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

A Phase 3 Randomized, Placebo-controlled, Double-blind, Parallel-group Program to Evaluate Efficacy and Safety of Filgotinib in Adult Subjects With Active Axial Spondyloarthritis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Drug: Filgotinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 495
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Cliniques Universitaires de Bruxelles Hopital Erasme
  • Genk, Belgium, 3600
    • ReumaClinic
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Mons, Belgium, 7000
    • CHU Helora
• Bulgaria
  • Kardzhali, Bulgaria, 6600
    • Medical Center Rodopimed
  • Pleven, Bulgaria, 5800
    • MC Medconsult Pleven
  • Plovdiv, Bulgaria, 4023
    • Medical Center Unimed Eood
  • Plovdiv, Bulgaria, 4003
    • UMHAT Plovdiv AD
  • Plovdiv, Bulgaria, 4004
    • UMHAT Eurohospital Plovdiv
  • Rousse, Bulgaria, 7000
    • Medical Center Teodora
  • Sevlievo, Bulgaria, 5400
    • Medical Center 1 Sevlievo
  • Sofia, Bulgaria, 1510
    • Medical Center Hera
  • Sofia, Bulgaria, 1202
    • DCC Ascendent EOOD
  • Sofia, Bulgaria, 1336
    • UMHAT Sofiamed OOD
  • Sofia, Bulgaria, 1463
    • Dcc Focus 5 Meoh Ood
  • Sofia, Bulgaria, 1463
    • Dcc Focus 5 Meoh
  • Sofia, Bulgaria, 1505
    • DCC XVII-Sofia EOOD
  • Sofia, Bulgaria, 1606
    • Medical Center N I PIROGOV
  • Sofia, Bulgaria, 1606
    • Military Medical Academy MHAT
  • Stara Zagora, Bulgaria, 6003
    • UMHAT Stoyan Kirkovich AD
• Czechia
  • Brno, Czechia, 60 200
    • Fakultni nemocnice u sv Anny, Interni klinika
  • Brno, Czechia, 60 200
    • Revmaclinic s r o
  • Brno, Czechia, 602 00
    • Lekarna BENU
  • Brno, Czechia, 638 00
    • Revmatologie s r o
  • Ostrava, Czechia, 722 00
    • Artroscan s r o
  • Ostrava, Czechia, 70 200
    • CCR Ostrava
  • Ostrava, Czechia, 70 200
    • Vesalion Revma ambulance
  • Pardubice, Czechia, 530 02
    • ARTHROHELP s r o
  • Pardubice, Czechia, 530 02
    • CCR Czech a s
  • Prague, Czechia, 12800
    • MUDR. Zuzana URBANOVA Revmatologie
  • Prague, Czechia, 150 06
    • Fakultni nemocnice Motol
  • Uherské Hradiště, Czechia, 68601
    • Medical Plus Sro
  • Zlín, Czechia, 76001
    • Pv Medical Services
  • Nove Mesto
    • Prague, Nove Mesto, Czechia, 12800
      • Lekarna U Revmatologickeho
• Estonia
  • Tartu, Estonia, 50708
    • MediTrials OÜ
  • Tartu, Estonia, 50106
    • Clinical Research Centre
• France
  • Boulogne-Billancourt, France, 92100
    • APHP Hopital Ambroise Pare
  • Lyon, France, 69003
    • Hôpital Edouard Herriot
  • Orléans, France, 45100
    • CHR d'Orléans
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Rouen, France, 76000
    • Hôpital Charles Nicolle
• Germany
  • Berlin, Germany, 12203
    • Charite Medizinische Klinik I
  • Hamburg, Germany, 20095
    • Hamburger Rheuma II
  • Herne, Germany, 44649
    • Rheumazentrum Ruhrgebiet
  • Planegg, Germany, 82152
    • Klinische Forschung im med
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
• Hungary
  • Budapest, Hungary, 1027
    • Revita Rheumatologiai Kft
  • Debrecen, Hungary, 4032
    • University of Debrecen
  • Pécs, Hungary, 7632
    • Reumatologiai es Immunologiai
  • Székesfehérvár, Hungary, 8000
    • Vita Verum Medical
  • Zalaegerszeg, Hungary, 8900
    • Óbudai Egészségügyi Centrum
• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli
  • Napoli, Italy, 80138
    • Azienda Ospedaliera Universitaria Luigi Vanvitelli
  • Palermo, Italy, 90127
    • Policlinico Paolo Giaccone
  • Rome, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Rome, Italy, 00128
    • Policlinico Uni Campus Bio-Med
  • Udine, Italy, 33100
    • Ospedale SM Misericordia
• Lithuania
  • Kaunas, Lithuania, 45130
    • Kaunas Hospital of LUHSCP
  • Kaunas, Lithuania, 51270
    • Kaunas City Polyclinic
  • Klaipėda, Lithuania, 92288
    • Klaipeda University Hospital, Public Institution
  • Vilnius, Lithuania, 08661
    • Vilnius UH Santariskiu Clinics
• Netherlands
  • Enschede, Netherlands, 7512 AV
    • Medisch Spectrum Twente
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden
• Philippines
  • Lipa City, Philippines, 4217
    • Mary Mediatrix Medical Center
  • Lipa City, Philippines, 4217
    • Lipa Medix Medical Center
  • Manila, Philippines, 1122
    • Medical Center Manila
  • Pampanga, Philippines, 2023
    • The Medical City Clark, Mabalacat
