An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

NCT03320876 | Terminated Phase 2

• 2 other identifiers: GLPG0634-CL-2252017-000545-52
• Study Type: interventional
• Target: 122
• Locations: 6 countries
• Sites: 23

Brief Summary

This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Change in the proportion of subjects with adverse events

  To asses safety and tolerability of filgotinib.

  Between entry visit and 4 weeks after the last dose.

Secondary Outcomes (28)

• Proportion of subjects achieving minimal disease activity (MDA)

  At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

• Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response

  At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

• Proportion of subjects achieving ACR50 response

  At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

• Proportion of subjects achieving ACR70 response

  At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

• Proportion of subjects with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS ≤ 3.2)

  At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Study Arms (1)

filgotinib

EXPERIMENTAL

Drug: filgotinib

Interventions

filgotinib DRUG

one filgotinib oral tablet once daily.

filgotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects who are ≥18 years of age, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigator's judgment.
• Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol.
• Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments.

You may not qualify if:

• Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed.
• Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigator's clinical judgment.
• Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues.
• Subjects who require immunization with live/live attenuated vaccine.
• Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögren's syndrome.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (25)

ULB Hopital Erasme, Service de Rheumatology

Brussels, Belgium

Location

UMHAT "Kaspela", EOOD

Plovdiv, Bulgaria

Location

MHAT - Ruse, AD

Rousse, Bulgaria

Location

UMHAT "SofiaMed", OOD, Block 1

Sofia, Bulgaria

Location

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

Location

CCBR Czech, a.s

Pardubice, Czechia

Location

MEDICAL PLUS s.r.o.

Uherské Hradiště, Czechia

Location

Center for Clinical and Basic Research

Tallinn, Estonia

Location

North Estonia Medical Centre Foundation

Tallinn, Estonia

Location

OÜ Innomedica

Tallinn, Estonia

Location

Twoja Przychodnia-Centrum Medyczne Nowa Sol

Nowa Sól, Poland

Location

Ai Centrum Medyczne sp. z o.o. sp.k.

Poznan, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna

Torun, Poland

Location

Centrum Medyczne AMED, Warszawa Targowek

Warsaw, Poland

Location

Hospital Universitario de Fuenlabrada, Servicio de Reumatologia

Fuenlabrada, Spain

Location

Hospital Infanta Luisa, Servicio de Reumatologia

Seville, Spain

Location

CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics

Kharkiv, Ukraine

Location

CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy

Kiev, Ukraine

Location

SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh

Kyiv, Ukraine

Location

CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology

Lviv, Ukraine

Location

M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy

Poltava, Ukraine

Location

CI of TRC

Ternopil, Ukraine

Location

M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1

Vinnytsia, Ukraine

Location

MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Vinnytsia, Ukraine

Location

SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy

Vinnytsia, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vijay Rajendran, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 25, 2017
• Study Start: July 26, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (9); BE (1); PL (4); CZ (2); ES (3); BU (4)