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

• ClinicalTrials.gov Identifier: NCT03101670
• Recruitment Status: Completed
• First Posted: April 5, 2017
• Last Update Posted: April 23, 2018
• Sponsor: Galapagos NV
• Information provided by (Responsible Party): Galapagos NV

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Psoriatic Arthritis	Drug: filgotinib; Drug: Placebo Oral Tablet	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: March 9, 2017
• Actual Primary Completion Date: March 12, 2018
• Actual Study Completion Date: March 12, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Percentage of subjects who have reached ACR20 response as compared to placebo [ Time Frame: Week 16 ]
   To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients

Secondary Outcome Measures :

1. Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
   To assess the effect of filogotinib on MDA in PsA patients
2. Percentage of subjects who have reached ACR50 response as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
   To assess the effect of filogotinib on PsA as assessed by ACR50 in PsA patients
3. Percentage of subjects who have reached ACR70 response as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
   To assess the effect of filogotinib on PsA as assessed by ACR70 in PsA patients
4. Percentage of subjects achieving DAS28(CRP) score as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
   To assess the effect of filogotinib on PsA as assessed by DAS28 (CRP) in PsA patients
5. Percentage of subjects achieving SDAI response as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
   To assess the effect of filogotinib on PsA as assessed by SDAI response in PsA patients
6. Percentage of subjects achieving CDAI response as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
   To assess the effect of filgotinib on PsA as assessed by CDAI response in PsA patients
7. Percentage of subjects achieving EULAR response as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
   To assess the effect of filogotinib on PsA as assessed by EULAR response in PsA patients
8. Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
   To assess the effect of filogotinib on PsARC in PsA patients
9. Assessment of physician's and patient's global assessment of disease activity as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
   To assess the effect of filogotinib on physician's and patient's global assessment of disease activity in PsA patients
10. Assessment of patient's global assessment of PsA pain intensity in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filogotinib on on PsA pain intensity in PsA patients
11. Assessment of joints for tenderness (68) and swelling (66) in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on joint tenderness and swelling in PsA patients
12. Assessment of CRP in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filogotinib on CRP in PsA patients
13. Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on PASI in PsA patients
14. Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on PASI50 in PsA patients
15. Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the affect of filgotinib on PASI75 in PsA patients
16. Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the affect of filgotinib on PASI90 in PsA patients
17. Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the affect of filgotinib on PASI100 in PsA patients
18. Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the affect of filgotinib on Physician's and patient's global assessment of psoriasis in PsA patients
19. Assessment of mNAPSI in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on mNAPSI in PsA patients
20. Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on NRS in PsA patients
21. Enthesitis as assessed by SPARCC enthesitis index in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients
22. Dactilytis as assessed by LDI in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on Dactilytis in PsA patients
23. Physical function as assessed by HAQ-DI in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on physical function in PsA patients
24. FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients
25. Assessment of SF-36 in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on SF-36 in PsA patients
26. Assessment of Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) in filgotinib treated subjects as compared to placebo [ Time Frame: At each visit from screening until the final follow up visit (week 20) ]
    To assess the effect of filgotinib on PsAID in PsA patients
27. Difference between the number of filgotinib treated subjects and placebo subjects in the number of adverse events [ Time Frame: From screening until the final follow up visit (week 20) ]
    To evaluation safety and tolerability of filgotinib in PsA patients
28. Difference between the number of filgotinib treated subjects and placebo subjects with abnormal clinical laboratory evaluations [ Time Frame: From screening until the final follow up visit (week 20) ]
    To evaluation safety and tolerability of filgotinib in PsA patients
29. Difference between the number of filgotinib treated subjects and placebo subjects with abnormal vital signs [ Time Frame: From screening until the final follow up visit (week 20) ]
    To evaluation safety and tolerability of filgotinib in PsA patients
30. Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination [ Time Frame: From screening until the final follow up visit (week 20) ]
    To evaluation safety and tolerability of filgotinib in PsA patients
31. Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG [ Time Frame: From screening until the final follow up visit (week 20) ]
    To evaluation safety and tolerability of filgotinib in PsA patients
32. Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment [ Time Frame: From screening until the final follow up visit (week 20) ]
    To evaluation safety and tolerability of filgotinib in PsA patients

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Belgium

ULB Hopital Erasme, Service de Rheumatology

Brussels, Belgium

Bulgaria

UMHAT "Kaspela", EOOD

Plovdiv, Bulgaria

MHAT - Ruse, AD

Ruse, Bulgaria

UMHAT "SofiaMed", OOD, Block 1

Sofia, Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

Czechia

CCBR Czech, a.s

Pardubice, Czechia

MEDICAL PLUS s.r.o.

Uherské Hradiště, Czechia

Estonia

Center for Clinical and Basic Research

Tallinn, Estonia

North Estonia Medical Centre Foundation

Tallinn, Estonia

OÜ Innomedica

Tallinn, Estonia

Poland

Twoja Przychodnia-Centrum Medyczne Nowa Sol

Nowa Sól, Poland

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

Poznań, Poland

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

Toruń, Poland

Centrum Medyczne AMED, Warszawa Targowek

Warsaw, Poland

Spain

Hospital Universitario de Fuenlabrada, Servicio de Reumatologia

Fuenlabrada, Spain

Hospital Infanta Luisa, Servicio de Reumatologia

Sevilla, Spain

Ukraine

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

L'viv, 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

Vinnytsya, Ukraine

MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Vinnytsya, Ukraine

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

Vinnytsya, Ukraine

Sponsors and Collaborators

Galapagos NV

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Galapagos NV
• ClinicalTrials.gov Identifier: NCT03101670
• Other Study ID Numbers: GLPG0634-CL-224
• First Posted: April 5, 2017
• Last Update Posted: April 23, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arthritis; Arthritis, Psoriatic; Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases