A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis

NCT ID: NCT05785611

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 495 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2028-12-31

Brief Summary

This study is comparing 200 milligrams (mg) of filgotinib a day with a placebo to see if filgotinib helps to treat Axial Spondyloarthritis (axSpA) and is safe to use. The study will also be comparing 200 mg with 100 mg filgotinib a day to see if the lower dose also helps to treat axSpA.

Conditions

Axial Spondyloarthritis

Study Design

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

Study Groups

Radiographic Part (Study A) Filgotinib

Participants will receive filgotinib 200 mg or placebo to match filgotinib. Participants will receive blinded treatment until Week 16. After that participants with an age under 65 and without certain health risks will enter open label period and will receive filgotinib 200 mg until Week 52. Participants reaching an Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 at weeks 40 and 52, will enter dose de-escalation phase and will be randomized to filgotinib 200 or 100 mg until Week 104. Participants, with an age of 65 or above or with certain health risks, will enter open label period until Week 104 and will receive 100 or 200 mg filgotinib a day, depending on their axSpA symptoms. The maximum duration of treatment period will be up to Week 104.

Where applicable, participants will be able to enter an open-label extension period until week 234.

Group Type: EXPERIMENTAL

Filgotinib

Intervention Type: DRUG

Tablets administered orally once daily

Placebo

Intervention Type: DRUG

Tablets administered orally once daily

Non-radiographic Part (Study B) Filgotinib

Participants will receive filgotinib 200 mg or placebo to match filgotinib. Participants will receive blinded treatment until Week 16. After that participants with an age under 65 and without certain health risks will enter open label period and will receive filgotinib 200 mg until Week 52. Participants reaching an ASDAS <2.1 at weeks 40 and 52, will enter dose de-escalation phase and will be randomized to filgotinib 200 or 100 mg until Week 104. Participants, with an age of 65 or above or with certain health risks, will enter open label period until Week 104 and will receive 100 or 200 mg filgotinib a day, depending on their axSpA symptoms. The maximum duration of treatment period will be up to Week 104.

Where applicable, participants will be able to enter an open-label extension period until week 234.

Group Type: EXPERIMENTAL

Filgotinib

Intervention Type: DRUG

Tablets administered orally once daily

Placebo

Intervention Type: DRUG

Tablets administered orally once daily

Interventions

Filgotinib

Tablets administered orally once daily

Intervention Type: DRUG

Placebo

Tablets administered orally once daily

Intervention Type: DRUG

Other Intervention Names

GS-6034; GLPG0634

Eligibility Criteria

Inclusion Criteria

• Have an established diagnosis of axSpA by a rheumatologist (or other specialist with expertise in diagnosing axSpA).
• Study A (r-axSpA): Meet Assessment of SpondyloArthritis International Society (ASAS) classification criteria with radiographic sacroiliitis on X-ray as follows:

1. History of back pain >=12 weeks and age at onset of back pain <45 years, AND

2. Have radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, based on New York grading system, confirmed by central reading, AND,

3. >=1 spondyloarthritis (SpA) feature.

• Study B (nr- axSpA): Meet ASAS classification criteria without radiographic sacroiliitis on X-ray as follows:

1. History of back pain >= 12 weeks and age at onset of back pain <45 years, AND

2. No radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, AND,

3. Presence of sacroiliitis on MRI (based on central reading) and at least 1 SpA feature or when positive for human leukocyte antigen (HLA)-B27: having at least 2 SpA features, AND

4. Have objective signs of inflammation, by sacroiliitis on MRI or elevated CRP.

• Have active axSpA at screening and Day 1 defined by:

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 (numeric rating scale [NRS] 0-10), AND
• Spinal pain score >=4 (0-10 NRS) (based on BASDAI question 2),
• Have a history of inadequate response to >=2 NSAIDs at the maximum dose of NSAIDs used in axSpA for >=2 weeks each (a total duration of NSAID trial >=4 weeks) or intolerance to >=2 NSAIDs for the treatment of axSpA.
• Participants who are biologic disease-modifying antirheumatic drug (BDMARD)(s) experienced; defined as below.

• Participants designated as bDMARD(s)-inadequate responder(IR) must have received not more than 2 bDMARD(s), that was/were administered in accordance with its/their labeling and discontinued due to:

• Non-response (primary or secondary) after a minimum treatment of 12 weeks, and /or
• Intolerance (defined as having experienced an adverse reaction [e.g. an infusion/injection reaction, an infection, a laboratory test change, etc] irrespective of treatment duration)
• Participants designated as bDMARD(s) non-IR have previously received bDMARD(s) and have discontinued these due to other reasons than non-response or intolerance (e.g. economic reasons, treatment as part of a clinical study, other, or unknown).
• If continuing conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) during the study, participants are permitted to use only a maximum of 2 csDMARDs and must have been on this treatment for >=12 weeks prior to screening, with a stable dose and route of administration (defined as no change in prescription) for >4 weeks prior to Day 1.
• For participants aged 65 years or above on the date of signing the informed consent form (ICF), the investigator should carefully consider if participation is in the best interest of the participant.

