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

NCT ID: NCT03101670

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2018-03-12

Brief Summary

This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 weeks (from Screening visit to Follow-up visit).

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

filgotinib

Group Type: EXPERIMENTAL

filgotinib

Intervention Type: DRUG

one filgotinib oral tablet q.d.

placebo

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

one placebo oral tablet q.d.

Interventions

filgotinib

one filgotinib oral tablet q.d.

Intervention Type: DRUG

Placebo Oral Tablet

one placebo oral tablet q.d.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
• Diagnosis of psoriatic arthritis meeting Classification Criteria for Psoriatic Arthritis (CASPAR)
• Have active psoriatic arthritis defined as ≥5 swollen joints (from a 66 swollen joint count [SJC]) and ≥5 tender joints (from a 68 tender joint count [TJC]) at Screening and Baseline (measurable dactylitis of a digit counts as a single swollen joint and if tender, then also a single tender joint).
• Have had a history of documented plaque psoriasis or currently active plaque psoriasis
• If using cDMARD therapy, subjects must have been on it for 12 weeks prior to screening, with a stable dose (including stable route of administration) for at least 4 weeks prior to baseline.
• If using non-drug therapies (including physical therapies), thse should be kept sable during screening
• Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol

Exclusion Criteria

• Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
• Prior use of more than one TNF inhibitor, at any time.
• Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to Baseline;
• Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
• Use of more than 1 NSAID or cyclooxygenase-2 (COX-2) inhibitor.
• Have undergone surgical treatment for psoriatic arthritis including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to screening
• Presence of very poor functional status or unable to perform self-care.
• Administration of a live or attenuated vaccine within 12 weeks prior to baseline

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pille Harrison, MD, DPhil, MRCP (UK)

Role: STUDY_DIRECTOR

Galapagos NV

Locations

ULB Hopital Erasme, Service de Rheumatology

Brussels, , Belgium

UMHAT "Kaspela", EOOD

Plovdiv, , Bulgaria

MHAT - Ruse, AD

Rousse, , Bulgaria

UMHAT "SofiaMed", OOD, Block 1

Sofia, , Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, , Bulgaria

CCBR Czech, a.s

Pardubice, , Czechia

MEDICAL PLUS s.r.o.

Uherské Hradiště, , Czechia

Center for Clinical and Basic Research

Tallinn, , Estonia

North Estonia Medical Centre Foundation

Tallinn, , Estonia

OÜ Innomedica

Tallinn, , Estonia

Twoja Przychodnia-Centrum Medyczne Nowa Sol

Nowa Sól, , Poland

Ai Centrum Medyczne sp. z o.o. sp.k.

Poznan, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna

Torun, , Poland

Centrum Medyczne AMED, Warszawa Targowek

Warsaw, , Poland

Hospital Universitario de Fuenlabrada, Servicio de Reumatologia

Fuenlabrada, , Spain

Hospital Infanta Luisa, Servicio de Reumatologia

Seville, , Spain

CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics

Kharkiv, , Ukraine

CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy

Kiev, , Ukraine

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

Lviv, , Ukraine

M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy

Poltava, , Ukraine

CI of TRC

Ternopil, , Ukraine

M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1

Vinnytsia, , Ukraine

MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Vinnytsia, , Ukraine

SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy

Vinnytsia, , Ukraine

Countries

Belgium; Bulgaria; Czechia; Estonia; Poland; Spain; Ukraine

References

Chandran V, Malkov VA, Ito KL, Liu Y, Vestergaard L, Yoon OK, Liu J, Trivedi M, Hertz A, Gladman D. Pharmacodynamic effects of filgotinib treatment driving clinical improvement in patients with active psoriatic arthritis enrolled in the EQUATOR trial. RMD Open. 2023 Nov;9(4):e003550. doi: 10.1136/rmdopen-2023-003550.

Reference Type: DERIVED

PMID: 37945284 (View on PubMed)

Orbai AM, Ogdie A, Gossec L, Tillett W, Leung YY, Gao J, Trivedi M, Tasset C, Meuleners L, Besuyen R, Hendrikx T, Coates LC. Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR). Rheumatology (Oxford). 2020 Jul 1;59(7):1495-1504. doi: 10.1093/rheumatology/kez408.

Reference Type: DERIVED

PMID: 31624837 (View on PubMed)

Mease P, Coates LC, Helliwell PS, Stanislavchuk M, Rychlewska-Hanczewska A, Dudek A, Abi-Saab W, Tasset C, Meuleners L, Harrison P, Besuyen R, Van der Aa A, Mozaffarian N, Greer JM, Kunder R, Van den Bosch F, Gladman DD. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): results from a randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Dec 1;392(10162):2367-2377. doi: 10.1016/S0140-6736(18)32483-8. Epub 2018 Oct 22.

Reference Type: DERIVED

PMID: 30360969 (View on PubMed)

Other Identifiers

GLPG0634-CL-224

Identifier Type: -

Identifier Source: org_study_id