AzTrials
AzTrials

Axial SpondyloarthritisPhase 3OLINGUITONCT05785611

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

A Phase 3 study testing Filgotinib in people with Axial Spondyloarthritis, run by Alfasigma S.p.A. at 123 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Axial Spondyloarthritis
What is being tested?
Filgotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
495 participants
Where
123 sitesin 18 countries
Study dates
5 Apr 2023to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 21Show fewer
  • 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.
  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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).

Trial locations and contacts

123 sites in 18 countries.

123 sites in 18 countries

Poland18 sites

  • ZDROWIE Osteo Medic

    Bialystok, 15 351

  • Centrum Kliniczno Badawcze

    Elblag, 82 300

  • Silmedic sp. z o. o

    Katowice, 40282

  • Reumed Spolka z o o

    Lubin, 20607

  • KO-MED Centra Kliniczne

    Lublin, 21-362

  • Twoja Przychodnia NCM

    Nowa Sól, 67 100

  • ETYKA Osrodek Badan Klinicznyc

    Olsztyn, 10 117

  • TPO Centrum Medyczne

    Opole, 45 819

  • Solumed Medical Center

    Poznan, 60529

  • AI Centrum Medyczne

    Poznan, 61 113

  • Twoja Przychodnia PCM

    Poznan, 61 293

  • KO-MED Centra Kliniczne

    Staszów, 28 200

  • MICS Medical Center Torun

    Torun, 87 100

  • MICS Centrum Medyczne

    Warsaw, 00 874

  • Instytut Reumatologii im. Eleonory Reicher

    Warsaw, 02 637

  • ETG Warszawa

    Warsaw, 02 793

  • Klinika Reuma Park

    Warsaw, 02665

  • FutureMeds Wroclaw

    Wroclaw, 50 088

Other trials in Poland

Bulgaria16 sites

  • Medical Center Rodopimed

    Kardzhali, 6600

  • MC Medconsult Pleven

    Pleven, 5800

  • UMHAT Plovdiv AD

    Plovdiv, 4003

  • UMHAT Eurohospital Plovdiv

    Plovdiv, 4004

  • Medical Center UNIMED EOOD

    Plovdiv, 4023

  • Medical Center Teodora

    Rousse, 7000

  • Medical Center 1 Sevlievo

    Sevlievo, 5400

  • DCC Ascendent EOOD

    Sofia, 1202

  • UMHAT Sofiamed OOD

    Sofia, 1336

  • Dcc Focus 5 Meoh Ood

    Sofia, 1463

  • Dcc Focus 5 Meoh

    Sofia, 1463

  • DCC XVII-Sofia EOOD

    Sofia, 1505

  • Medical Center Hera

    Sofia, 1510

  • Medical Center N I PIROGOV

    Sofia, 1606

  • Military Medical Academy MHAT

    Sofia, 1606

  • UMHAT Stoyan Kirkovich AD

    Stara Zagora, 6003

Other trials in Bulgaria

Czechia14 sites

  • Fakultni nemocnice u sv Anny, Interni klinika

    Brno, 60 200

  • Revmaclinic s r o

    Brno, 60 200

  • Lekarna BENU

    Brno, 602 00

  • Revmatologie s r o

    Brno, 638 00

  • CCR Ostrava

    Ostrava, 70 200

  • Vesalion Revma ambulance

    Ostrava, 70 200

  • Artroscan s r o

    Ostrava, 722 00

  • ARTHROHELP s r o

    Pardubice, 530 02

  • CCR Czech a s

    Pardubice, 530 02

  • Lekarna U Revmatologickeho

    Prague, Nove Mesto, 12800

  • MUDR. Zuzana URBANOVA Revmatologie

    Prague, 12800

  • Fakultni nemocnice Motol

    Prague, 150 06

  • Medical Plus Sro

    Uherské Hradiště, 68601

  • PV Medical Services

    Zlín, 76001

Other trials in Czechia

Romania9 sites

  • Sj de Urgenta Bacau

    Bacau, 600114

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

    Brasov, 500283

  • SC Delta Health Care SRL

    Bucharest, 14142

  • Spitalul Clinic Judetean de Urgenta

    Cluj-Napoca, 400006

  • Aqua Med Consulting SRL

    Constanța, 900612

  • SC Medisof Diagnostic SRL

    Craiova, 200347

  • Centrul Medical Unirea SRL

    Iași, 700023

  • Sc Medaudio Optica Srl

    Râmnicu Vâlcea, 240762

  • S.C Centrul Medical Unirea SR

    Târgu Mureş, 540136

Other trials in Romania

Spain9 sites

  • Hospital Marina Baixa

    Alicante, 03570

  • UH Parc Tauli

    Barcelona, 08208

  • Hospital Universitario Basurto

    Bilbao, 48013

  • HU Reina Sofia

    Córdoba, 14004

  • Hospital Universitario La Paz

    Madrid, 28 046

  • HU Marques de Valdecilla

    Santander, 39008

  • Clinica GAIAS Santiago

    Santiago de Compostela, 15702

  • HU Virgen Macarena

    Seville, 41009

  • UH Virgen de Valme

    Seville, 41014

Other trials in Spain

Philippines8 sites

  • Lipa Medix Medical Center

    Lipa City, 4217

  • Mary Mediatrix Medical Center

    Lipa City, 4217

  • Ospital Ng Makati

    Makati City, National Capital Region, 1218

  • Medical Center Manila

    Manila, 1122

  • The Medical City Clark, Mabalacat

    Pampanga, 2023

  • St. Luke's Medical Center

    Quezon City, 1102

  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation

    Quezon City, 1118

  • Ilocos Training and Regional Medical Center

    San Fernando City, La Union, 2500

Other trials in Philippines

Italy6 sites

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Naples, 80138

  • Policlinico Paolo Giaccone

