Filgotinib

Generic Name: Filgotinib

Brand Names: Jyseleca

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₃N_₅O_₃S

CAS Number: 1206161-97-8

Unique Ingredient Identifier: 3XVL385Q0M

Background: Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, and inflammatory disease that causes synovial joint symptoms and can limit range of motion in severe cases. The disease is associated with extra-articular manifestations, progressive disability, and comorbidities including cardiovascular disease and mental disorders. 50-70% of patients with RA are...

Indication: Filgotinib is indicated for the treatment of active moderate to severe rheumatoid arthritis alone or in combination with methotrexate. Filgotinib is currently reserved for patients who are unable to tolerate or who have not responded adequately to one or more disease-modifying anti-rheumatic drugs (DMARDS).
...

Associated Conditions: Active, Moderate to Severe Rheumatoid Arthritis, Moderately to Severely Active Ulcerative Colitis

Associated Therapies: -

Clinical Trials

Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis

Phase 2

Terminated

Conditions: Noninfectious Uveitis

Interventions: Drug: Filgotinib
Drug: Placebo to match filgotinib
Drug: Prednisone

First Posted Date: 2017-07-05

Last Posted Date: 2022-01-21

Lead Sponsor: Gilead Sciences

Target Recruit Count: 74

Registration Number: NCT03207815

Locations: 🇺🇸
Metropolitan Eye Research and Surgery Institute, Palisades Park, New Jersey, United States
🇺🇸
Texas Retina Associates - Fort Worth, Fort Worth, Texas, United States
🇺🇸
Colorado Retina Associates PC, Golden, Colorado, United States

and more 21 locations

Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease

Phase 2

Terminated

Conditions: Inflammatory Bowel Disease

Interventions: Drug: Placebo
Drug: Filgotinib
Drug: Standard of Care

First Posted Date: 2017-06-28

Last Posted Date: 2024-10-09

Lead Sponsor: Galapagos NV

Target Recruit Count: 139

Registration Number: NCT03201445

Locations: 🇺🇸
University of Miami Crohn's and Colitis Center, Miami, Florida, United States
🇺🇸
One Health Research Clinic, Inc, Norcross, Georgia, United States
🇺🇸
Texas Clinical Research Institute, Arlington, Texas, United States

and more 53 locations

Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

Phase 2

Completed

Conditions: Cutaneous Lupus Erythematosus

Interventions: Drug: Lanraplenib
Drug: Filgotinib
Drug: Lanraplenib placebo
Drug: Filgotinib placebo

First Posted Date: 2017-04-28

Last Posted Date: 2020-06-09

Lead Sponsor: Gilead Sciences

Target Recruit Count: 47

Registration Number: NCT03134222

Locations: 🇨🇦
K.Papp Clinical Research, Waterloo, Canada
🇨🇦
Dermatology Ottawa Research Centre, Ottawa, Canada
🇺🇸
St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare, Fullerton, California, United States

and more 13 locations

A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis

Phase 2

Completed

Conditions: Ankylosing Spondylitis

Interventions: Drug: Placebo Oral Tablet
Drug: filgotinib

First Posted Date: 2017-04-17

Last Posted Date: 2018-08-13

Lead Sponsor: Galapagos NV

Target Recruit Count: 116

Registration Number: NCT03117270

Locations: 🇵🇱
Centrum Medyczne SILESIANA Sp z oo, Bytom, Poland
🇺🇦
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh, Kiev, Ukraine
🇺🇦
CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology, L'viv, Ukraine

and more 27 locations

A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis

Phase 2

Completed

Conditions: Psoriatic Arthritis

Interventions: Drug: Placebo Oral Tablet
Drug: filgotinib

First Posted Date: 2017-04-05

Last Posted Date: 2018-04-23

Lead Sponsor: Galapagos NV

Target Recruit Count: 131

Registration Number: NCT03101670

Locations: 🇪🇸
Hospital Infanta Luisa, Servicio de Reumatologia, Sevilla, Spain
🇧🇬
MHAT - Ruse, AD, Ruse, Bulgaria
🇨🇿
CCBR Czech, a.s, Pardubice, Czechia

and more 22 locations

Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

Phase 2

Completed

Conditions: Sjogren's Syndrome

Interventions: Drug: Lanraplenib
Drug: Filgotinib
Drug: Tirabrutinib
Drug: Lanraplenib placebo
Drug: Filgotinib placebo
Drug: Tirabrutinib placebo

First Posted Date: 2017-04-04

Last Posted Date: 2020-10-23

Lead Sponsor: Gilead Sciences

Target Recruit Count: 152

Registration Number: NCT03100942

Locations: 🇺🇸
Clinical Research of West Florida, Inc., Clearwater, Florida, United States
🇺🇸
Center for Rheumatology Immunology and Arthritis, Fort Lauderdale, Florida, United States
🇺🇸
IRIS Research and Development, LLC, Plantation, Florida, United States

and more 49 locations

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

Phase 2

Completed

Conditions: Fistulizing Crohn's Disease

Interventions: Drug: Filgotinib
Drug: Placebo to match filgotinib

First Posted Date: 2017-03-13

Last Posted Date: 2022-04-08

Lead Sponsor: Gilead Sciences

Target Recruit Count: 57

Registration Number: NCT03077412

Locations: 🇺🇸
Gastro One, Germantown, Tennessee, United States
🇺🇸
DHAT Research Institute, Garland, Texas, United States
🇺🇸
Texas Digestive Disease Consultants, Southlake, Texas, United States

and more 24 locations

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

Phase 2

Completed

Conditions: Small Bowel Crohn's Disease

Interventions: Drug: Filgotinib
Drug: Placebo to match filgotinib

First Posted Date: 2017-02-08

Last Posted Date: 2021-08-23

Lead Sponsor: Gilead Sciences

Target Recruit Count: 78

Registration Number: NCT03046056

Locations: 🇺🇸
Gastro One, Germantown, Tennessee, United States
🇦🇹
Medical University of Innsbruck, Department of Internal Medicine I, Innsbruck, Austria
🇺🇸
University of Miami Crohn's and Colitis Center, Miami, Florida, United States

and more 35 locations

Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis

Phase 3

Active, not recruiting

Conditions: Rheumatoid Arthritis

Interventions: Drug: Filgotinib
Drug: Placebo to match filgotinib

First Posted Date: 2017-01-19

Last Posted Date: 2024-10-30

Lead Sponsor: Alfasigma S.p.A.

Target Recruit Count: 2731

Registration Number: NCT03025308

Locations: 🇺🇸
Rheumatology Associates of North Alabama, PC, Huntsville, Alabama, United States
🇺🇸
Arthrocare, Arthritis Care & Research PC, Gilbert, Arizona, United States
🇺🇸
Arizona Arthritis & Rheumatology Associates, P.C., Tucson, Arizona, United States

and more 338 locations

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

Phase 3

Completed

Conditions: Crohn's Disease

Interventions: Drug: Filgotinib
Other: Placebo

First Posted Date: 2016-09-26

Last Posted Date: 2023-12-18

Lead Sponsor: Galapagos NV

Target Recruit Count: 1372

Registration Number: NCT02914561

Locations: 🇺🇸
Massachusetts General Hospital - Crohn's and Colitis Center, Boston, Massachusetts, United States
🇺🇸
Kelsey-Seybold Clinic, Houston, Texas, United States
🇺🇸
The University of Texas Health Science Center at Houston, Houston, Texas, United States

and more 509 locations

Drug Development Updates

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