  • Quezon City, Philippines, 1102
    • St. Luke's Medical Center
  • Quezon City, Philippines, 1118
    • Far Eastern University - Dr. Nicanor Reyes Medical Foundation
  • La Union
    • San Fernando City, La Union, Philippines, 2500
      • Ilocos Training and Regional Medical Center
  • National Capital Region
    • Makati City, National Capital Region, Philippines, 1218
      • Ospital Ng Makati
• Poland
  • Bialystok, Poland, 15 351
    • ZDROWIE Osteo Medic
  • Elblag, Poland, 82 300
    • Centrum Kliniczno Badawcze
  • Katowice, Poland, 40282
    • Silmedic sp. z o. o
  • Lubin, Poland, 20607
    • Reumed Spolka z o o
  • Lublin, Poland, 21-362
    • KO-MED Centra Kliniczne
  • Nowa Sól, Poland, 67 100
    • Twoja Przychodnia NCM
  • Olsztyn, Poland, 10 117
    • ETYKA Osrodek Badan Klinicznyc
  • Opole, Poland, 45 819
    • TPO Centrum Medyczne
  • Poznan, Poland, 61 113
    • Ai Centrum Medyczne
  • Poznan, Poland, 60529
    • Solumed Medical Center
  • Poznan, Poland, 61 293
    • Twoja Przychodnia PCM
  • Staszów, Poland, 28 200
    • KO-MED Centra Kliniczne
  • Torun, Poland, 87 100
    • MICS Medical Center Torun
  • Warsaw, Poland, 00 874
    • MICS Centrum Medyczne
  • Warsaw, Poland, 02 637
    • Instytut Reumatologii im. Eleonory Reicher
  • Warsaw, Poland, 02 793
    • Etg Warszawa
  • Warsaw, Poland, 02665
    • Klinika Reuma Park
  • Wroclaw, Poland, 50 088
    • FutureMeds Wroclaw
• Romania
  • Bacau, Romania, 600114
    • Sj de Urgenta Bacau
  • Brasov, Romania, 500283
    • S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
  • Bucharest, Romania, 14142
    • SC Delta Health Care SRL
  • Cluj-Napoca, Romania, 400006
    • Spitalul Clinic Județean de Urgență
  • Constanța, Romania, 900612
    • Aqua Med Consulting SRL
  • Craiova, Romania, 200347
    • SC Medisof Diagnostic SRL
  • Iași, Romania, 700023
    • Centrul Medical Unirea SRL
  • Râmnicu Vâlcea, Romania, 240762
    • SC Medaudio Optica SRL
  • Târgu Mureş, Romania, 540136
    • S.C Centrul Medical Unirea SR
• South Africa
  • Kempton Park, South Africa, 1619
    • Clinresco Centres Pty Ltd,
  • Pinelands, South Africa, 7405
    • Arthritis Clinical Trial Centre
  • Pretoria, South Africa, 0002
    • Emmed Research
  • Stellenbosch, South Africa, 7600
    • Winelands Medical Research Centre
• South Korea
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 04763
    • Hanyang University Seoul Hospital
• Spain
  • Alicante, Spain, 03570
    • Hospital Marina Baixa
  • Barcelona, Spain, 08208
    • UH Parc Tauli
  • Bilbao, Spain, 48013
    • Hospital Universitario Basurto
  • Córdoba, Spain, 14004
    • HU Reina Sofia
  • Madrid, Spain, 28 046
    • Hospital Universitario La Paz
  • Santander, Spain, 39008
    • HU Marqués de Valdecilla
  • Santiago de Compostela, Spain, 15702
    • Clínica Gaias Santiago
  • Seville, Spain, 41009
    • HU Virgen Macarena
  • Seville, Spain, 41014
    • UH Virgen de Valme
• Taiwan
  • Kaohsiung City, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Kaohsiung City, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital Bath NHS Foundation Trust
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk & Norwich University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key 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.

Key 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Filgotinib; Tablets administered orally once daily; Other Names: GS-6034; GLPG0634; Drug: Placebo; Tablets administered orally once daily
Experimental: 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.	Drug: Filgotinib; Tablets administered orally once daily; Other Names: GS-6034; GLPG0634; Drug: Placebo; Tablets administered orally once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), TE Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation at Week 16	Week 16

Collaborators and Investigators

• Sponsor: Alfasigma S.p.A.
• Investigators: Study Director: Alfasigma Study Director, Alfasigma S.p.A.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Actual): September 4, 2024
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: chronic inflammatory disease
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylarthritis; Spondylitis; Axial Spondyloarthritis; GLPG0634
• Other Study ID Numbers: GLPG0634-CL-336; 2022-501354-10-01 (Ctis: CTIS - euclinicaltrials.eu)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No