Clinical trial NCT03101670: A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2017-04-05
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Percentage of subjects who have reached ACR20 response as compared to placebo
timeFrame: Week 16
Secondary outcomes:
measure: Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Percentage of subjects who have reached ACR50 response as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Percentage of subjects who have reached ACR70 response as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Percentage of subjects achieving DAS28(CRP) score as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Percentage of subjects achieving SDAI response as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Percentage of subjects achieving CDAI response as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Percentage of subjects achieving EULAR response as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Assessment of physician's and patient's global assessment of disease activity as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Assessment of patient's global assessment of PsA pain intensity in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Assessment of joints for tenderness (68) and swelling (66) in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Assessment of CRP in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Assessment of mNAPSI in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Enthesitis as assessed by SPARCC enthesitis index in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Dactilytis as assessed by LDI in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Physical function as assessed by HAQ-DI in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Assessment of SF-36 in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Assessment of Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) in filgotinib treated subjects as compared to placebo
timeFrame: At each visit from screening until the final follow up visit (week 20)
measure: Difference between the number of filgotinib treated subjects and placebo subjects in the number of adverse events
timeFrame: From screening until the final follow up visit (week 20)
measure: Difference between the number of filgotinib treated subjects and placebo subjects with abnormal clinical laboratory evaluations
timeFrame: From screening until the final follow up visit (week 20)
measure: Difference between the number of filgotinib treated subjects and placebo subjects with abnormal vital signs
timeFrame: From screening until the final follow up visit (week 20)
measure: Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination
timeFrame: From screening until the final follow up visit (week 20)
measure: Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG
timeFrame: From screening until the final follow up visit (week 20)
measure: Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment
timeFrame: From screening until the final follow up visit (week 20)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: ULB Hopital Erasme, Service de Rheumatology
city: Plovdiv
country: Bulgaria
facility: UMHAT "Kaspela", EOOD
city: Ruse
country: Bulgaria
facility: MHAT - Ruse, AD
city: Sofia
country: Bulgaria
facility: UMHAT "SofiaMed", OOD, Block 1
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Pardubice
country: Czechia
facility: CCBR Czech, a.s
city: Uherské Hradiště
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tallinn
country: Estonia
facility: OÜ Innomedica
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia-Centrum Medyczne Nowa Sol
city: Poznań
country: Poland
facility: Ai Centrum Medyczne sp. z o.o. sp.k.
city: Toruń
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
city: Warsaw
country: Poland
facility: Centrum Medyczne AMED, Warszawa Targowek
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa, Servicio de Reumatologia
city: Kharkiv
country: Ukraine
facility: CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
city: Kiev
country: Ukraine
facility: CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
city: Kiev
country: Ukraine
facility: SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
city: L'viv
country: Ukraine
facility: CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
city: Poltava
country: Ukraine
facility: M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
city: Ternopil'
country: Ukraine
facility: CI of TRC
city: Vinnytsya
country: Ukraine
facility: M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
city: Vinnytsya
country: Ukraine
facility: MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
city: Vinnytsya
country: Ukraine
facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
Study officials:
affiliation: Galapagos NV
name: Pille Harrison, MD, DPhil, MRCP (UK)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.