222034 Recruiting
Juvenile Idiopathic Arthritis
Galapagos NV
 2024-04 Phase 1
NCT06043739 COMPLETED
Bioavailability
Lakefront Biotherapeutics NV
 2023-09-22 PHASE1
NCT05479058 TERMINATED
Ulcerative Colitis
Lakefront Biotherapeutics NV
 2022-07-26 PHASE3
NCT06043739 Completed
Bioavailability
Galapagos NV
 2023-09-22 Phase 1
NCT02914600 TERMINATED
Crohn's Disease
Lakefront Biotherapeutics NV
 2017-03-17 PHASE3
NCT05697159 Recruiting
Rheumatoid Arthritis|Sickness Behavior|Inflammatory Disease|Autoimmune|Pain Chronic
NHS Greater Glasgow and Clyde|Galapagos NV
 2023-08-22 --
NCT05090410 UNKNOWN
Rheumatoid Arthritis; JAK Inhibitor; IL-6 Inhibitor; Musculoskeletal Ultrasound; Biomarker
Atsushi Kawakami
 2021-03-03 PHASE3
NCT02065700 COMPLETED
Rheumatoid Arthritis
Lakefront Biotherapeutics NV
 2014-02-25 PHASE2
NCT04483687 WITHDRAWN
Ankylosing Spondylitis
Gilead Sciences
 2020-12 PHASE3
NCT02914561 COMPLETED
Crohn's Disease
Lakefront Biotherapeutics NV
 2016-10-31 PHASE3
NCT04483700 WITHDRAWN
Ankylosing Spondylitis
Gilead Sciences
 2020-12 PHASE3
NCT05653791 Active not recruiting
Ulcerative Colitis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|Galapagos NV
 2022-10-01 --
NCT03320876 TERMINATED
Psoriatic Arthritis
Lakefront Biotherapeutics NV
 2017-07-26 PHASE2
NCT03077412 COMPLETED
Fistulizing Crohn's Disease
Gilead Sciences
 2017-04-06 PHASE2
NCT04115748 TERMINATED
Psoriatic Arthritis
Gilead Sciences
 2019-12-03 PHASE3
NCT04608344 COMPLETED
Rheumatoid Arthritis
Gilead Sciences
 2020-11-04 PHASE1
NCT04115839 TERMINATED
Psoriatic Arthritis
Gilead Sciences
 2019-11-13 PHASE3
NCT03207815 TERMINATED
Noninfectious Uveitis
Gilead Sciences
 2017-07-26 PHASE2
NCT03201445 TERMINATED
Inflammatory Bowel Disease
Lakefront Biotherapeutics NV
 2017-07-11 PHASE2
NCT03926195 COMPLETED
Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Non-Radiographical Axial Spondyloarthritis
Lakefront Biotherapeutics NV
 2019-05-28 PHASE2
NCT03046056 COMPLETED
Small Bowel Crohn's Disease
Gilead Sciences
 2017-04-11 PHASE2
NCT02914522 COMPLETED
Ulcerative Colitis
Gilead Sciences
 2016-11-14 PHASE3
NCT03285711 COMPLETED
Lupus Membranous Nephropathy
Gilead Sciences
 2017-10-06 PHASE2
NCT03134222 COMPLETED
Cutaneous Lupus Erythematosus
Gilead Sciences
 2017-05-24 PHASE2
NCT03100942 COMPLETED
Sjogren's Syndrome
Gilead Sciences
 2017-05-01 PHASE2
NCT02886728 COMPLETED
Rheumatoid Arthritis
Gilead Sciences
 2016-08-08 PHASE3
NCT03417778 COMPLETED
Rheumatoid Arthritis
Gilead Sciences
 2018-04-03 PHASE1
NCT02889796 COMPLETED
Rheumatoid Arthritis
Gilead Sciences
 2016-08-30 PHASE3
NCT03117270 COMPLETED
Ankylosing Spondylitis
Lakefront Biotherapeutics NV
 2017-03-07 PHASE2
NCT03417778 Completed
Rheumatoid Arthritis
Gilead Sciences|Galapagos NV
 2018-04-03 Phase 1
NCT02873936 COMPLETED
Rheumatoid Arthritis
Gilead Sciences
 2016-07-27 PHASE3
NCT03101670 COMPLETED
Psoriatic Arthritis
Lakefront Biotherapeutics NV
 2017-03-09 PHASE2
NCT02885181 COMPLETED
Rheumatoid Arthritis
Gilead Sciences
 2016-09-21 PHASE2
NCT02048618 COMPLETED
Crohn's Disease
Lakefront Biotherapeutics NV
 2014-02 PHASE2
NCT01894516 COMPLETED
Rheumatoid Arthritis
Lakefront Biotherapeutics NV
 2013-10-08 PHASE2
NCT01888874 COMPLETED
Rheumatoid Arthritis
Lakefront Biotherapeutics NV
 2013-07-17 PHASE2
NCT02162355 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2014-06 PHASE1
NCT02084199 COMPLETED
Renal Impairment
Lakefront Biotherapeutics NV
 2014-03 PHASE1
NCT01915667 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2013-07 PHASE1
NCT01820806 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2013-03 PHASE1
NCT01798979 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2013-02 PHASE1
NCT01668641 COMPLETED
Rheumatoid Arthritis
Lakefront Biotherapeutics NV
 2012-05 PHASE2
NCT01665924 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2012-07 PHASE1
NCT01384422 COMPLETED
Rheumatoid Arthritis
Lakefront Biotherapeutics NV
 2011-06 PHASE2
NCT01419990 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2011-08 PHASE1
NCT01179581 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2010-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-13)

Check the Filgotinib (GLPG0634) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Filgotinib selectively binds to and inhibits Janus kinase 1 (JAK1), thereby suppressing ATP binding and preventing downstream STAT transcription factor phosphorylation within pro-inflammatory cytokine signaling pathways. This targeted biochemical inhibition reduces immune cell activation and inflammatory cascade signaling, ultimately mitigating chronic tissue inflammation and systemic disease severity in autoimmune conditions such as rheumatoid arthritis and ulcerative colitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.