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

NCT05785611 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: GLPG0634-CL-3362022-501354-10-01
• Study Type: interventional
• Target: 495
• Locations: 17 countries
• Sites: 121

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

Keywords

chronic inflammatory disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving SpondyloArthritis International Society 40% improvement (ASAS40) Response (Yes/No) at Week 16

  Week 16

Secondary Outcomes (6)

• Change from baseline in Ankylosing Spondylitis DiseaseActivity Score with C-reactive protein (ASDASCRP) at Week 16

  Week 16

• Change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score of Sacroiliac Joints (SIJs) at Week 16

  Week 16

• Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16

  Week 16

• Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16

  Week 16

• Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) (linear score) at Week 16

  Week 16

Study Arms (2)

Radiographic Part (Study A) Filgotinib

EXPERIMENTAL

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.

Drug: Filgotinib; Drug: Placebo

Non-radiographic Part (Study B) Filgotinib

EXPERIMENTAL

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.

Drug: Filgotinib; Drug: Placebo

Interventions

Filgotinib DRUG

Tablets administered orally once daily

Also known as: GS-6034, GLPG0634

Non-radiographic Part (Study B) Filgotinib; Radiographic Part (Study A) Filgotinib

Placebo DRUG

Tablets administered orally once daily

Non-radiographic Part (Study B) Filgotinib; Radiographic Part (Study A) Filgotinib

Eligibility Criteria

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

You may qualify if:

• 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:
• History of back pain \>=12 weeks and age at onset of back pain \<45 years, AND
• Have radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, based on New York grading system, confirmed by central reading, AND,
• \>=1 spondyloarthritis (SpA) feature.
• Study B (nr- axSpA): Meet ASAS classification criteria without radiographic sacroiliitis on X-ray as follows:
• History of back pain \>= 12 weeks and age at onset of back pain \<45 years, AND
• No radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, AND,
• 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
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alfasigma S.p.A.: lead

Study Sites (123)

Cliniques Universitaires de Bruxelles Hopital Erasme

Brussels, 1070, Belgium

Location

ReumaClinic

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU Helora

Mons, 7000, Belgium

Location

Medical Center Rodopimed

Kardzhali, 6600, Bulgaria

Location

MC Medconsult Pleven

Pleven, 5800, Bulgaria

Location

UMHAT Plovdiv AD

Plovdiv, 4003, Bulgaria

Location

UMHAT Eurohospital Plovdiv

Plovdiv, 4004, Bulgaria

Location

Medical Center UNIMED EOOD

Plovdiv, 4023, Bulgaria

Location

Medical Center Teodora

Rousse, 7000, Bulgaria

Location

Medical Center 1 Sevlievo

Sevlievo, 5400, Bulgaria

Location

DCC Ascendent EOOD

Sofia, 1202, Bulgaria

Location

UMHAT Sofiamed OOD

Sofia, 1336, Bulgaria

Location

Dcc Focus 5 Meoh Ood

Sofia, 1463, Bulgaria

Location

Dcc Focus 5 Meoh

Sofia, 1463, Bulgaria

Location

DCC XVII-Sofia EOOD

Sofia, 1505, Bulgaria

Location

Medical Center Hera

Sofia, 1510, Bulgaria

Location

Medical Center N I PIROGOV

Sofia, 1606, Bulgaria

Location

Military Medical Academy MHAT

Sofia, 1606, Bulgaria

Location

UMHAT Stoyan Kirkovich AD

Stara Zagora, 6003, Bulgaria

Location

Lekarna U Revmatologickeho

Prague, Nove Mesto, 12800, Czechia

Location

Fakultni nemocnice u sv Anny, Interni klinika

Brno, 60 200, Czechia

Location

Revmaclinic s r o

Brno, 60 200, Czechia

Location

Lekarna BENU

Brno, 602 00, Czechia

Location

Revmatologie s r o

Brno, 638 00, Czechia

Location

CCR Ostrava

Ostrava, 70 200, Czechia

Location

Vesalion Revma ambulance

Ostrava, 70 200, Czechia

Location

Artroscan s r o

Ostrava, 722 00, Czechia

Location

ARTHROHELP s r o

Pardubice, 530 02, Czechia

Location

CCR Czech a s

Pardubice, 530 02, Czechia

Location

MUDR. Zuzana URBANOVA Revmatologie

Prague, 12800, Czechia

Location

Fakultni nemocnice Motol

Prague, 150 06, Czechia

Location

Medical Plus Sro

Uherské Hradiště, 68601, Czechia

Location

PV Medical Services

Zlín, 76001, Czechia

Location

Clinical Research Centre

Tartu, 50106, Estonia

Location

Meditrials OU

Tartu, 50708, Estonia

Location

APHP Hopital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

Hopital Edouard Herriot

Lyon, 69003, France

Location

CHR d'Orleans

Orléans, 45100, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Charles Nicolle

Rouen, 76000, France

Location

Charite Medizinische Klinik I

Berlin, 12203, Germany

Location

Hamburger Rheuma II

Hamburg, 20095, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

Klinische Forschung im med

Planegg, 82152, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Revita Rheumatologiai Kft

