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

Psoriatic Arthritis Clinical Trial

— EQUATOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101670
• Other study ID #: GLPG0634-CL-224
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2017
• Last updated: April 20, 2018
• Start date: March 9, 2017
• Est. completion date: March 12, 2018

Study information

• Verified date: April 2018
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• filgotinib
one filgotinib oral tablet q.d.
• Placebo Oral Tablet
one placebo oral tablet q.d.

Locations

Country	Name	City	State
Belgium	ULB Hopital Erasme, Service de Rheumatology	Brussels
Bulgaria	UMHAT "Kaspela", EOOD	Plovdiv
Bulgaria	MHAT - Ruse, AD	Ruse
Bulgaria	UMHAT "SofiaMed", OOD, Block 1	Sofia
Bulgaria	UMHAT "Sv. Ivan Rilski", EAD	Sofia
Czechia	CCBR Czech, a.s	Pardubice
Czechia	MEDICAL PLUS s.r.o.	Uherské Hradište
Estonia	Center for Clinical and Basic Research	Tallinn
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	OÜ Innomedica	Tallinn
Poland	Twoja Przychodnia-Centrum Medyczne Nowa Sol	Nowa Sól
Poland	Ai Centrum Medyczne sp. z o.o. sp.k.	Poznan
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna	Torun
Poland	Centrum Medyczne AMED, Warszawa Targowek	Warsaw
Spain	Hospital Universitario de Fuenlabrada, Servicio de Reumatologia	Fuenlabrada
Spain	Hospital Infanta Luisa, Servicio de Reumatologia	Sevilla
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 NS? 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

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Czechia,  Estonia,  Poland,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)