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

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

filgotinib

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ULB Hopital Erasme, Service de Rheumatology
UMHAT "Kaspela", EOOD
MHAT - Ruse, AD
UMHAT "SofiaMed", OOD, Block 1
UMHAT "Sv. Ivan Rilski", EAD
CCBR Czech, a.s
MEDICAL PLUS s.r.o.
Center for Clinical and Basic Research
North Estonia Medical Centre Foundation
OÜ Innomedica
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Ai Centrum Medyczne sp. z o.o. sp.k.
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
Centrum Medyczne AMED, Warszawa Targowek
Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
Hospital Infanta Luisa, Servicio de Reumatologia
CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
CI of TRC
M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

filgotinib

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

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

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

Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo

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

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

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

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

To assess the effect of filogotinib on CRP in PsA patients

Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo

To assess the effect of filgotinib on PASI in PsA patients

Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo

To assess the effect of filgotinib on PASI50 in PsA patients

Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo

To assess the affect of filgotinib on PASI75 in PsA patients

Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo

To assess the affect of filgotinib on PASI90 in PsA patients

Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo

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

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

To assess the effect of filgotinib on mNAPSI in PsA patients

Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo

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

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

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

To assess the effect of filgotinib on physical function in PsA patients

FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo

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

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

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

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

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

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

To evaluation safety and tolerability of filgotinib in PsA patients

Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG

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

To evaluation safety and tolerability of filgotinib in PsA patients

Full Information

NCT ID

NCT03101670

First Posted

March 30, 2017

Last Updated

April 20, 2018

Sponsor

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT03101670

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

March 9, 2017 (Actual)

Primary Completion Date

March 12, 2018 (Actual)

Study Completion Date

March 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

filgotinib

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

filgotinib

Intervention Description

one filgotinib oral tablet q.d.

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

one placebo oral tablet q.d.

Primary Outcome Measure Information:

Title

Percentage of subjects who have reached ACR20 response as compared to placebo

Description

To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo

Description

To assess the effect of filogotinib on MDA in PsA patients

Time Frame