Exclusion Criteria

• Prior exposure to a Janus kinase inhibitor, investigational or approved, at any time, including filgotinib.
• Use of any opioid analgesic at average daily doses >30 mg/day of morphine (or equivalent) or use of unstable doses of any opioid analgesic <=2 weeks prior to Day 1.
• Use of any of the following systemic immunomodulating therapies <= 4 weeks prior to Day 1, including, but not limited to: 6-mercaptopurine, azathioprine, cyclosporine or other calcineurin inhibitors (e.g. sirolimus, tacrolimus), methotrexate if being discontinued, mycophenolate, antimalarials (e.g. hydroxychloroquine, chloroquine) if being discontinued, or sulfasalazine if being discontinued.
• Complete spinal ankylosis defined as the presence of consecutive bridging syndesmophytes in >=5 segments on the lateral radiograph (assessed by the central reader).
• Have undergone surgical treatments for peripheral manifestation of axSpA, including synovectomy or arthroplasty, or major surgery (requiring regional block or general anesthesia) <=12 weeks prior to Day 1 or planned major surgery during the study.
• Have a diagnosis of any generalized musculoskeletal disorder, e.g. generalized osteoarthritis, or systemic inflammatory condition other than axSpA.
• Have active Crohn's disease (CD) or active ulcerative colitis (UC). Note: participants may be enrolled if they have had a history of inflammatory bowel disease (IBD), including CD and UC, but have had no exacerbation within 6 months prior to Day 1, and, if currently on treatment, must be on stable treatment for >=6 months prior to Day 1 and this treatment should be allowed per protocol.
• Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the participant by participating in the study (e.g. uncontrolled uveitis, uncontrolled thyroiditis, transverse myelitis, current peptic ulcer disease or prior history of severe diverticulitis [i.e. requiring hospitalization] or previous gastrointestinal perforation), per judgment of investigator,
• History of opportunistic infection, or immunodeficiency syndrome, which would put the participant at risk, as per investigator judgment,
• Active infection that is clinically significant, as per judgment of the investigator, or history of a serious infection (requiring hospitalization or systemic antibiotics) within 12 weeks prior to screening.
• Participant has a history of malignancy or myelo- or lymphoproliferative disorder, including non-melanoma skin cancer (NMSC), excised and curatively treated non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or in situ uterine cervical carcinoma within the past 5 years prior to screening.
• Participant has any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. For participants at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past (>10 pack-years) and those at increased risk of cancer, the investigator should carefully consider if participation is in the best interest of the participant.
• Contraindication to magnetic resonance imaging (MRI).

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

Sponsors

Alfasigma S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfasigma Study Director

Role: STUDY_DIRECTOR

Alfasigma S.p.A.

Locations

Hopital Charles Nicolle

Rouen, , France

Charite Medizinische Klinik I

Berlin, , Germany

Hamburger Rheuma II

Hamburg, , Germany

Rheumazentrum Ruhrgebiet

Herne, , Germany

Klinische Forschung im med

Planegg, , Germany

Universitatsklinikum Wurzburg

Würzburg, , Germany

Revita Rheumatologiai Kft

Budapest, , Hungary

University of Debrecen

Debrecen, , Hungary

Reumatologiai es Immunologiai

Pécs, , Hungary

Vita Verum Medical

Székesfehérvár, , Hungary

Obudai Egeszsegugyi Centrum

Zalaegerszeg, , Hungary

Istituto Ortopedico Rizzoli

Bologna, , Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Napoli, , Italy

Policlinico Paolo Giaccone

Palermo, , Italy

Policlinico Uni Campus Bio-Med

Rome, , Italy

Policlinico Universitario Agostino Gemelli

Rome, , Italy

Ospedale SM Misericordia

Udine, , Italy

Kaunas Hospital of LUHSCP

Kaunas, , Lithuania

Kaunas City Polyclinic

Kaunas, , Lithuania

Klaipeda University Hospital, Public Institution

Klaipėda, , Lithuania

Vilnius UH Santariskiu Clinics

Vilnius, , Lithuania

Medisch Spectrum Twente

Enschede, , Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Ilocos Training and Regional Medical Center

