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

Lakefront Biotherapeutics NV131 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

131

Conditions

Psoriatic Arthritis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (25)

ULB Hopital Erasme, Service de Rheumatology

Brussels, Belgium

UMHAT "Kaspela", EOOD

Plovdiv, Bulgaria

MHAT - Ruse, AD

Rousse, Bulgaria

UMHAT "SofiaMed", OOD, Block 1

Sofia, Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

CCBR Czech, a.s

Pardubice, Czechia

MEDICAL PLUS s.r.o.

Uherské Hradiště, Czechia

Center for Clinical and Basic Research

Tallinn, Estonia

North Estonia Medical Centre Foundation

Tallinn, Estonia

OÜ Innomedica

Tallinn, Estonia

...and 15 more locations

Outcomes

Primary Outcomes

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

Time frame: Week 16