Clinical Trial Details

NCT ID: NCT03117270
Date Last Changed: October 3, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of filgotinib and Placebo Oral Tablet to evaluate Ankylosing Spondylitis

Research Study Title

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing Spondylitis

Purpose

This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum of 20 weeks (from Screening visit to Follow-up visit).

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Galapagos NV
Duration
14 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Key Inclusion Criteria:

  • Male or female subjects who are ≥18 years of age on the day of signing informed consent.

  • Diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the Modified New York (NY) criteria

  • Have active ankylosing spondylitis with a BASDAI ≥4 (numeric rating scale [NRS] 0-10) and spinal pain ≥4 (0-10 NRS) (based on BASDAI question 2, see protocol) at screening and baseline.

  • Have had a documented inadequate response to NSAIDs including cyclooxygenase-2 (COX-2) inhibitors.

  • If using cDMARD therapy, stable dose for at lead 4 weeks prior to Baseline.

  • If using non-drug therapies (including physical therapies), these should be kept stable 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 COX-2 inhibitor.

  • Contraindication to MRI.

  • History of known or suspected complete ankylosis of the spine.

  • Presence of very poor functional status or unable to perform self-care.

  • Have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening.

  • Administration of a live or attenuated vaccine within 12 weeks prior to baseline.

Site Locations (21)

Country State City Zip Facility and Contact
Belgium Brussels ULB Hopital Erasme, Service de Rheumatology
Bulgaria Plovdiv UMHAT Kaspela EOOD
Bulgaria Sofia UMHAT "Sv. Ivan Rilski", EAD
Czechia Ostrava Revmatologicka ambulance
Czechia Pardubice CCBR Czech, a.s
Czechia Uherské Hradiště MEDICAL PLUS s.r.o.
Estonia Tallinn North Estonia Medical Centre Foundation
Estonia Tallinn OÜ Innomedica
Poland Nowa Sól Twoja Przychodnia-Centrum Medyczne Nowa Sol
Poland Poznań Ai Centrum Medyczne sp. z o.o. sp.k.
Spain Sevilla Hospital Infanta Luisa, Servicio de Reumatologia
Ukraine Kharkiv CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
Ukraine Kiev CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
Ukraine Kiev SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
Ukraine L'viv CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
Ukraine Poltava M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
Ukraine Ternopil' CI of TRC
Ukraine Uzhgorod A.Novak Transcarpathian Regional Clinical Hospital, Dept of Rheumatology
Ukraine Vinnytsia M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
Ukraine Vinnytsia SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
Ukraine Vinnytsya MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Contact

Evelyn Fox
+31 71 7506 710
E-mail:

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