A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis

NCT ID: NCT03117270

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-07
• Study Completion Date: 2018-07-02

Brief Summary

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).

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

oral filgotinib tablets

Group Type: EXPERIMENTAL

filgotinib

Intervention Type: DRUG

one filgotinib oral tablet q.d.

placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

one placebo oral tablet q.d.

Interventions

filgotinib

one filgotinib oral tablet q.d.

Intervention Type: DRUG

Placebo Oral Tablet

one placebo oral tablet q.d.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pille Harrison, MD, DPhil, MRCP (UK)

Role: STUDY_DIRECTOR

Galapagos NV

Locations

ULB Hopital Erasme, Service de Rheumatology

Brussels, , Belgium

Eurohospital

Plovdiv, , Bulgaria

UMHAT Kaspela EOOD

Plovdiv, , Bulgaria

Medical Center "Teodora", EOOD

Rousse, , Bulgaria

Akademik Ivan Geshov, UMHAT "Sv. Ivan Rilski", EAD

Sofia, , Bulgaria

Clinic of Rheumatology, UMHAT "Sv. Ivan Rilski", EAD

Sofia, , Bulgaria

UMHAT "SofiaMed", OOD, Block 1

Sofia, , Bulgaria

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

Stara Zagora, , Bulgaria

Revmatologicka ambulance

Ostrava, , Czechia

CCBR Czech, a.s

Pardubice, , Czechia

MEDICAL PLUS s.r.o.

Uherské Hradiště, , Czechia

OÜ Innomedica

Tallinn, , Estonia

Centrum Medyczne SILESIANA Sp z oo

Bytom, , 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, , Poland

Corporacio Sanitaria Parc Tauli, Servicio de Reumatologia

Santiago de Compostela, , Spain

Hospital Infanta Luisa, Servicio de Reumatologia

Seville, , Spain

Hospital Universitario Virgen Macarena, Dept. of Rheumatology

Seville, , Spain

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 NSС 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

Lviv, , Ukraine

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

Poltava, , Ukraine

CI of TRC

Ternopil, , Ukraine

A.Novak Transcarpathian Regional Clinical Hospital, Dept of Rheumatology

Uzhhorod, , Ukraine

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

Vinnytsia, , Ukraine

MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Vinnytsia, , Ukraine

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

Vinnytsia, , Ukraine

Countries

Belgium; Bulgaria; Czechia; Estonia; Poland; Spain; Ukraine

References

Maksymowych WP, Ostergaard M, Landewe R, Barchuk W, Liu K, Gilles L, Hendrikx T, Besuyen R, Baraliakos X. Filgotinib decreases both vertebral body and posterolateral spine inflammation in ankylosing spondylitis: results from the TORTUGA trial. Rheumatology (Oxford). 2022 May 30;61(6):2388-2397. doi: 10.1093/rheumatology/keab758.

Reference Type: DERIVED

PMID: 34647992 (View on PubMed)

Maksymowych WP, Ostergaard M, Landewe R, Barchuk W, Liu K, Tasset C, Gilles L, Hendrikx T, Besuyen R, Baraliakos X. Impact of filgotinib on sacroiliac joint magnetic resonance imaging structural lesions at 12 weeks in patients with active ankylosing spondylitis (TORTUGA trial). Rheumatology (Oxford). 2022 May 5;61(5):2063-2071. doi: 10.1093/rheumatology/keab543.

Reference Type: DERIVED

PMID: 34352069 (View on PubMed)

van der Heijde D, Baraliakos X, Gensler LS, Maksymowych WP, Tseluyko V, Nadashkevich O, Abi-Saab W, Tasset C, Meuleners L, Besuyen R, Hendrikx T, Mozaffarian N, Liu K, Greer JM, Deodhar A, Landewe R. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Dec 1;392(10162):2378-2387. doi: 10.1016/S0140-6736(18)32463-2. Epub 2018 Oct 22.

Reference Type: DERIVED

PMID: 30360970 (View on PubMed)

Other Identifiers

GLPG0634-CL-223

Identifier Type: -

Identifier Source: org_study_id