EQUATOR: A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis
Study Details
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 |
|---|---|---|
|
Phase 2 |
Study Design
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
- Percentage of subjects who have reached ACR20 response as compared to placebo [Week 16]
To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients
Secondary Outcome Measures
- 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)]
To assess the effect of filogotinib on MDA in PsA patients
- 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)]
To assess the effect of filogotinib on PsA as assessed by ACR50 in PsA patients
- 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)]
To assess the effect of filogotinib on PsA as assessed by ACR70 in PsA patients
- Percentage of subjects achieving DAS28(CRP) score as compared to placebo [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
- Percentage of subjects achieving SDAI response as compared to placebo [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
- Percentage of subjects achieving CDAI response as compared to placebo [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
- Percentage of subjects achieving EULAR response as compared to placebo [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
- Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the effect of filogotinib on PsARC in PsA patients
- Assessment of physician's and patient's global assessment of disease activity as compared to placebo [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
- Assessment of patient's global assessment of PsA pain intensity in filgotinib treated subjects as compared to placebo [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
- Assessment of joints for tenderness (68) and swelling (66) in filgotinib treated subjects as compared to placebo [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
- Assessment of CRP in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the effect of filogotinib on CRP in PsA patients
- Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the effect of filgotinib on PASI in PsA patients
- Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the effect of filgotinib on PASI50 in PsA patients
- Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the affect of filgotinib on PASI75 in PsA patients
- Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the affect of filgotinib on PASI90 in PsA patients
- Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the affect of filgotinib on PASI100 in PsA patients
- Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo [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
- Assessment of mNAPSI in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the effect of filgotinib on mNAPSI in PsA patients
- Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the effect of filgotinib on NRS in PsA patients
- Enthesitis as assessed by SPARCC enthesitis index in filgotinib treated subjects as compared to placebo [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
- Dactilytis as assessed by LDI in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the effect of filgotinib on Dactilytis in PsA patients
- Physical function as assessed by HAQ-DI in filgotinib treated subjects as compared to placebo [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
- FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo [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
- Assessment of SF-36 in filgotinib treated subjects as compared to placebo [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
- Assessment of Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) in filgotinib treated subjects as compared to placebo [At each visit from screening until the final follow up visit (week 20)]
To assess the effect of filgotinib on PsAID in PsA patients
- Difference between the number of filgotinib treated subjects and placebo subjects in the number of adverse events [From screening until the final follow up visit (week 20)]
To evaluation safety and tolerability of filgotinib in PsA patients
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal clinical laboratory evaluations [From screening until the final follow up visit (week 20)]
To evaluation safety and tolerability of filgotinib in PsA patients
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal vital signs [From screening until the final follow up visit (week 20)]
To evaluation safety and tolerability of filgotinib in PsA patients
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination [From screening until the final follow up visit (week 20)]
To evaluation safety and tolerability of filgotinib in PsA patients
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG [From screening until the final follow up visit (week 20)]
To evaluation safety and tolerability of filgotinib in PsA patients
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment [From screening until the final follow up visit (week 20)]
To evaluation safety and tolerability of filgotinib in PsA patients
Eligibility Criteria
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ULB Hopital Erasme, Service de Rheumatology | Brussels | Belgium | ||
| 2 | UMHAT "Kaspela", EOOD | Plovdiv | Bulgaria | ||
| 3 | MHAT - Ruse, AD | Ruse | Bulgaria | ||
| 4 | UMHAT "SofiaMed", OOD, Block 1 | Sofia | Bulgaria | ||
| 5 | UMHAT "Sv. Ivan Rilski", EAD | Sofia | Bulgaria | ||
| 6 | CCBR Czech, a.s | Pardubice | Czechia | ||
| 7 | MEDICAL PLUS s.r.o. | Uherské Hradiště | Czechia | ||
| 8 | Center for Clinical and Basic Research | Tallinn | Estonia | ||
| 9 | North Estonia Medical Centre Foundation | Tallinn | Estonia | ||
| 10 | OÜ Innomedica | Tallinn | Estonia | ||
| 11 | Twoja Przychodnia-Centrum Medyczne Nowa Sol | Nowa Sól | Poland | ||
| 12 | Ai Centrum Medyczne sp. z o.o. sp.k. | Poznań | Poland | ||
| 13 | Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna | Toruń | Poland | ||
| 14 | Centrum Medyczne AMED, Warszawa Targowek | Warsaw | Poland | ||
| 15 | Hospital Universitario de Fuenlabrada, Servicio de Reumatologia | Fuenlabrada | Spain | ||
| 16 | Hospital Infanta Luisa, Servicio de Reumatologia | Sevilla | Spain | ||
| 17 | CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics | Kharkiv | Ukraine | ||
| 18 | CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy | Kiev | Ukraine | ||
| 19 | SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh | Kiev | Ukraine | ||
| 20 | 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 | ||
| 21 | M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy | Poltava | Ukraine | ||
| 22 | CI of TRC | Ternopil' | Ukraine | ||
| 23 | M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1 | Vinnytsya | Ukraine | ||
| 24 | MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology | Vinnytsya | Ukraine | ||
| 25 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLPG0634-CL-224