    Palermo, 90127

  • Policlinico Uni Campus Bio-Med

    Rome, 00128

  • Policlinico Universitario Agostino Gemelli

    Rome, 00168

  • Ospedale SM Misericordia

    Udine, 33100

Other trials in Italy

South Korea6 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Hospital

    Seoul, 03080

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Konkuk University Medical Center

    Seoul, 05030

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

Other trials in South Korea

Belgium5 sites

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels, 1070

  • ReumaClinic

    Genk, 3600

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHU Helora

    Mons, 7000

Other trials in Belgium

France5 sites

  • APHP Hopital Ambroise Pare

    Boulogne-Billancourt, 92100

  • Hopital Edouard Herriot

    Lyon, 69003

  • CHR d'Orleans

    Orléans, 45100

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Charles Nicolle

    Rouen, 76000

Other trials in France

Germany5 sites

  • Charite Medizinische Klinik I

    Berlin, 12203

  • Hamburger Rheuma II

    Hamburg, 20095

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Klinische Forschung im med

    Planegg, 82152

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Hungary5 sites

  • Revita Rheumatologiai Kft

    Budapest, 1027

  • University of Debrecen

    Debrecen, 4032

  • Reumatologiai es Immunologiai

    Pécs, 7632

  • Vita Verum Medical

    Székesfehérvár, 8000

  • Obudai Egeszsegugyi Centrum

    Zalaegerszeg, 8900

Other trials in Hungary

Lithuania4 sites

  • Kaunas Hospital of LUHSCP

    Kaunas, 45130

  • Kaunas City Polyclinic

    Kaunas, 51270

  • Klaipeda University Hospital, Public Institution

    Klaipėda, 92288

  • Vilnius UH Santariskiu Clinics

    Vilnius, 08661

Other trials in Lithuania

South Africa4 sites

  • Clinresco Centres Pty Ltd,

    Kempton Park, 1619

  • Arthritis Clinical Trial Centre

    Pinelands, 7405

  • Emmed Research

    Pretoria, 0002

  • Winelands Medical Research Centre

    Stellenbosch, 7600

Other trials in South Africa

Taiwan3 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • Taipei Medical University Hospital

    Taipei, 110

Other trials in Taiwan

Estonia2 sites

  • Clinical Research Centre

    Tartu, 50106

  • Meditrials OU

    Tartu, 50708

Other trials in Estonia

Netherlands2 sites

  • Medisch Spectrum Twente

    Enschede, 7512 AV

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

Other trials in Netherlands

United Kingdom2 sites

  • Royal United Hospital Bath NHS Foundation Trust

    Bath, BA1 3NG

  • Norfolk & Norwich University Hospital

    Norwich, NR4 7UY

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Filgotinib, Placebo
Keywords
chronic inflammatory disease
Medical subject headings
Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FilgotinibDrug

    Also called GS-6034, GLPG0634

    Tablets administered orally once daily

  • PlaceboDrug

    Tablets administered orally once daily

Study groups in NCT05785611
Study groupRoleWhat they receive
Radiographic Part (Study A) FilgotinibExperimentalParticipants 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.
Receives: Drug: Filgotinib; Drug: Placebo
Non-radiographic Part (Study B) FilgotinibExperimentalParticipants 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.
Receives: Drug: Filgotinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 16

Secondary outcomes (6)

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

    Measured: Week 16

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

    Measured: Week 16

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

    Measured: Week 16

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

    Measured: Week 16

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

    Measured: Week 16

  6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), TE Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation at Week 16

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study start5 Apr 2023
  3. Primary completion4 Sep 2024
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05785611
Sponsor's protocol ID
GLPG0634-CL-336
Other IDs
2022-501354-10-01
Acronym
OLINGUITO
Status last verified
Dec 2025
First submitted
14 Mar 2023
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.

    PubMed 41039829

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Filgotinib in people with Axial Spondyloarthritis, run by Alfasigma S.p.A. at 123 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in Poland, Bulgaria, Czechia, Romania, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving SpondyloArthritis International Society 40% improvement (ASAS40) Response (Yes/No) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05785611, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in