San Fernando City, La Union, Philippines

Ospital Ng Makati

Makati City, National Capital Region, Philippines

Lipa Medix Medical Center

Lipa City, , Philippines

Mary Mediatrix Medical Center

Lipa City, , Philippines

Medical Center Manila

Manila, , Philippines

The Medical City Clark, Mabalacat

Pampanga, , Philippines

St. Luke's Medical Center

Quezon City, , Philippines

Far Eastern University - Dr. Nicanor Reyes Medical Foundation

Quezon City, , Philippines

ZDROWIE Osteo Medic

Bialystok, , Poland

Centrum Kliniczno Badawcze

Elblag, , Poland

Silmedic sp. z o. o

Katowice, , Poland

Reumed Spolka z o o

Lubin, , Poland

KO-MED Centra Kliniczne

Lublin, , Poland

Twoja Przychodnia NCM

Nowa Sól, , Poland

ETYKA Osrodek Badan Klinicznyc

Olsztyn, , Poland

TPO Centrum Medyczne

Opole, , Poland

Solumed Medical Center

Poznan, , Poland

AI Centrum Medyczne

Poznan, , Poland

Twoja Przychodnia PCM

Poznan, , Poland

KO-MED Centra Kliniczne

Staszów, , Poland

MICS Medical Center Torun

Torun, , Poland

MICS Centrum Medyczne

Warsaw, , Poland

Cliniques Universitaires de Bruxelles Hopital Erasme

Brussels, , Belgium

ReumaClinic

Genk, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

CHU Helora

Mons, , Belgium

Medical Center Rodopimed

Kardzhali, , Bulgaria

MC Medconsult Pleven

Pleven, , Bulgaria

UMHAT Plovdiv AD

Plovdiv, , Bulgaria

UMHAT Eurohospital Plovdiv

Plovdiv, , Bulgaria

Medical Center UNIMED EOOD

Plovdiv, , Bulgaria

Medical Center Teodora

Rousse, , Bulgaria

Medical Center 1 Sevlievo

Sevlievo, , Bulgaria

DCC Ascendent EOOD

Sofia, , Bulgaria

UMHAT Sofiamed OOD

Sofia, , Bulgaria

Dcc Focus 5 Meoh Ood

Sofia, , Bulgaria

Dcc Focus 5 Meoh

Sofia, , Bulgaria

DCC XVII-Sofia EOOD

Sofia, , Bulgaria

Medical Center Hera

Sofia, , Bulgaria

Medical Center N I PIROGOV

Sofia, , Bulgaria

Military Medical Academy MHAT

Sofia, , Bulgaria

UMHAT Stoyan Kirkovich AD

Stara Zagora, , Bulgaria

Lekarna U Revmatologickeho

Prague, Nove Mesto, Czechia

Fakultni nemocnice u sv Anny, Interni klinika

Brno, , Czechia

Revmaclinic s r o

Brno, , Czechia

Lekarna BENU

Brno, , Czechia

Revmatologie s r o

Brno, , Czechia

CCR Ostrava

Ostrava, , Czechia

Vesalion Revma ambulance

Ostrava, , Czechia

Artroscan s r o

Ostrava, , Czechia

ARTHROHELP s r o

Pardubice, , Czechia

CCR Czech a s

Pardubice, , Czechia

MUDR. Zuzana URBANOVA Revmatologie

Prague, , Czechia

Fakultni nemocnice Motol

Prague, , Czechia

Medical Plus Sro

Uherské Hradiště, , Czechia

PV Medical Services

Zlín, , Czechia

Clinical Research Centre

Tartu, , Estonia

Meditrials OU

Tartu, , Estonia

APHP Hopital Ambroise Pare

Boulogne-Billancourt, , France

Hopital Edouard Herriot

Lyon, , France

CHR d'Orleans

Orléans, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Instytut Reumatologii im. Eleonory Reicher

Warsaw, , Poland

ETG Warszawa

Warsaw, , Poland

Klinika Reuma Park

Warsaw, , Poland

FutureMeds Wroclaw

Wroclaw, , Poland

Sj de Urgenta Bacau

Bacau, , Romania

S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

Brasov, , Romania

SC Delta Health Care SRL

Bucharest, , Romania

Spitalul Clinic Judetean de Urgenta

Cluj-Napoca, , Romania

Aqua Med Consulting SRL

Constanța, , Romania

SC Medisof Diagnostic SRL

Craiova, , Romania

Centrul Medical Unirea SRL

Iași, , Romania

Sc Medaudio Optica Srl

Râmnicu Vâlcea, , Romania

S.C Centrul Medical Unirea SR

Târgu Mureş, , Romania

Clinresco Centres Pty Ltd,

Kempton Park, , South Africa

Arthritis Clinical Trial Centre

Pinelands, , South Africa

Emmed Research

Pretoria, , South Africa

Winelands Medical Research Centre

Stellenbosch, , South Africa

Chonnam National University Hospital

Gwangju, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Hanyang University Seoul Hospital

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Hospital Marina Baixa

Alicante, , Spain

UH Parc Tauli

Barcelona, , Spain

Hospital Universitario Basurto

Bilbao, , Spain

HU Reina Sofia

Córdoba, , Spain

Hospital Universitario La Paz

Madrid, , Spain

HU Marques de Valdecilla

Santander, , Spain

Clinica GAIAS Santiago

Santiago de Compostela, , Spain

HU Virgen Macarena

Seville, , Spain

UH Virgen de Valme

Seville, , Spain

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Royal United Hospital Bath NHS Foundation Trust

Bath, , United Kingdom

Norfolk & Norwich University Hospital

Norwich, , United Kingdom

Countries

Belgium; Bulgaria; Czechia; Estonia; France; Germany; Hungary; Italy; Lithuania; Netherlands; Philippines; Poland; Romania; South Africa; South Korea; Spain; Taiwan; United Kingdom

Other Identifiers

2022-501354-10-01

Identifier Type: CTIS

Identifier Source: secondary_id

GLPG0634-CL-336

Identifier Type: -

Identifier Source: org_study_id