Budapest, 1027, Hungary

Location

University of Debrecen

Debrecen, 4032, Hungary

Location

Reumatologiai es Immunologiai

Pécs, 7632, Hungary

Location

Vita Verum Medical

Székesfehérvár, 8000, Hungary

Location

Obudai Egeszsegugyi Centrum

Zalaegerszeg, 8900, Hungary

Location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Naples, 80138, Italy

Location

Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Policlinico Uni Campus Bio-Med

Rome, 00128, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

Ospedale SM Misericordia

Udine, 33100, Italy

Location

Kaunas Hospital of LUHSCP

Kaunas, 45130, Lithuania

Location

Kaunas City Polyclinic

Kaunas, 51270, Lithuania

Location

Klaipeda University Hospital, Public Institution

Klaipėda, 92288, Lithuania

Location

Vilnius UH Santariskiu Clinics

Vilnius, 08661, Lithuania

Location

Medisch Spectrum Twente

Enschede, 7512 AV, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Ilocos Training and Regional Medical Center

San Fernando City, La Union, 2500, Philippines

Location

Ospital Ng Makati

Makati City, National Capital Region, 1218, Philippines

Location

Lipa Medix Medical Center

Lipa City, 4217, Philippines

Location

Mary Mediatrix Medical Center

Lipa City, 4217, Philippines

Location

Medical Center Manila

Manila, 1122, Philippines

Location

The Medical City Clark, Mabalacat

Pampanga, 2023, Philippines

Location

St. Luke's Medical Center

Quezon City, 1102, Philippines

Location

Far Eastern University - Dr. Nicanor Reyes Medical Foundation

Quezon City, 1118, Philippines

Location

ZDROWIE Osteo Medic

Bialystok, 15 351, Poland

Location

Centrum Kliniczno Badawcze

Elblag, 82 300, Poland

Location

Silmedic sp. z o. o

Katowice, 40282, Poland

Location

Reumed Spolka z o o

Lubin, 20607, Poland

Location

KO-MED Centra Kliniczne

Lublin, 21-362, Poland

Location

Twoja Przychodnia NCM

Nowa Sól, 67 100, Poland

Location

ETYKA Osrodek Badan Klinicznyc

Olsztyn, 10 117, Poland

Location

TPO Centrum Medyczne

Opole, 45 819, Poland

Location

Solumed Medical Center

Poznan, 60529, Poland

Location

AI Centrum Medyczne

Poznan, 61 113, Poland

Location

Twoja Przychodnia PCM

Poznan, 61 293, Poland

Location

KO-MED Centra Kliniczne

Staszów, 28 200, Poland

Location

MICS Medical Center Torun

Torun, 87 100, Poland

Location

MICS Centrum Medyczne

Warsaw, 00 874, Poland

Location

Instytut Reumatologii im. Eleonory Reicher

Warsaw, 02 637, Poland

Location

ETG Warszawa

Warsaw, 02 793, Poland

Location

Klinika Reuma Park

Warsaw, 02665, Poland

Location

FutureMeds Wroclaw

Wroclaw, 50 088, Poland

Location

Sj de Urgenta Bacau

Bacau, 600114, Romania

Location

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

Brasov, 500283, Romania

Location

SC Delta Health Care SRL

Bucharest, 14142, Romania

Location

Spitalul Clinic Judetean de Urgenta

Cluj-Napoca, 400006, Romania

Location

Aqua Med Consulting SRL

Constanța, 900612, Romania

Location

SC Medisof Diagnostic SRL

Craiova, 200347, Romania

Location

Centrul Medical Unirea SRL

Iași, 700023, Romania

Location

Sc Medaudio Optica Srl

Râmnicu Vâlcea, 240762, Romania

Location

S.C Centrul Medical Unirea SR

Târgu Mureş, 540136, Romania

Location

Clinresco Centres Pty Ltd,

Kempton Park, 1619, South Africa

Location

Arthritis Clinical Trial Centre

Pinelands, 7405, South Africa

Location

Emmed Research

Pretoria, 0002, South Africa

Location

Winelands Medical Research Centre

Stellenbosch, 7600, South Africa

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06273, South Korea

Location

Hospital Marina Baixa

Alicante, 03570, Spain

Location

UH Parc Tauli

Barcelona, 08208, Spain

Location

Hospital Universitario Basurto

Bilbao, 48013, Spain

Location

HU Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario La Paz

Madrid, 28 046, Spain

Location

HU Marques de Valdecilla

Santander, 39008, Spain

Location

Clinica GAIAS Santiago

Santiago de Compostela, 15702, Spain

Location

HU Virgen Macarena

Seville, 41009, Spain

Location

UH Virgen de Valme

Seville, 41014, Spain

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Royal United Hospital Bath NHS Foundation Trust

Bath, BA1 3NG, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Alfasigma Study Director

  Alfasigma S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: April 5, 2023
• Primary Completion: September 4, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (18); ES (9); KR (6); BU (16); RO (9); ZA (4); FR (5); BE (5); DE (5); PH (8); CZ (14); LI (4); HU (5); GB (2); IT (6); NL (2); TW (3)