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

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 16 Weeks to Subjects With Moderately to Severely Active Psoriatic Arthritis

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).

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: filgotinib; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • ULB Hopital Erasme, Service de Rheumatology
• Bulgaria
  • Plovdiv, Bulgaria
    • UMHAT "Kaspela", EOOD
  • Ruse, Bulgaria
    • MHAT - Ruse, AD
  • Sofia, Bulgaria
    • UMHAT "SofiaMed", OOD, Block 1
  • Sofia, Bulgaria
    • UMHAT "Sv. Ivan Rilski", EAD
• Czechia
  • Pardubice, Czechia
    • CCBR Czech, a.s
  • Uherské Hradiště, Czechia
    • MEDICAL Plus s.r.o.
• Estonia
  • Tallinn, Estonia
    • North Estonia Medical Centre Foundation
  • Tallinn, Estonia
    • OU Innomedica
  • Tallinn, Estonia
    • Center for Clinical and Basic Research
• Poland
  • Nowa Sól, Poland
    • Twoja Przychodnia-Centrum Medyczne Nowa Sol
  • Poznań, Poland
    • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
  • Toruń, Poland
    • Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
  • Warsaw, Poland
    • Centrum Medyczne AMED, Warszawa Targowek
• Spain
  • Fuenlabrada, Spain
    • Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
  • Sevilla, Spain
    • Hospital Infanta Luisa, Servicio de Reumatologia
• Ukraine
  • Kharkiv, Ukraine
    • CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
  • Kiev, 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
  • L'viv, Ukraine
    • CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
  • Poltava, Ukraine
    • M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
  • Ternopil', Ukraine
    • CI of TRC
  • Vinnytsya, Ukraine
    • MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
  • Vinnytsya, Ukraine
    • M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
  • Vinnytsya, Ukraine
    • SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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

Key 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo Oral Tablet; one placebo oral tablet q.d.
Experimental: filgotinib	Drug: filgotinib; one filgotinib oral tablet q.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo	To assess the effect of filogotinib on MDA in PsA patients	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	To assess the effect of filogotinib on PsA as assessed by ACR50 in PsA patients	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	To assess the effect of filogotinib on PsA as assessed by ACR70 in PsA patients	At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving DAS28(CRP) score as compared to placebo	To assess the effect of filogotinib on PsA as assessed by DAS28 (CRP) in PsA patients	At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving SDAI response as compared to placebo	To assess the effect of filogotinib on PsA as assessed by SDAI response in PsA patients	At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving CDAI response as compared to placebo	To assess the effect of filgotinib on PsA as assessed by CDAI response in PsA patients	At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving EULAR response as compared to placebo	To assess the effect of filogotinib on PsA as assessed by EULAR response in PsA patients	At each visit from screening until the final follow up visit (week 20)
Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo	To assess the effect of filogotinib on PsARC in PsA patients	At each visit from screening until the final follow up visit (week 20)
Assessment of physician's and patient's global assessment of disease activity as compared to placebo	To assess the effect of filogotinib on physician's and patient's global assessment of disease activity in PsA patients	At each visit from screening until the final follow up visit (week 20)
Assessment of patient's global assessment of PsA pain intensity in filgotinib treated subjects as compared to placebo	To assess the effect of filogotinib on on PsA pain intensity in PsA patients	At each visit from screening until the final follow up visit (week 20)
Assessment of joints for tenderness (68) and swelling (66) in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on joint tenderness and swelling in PsA patients	At each visit from screening until the final follow up visit (week 20)
Assessment of CRP in filgotinib treated subjects as compared to placebo	To assess the effect of filogotinib on CRP in PsA patients	At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on PASI in PsA patients	At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on PASI50 in PsA patients	At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo	To assess the affect of filgotinib on PASI75 in PsA patients	At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo	To assess the affect of filgotinib on PASI90 in PsA patients	At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo	To assess the affect of filgotinib on PASI100 in PsA patients	At each visit from screening until the final follow up visit (week 20)
Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo	To assess the affect of filgotinib on Physician's and patient's global assessment of psoriasis in PsA patients	At each visit from screening until the final follow up visit (week 20)
Assessment of mNAPSI in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on mNAPSI in PsA patients	At each visit from screening until the final follow up visit (week 20)
Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on NRS in PsA patients	At each visit from screening until the final follow up visit (week 20)
Enthesitis as assessed by SPARCC enthesitis index in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients	At each visit from screening until the final follow up visit (week 20)
Dactilytis as assessed by LDI in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on Dactilytis in PsA patients	At each visit from screening until the final follow up visit (week 20)
Physical function as assessed by HAQ-DI in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on physical function in PsA patients	At each visit from screening until the final follow up visit (week 20)
FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients	At each visit from screening until the final follow up visit (week 20)
Assessment of SF-36 in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on SF-36 in PsA patients	At each visit from screening until the final follow up visit (week 20)
Assessment of Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) in filgotinib treated subjects as compared to placebo	To assess the effect of filgotinib on PsAID in PsA patients	At each visit from screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects in the number of adverse events	To evaluation safety and tolerability of filgotinib in PsA patients	From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal clinical laboratory evaluations	To evaluation safety and tolerability of filgotinib in PsA patients	From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal vital signs	To evaluation safety and tolerability of filgotinib in PsA patients	From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination	To evaluation safety and tolerability of filgotinib in PsA patients	From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG	To evaluation safety and tolerability of filgotinib in PsA patients	From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment	To evaluation safety and tolerability of filgotinib in PsA patients	From screening until the final follow up visit (week 20)

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Pille Harrison, MD, DPhil, MRCP (UK), Galapagos NV

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2017
• Primary Completion (Actual): March 12, 2018
• Study Completion (Actual): March 12, 2018

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: GLPG0634-CL-224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No