NCT03101670

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_2

Geographic Reach
6 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

March 30, 2017

Last Update Submit

April 20, 2018

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects who have reached ACR20 response as compared to placebo

    To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients

    Week 16

Secondary Outcomes (32)

  • Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo

    At each visit from screening until the final follow up visit (week 20)

  • Percentage of subjects who have reached ACR50 response as compared to placebo

    At each visit from screening until the final follow up visit (week 20)

  • Percentage of subjects who have reached ACR70 response as compared to placebo

    At each visit from screening until the final follow up visit (week 20)

  • Percentage of subjects achieving DAS28(CRP) score as compared to placebo

    At each visit from screening until the final follow up visit (week 20)

  • Percentage of subjects achieving SDAI response as compared to placebo

    At each visit from screening until the final follow up visit (week 20)

  • +27 more secondary outcomes

Study Arms (2)

filgotinib

EXPERIMENTAL
Drug: filgotinib

placebo

PLACEBO COMPARATOR
Drug: Placebo Oral Tablet

Interventions

filgotinibDRUG

one filgotinib oral tablet q.d.

filgotinib
Placebo Oral TabletDRUG

one placebo oral tablet q.d.

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

ULB Hopital Erasme, Service de Rheumatology

Brussels, Belgium

Location

UMHAT "Kaspela", EOOD

Plovdiv, Bulgaria

Location

MHAT - Ruse, AD

Rousse, Bulgaria

Location

UMHAT "SofiaMed", OOD, Block 1

Sofia, Bulgaria

Location

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

Location

CCBR Czech, a.s

Pardubice, Czechia

Location

MEDICAL PLUS s.r.o.

Uherské Hradiště, Czechia

Location

Center for Clinical and Basic Research

Tallinn, Estonia

Location

North Estonia Medical Centre Foundation

Tallinn, Estonia

Location

OÜ Innomedica

Tallinn, Estonia

Location

Twoja Przychodnia-Centrum Medyczne Nowa Sol

Nowa Sól, Poland

Location

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

Poznan, Poland

Location

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

Torun, Poland

Location

Centrum Medyczne AMED, Warszawa Targowek

Warsaw, Poland

Location

Hospital Universitario de Fuenlabrada, Servicio de Reumatologia

Fuenlabrada, Spain

Location

Hospital Infanta Luisa, Servicio de Reumatologia

Seville, Spain

Location

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

Kharkiv, Ukraine

Location

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

Kiev, Ukraine

Location

SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh

Kiev, Ukraine

Location

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

Location

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

Poltava, Ukraine

Location

CI of TRC

Ternopil, Ukraine

Location

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

Vinnytsia, Ukraine

Location

MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Vinnytsia, Ukraine

Location

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

Vinnytsia, Ukraine

Location

Related Publications (3)

  • 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.

    PMID: 37945284DERIVED

  • 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.

    PMID: 31624837DERIVED

  • 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.

    PMID: 30360969DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pille Harrison, MD, DPhil, MRCP (UK)

    Galapagos NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 5, 2017

Study Start

March 9, 2017

Primary Completion

March 12, 2018

Study Completion

March 12, 2018

Last Updated

April 23, 2018

Record last verified: 2018-04

Locations

PL(4)ES(2)UA(9)CZ(2)BU(4)BE(1)