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New pill could ease stiff back pain for thousands

NCT ID NCT05785611

Disease control Sponsor: Alfasigma S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether the drug filgotinib, taken as a daily pill, can reduce symptoms of active axial spondyloarthritis—a type of arthritis that causes back pain and stiffness. About 495 adults with the condition will receive either filgotinib (200 mg or 100 mg) or a placebo. The main goal is to see if more people on the drug achieve a 40% improvement in symptoms by week 16.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Filgotinib (a drug taken as a daily pill)
What this could lead to
If it works, this could provide a new daily pill option to control symptoms and slow disease activity in axial spondyloarthritis.
What could go wrong
This is a late-stage trial, but results may not apply to all patients. Risks include infections and other side effects common with this class of drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

495 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Axial Spondyloarthritis spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axial spondyloarthritis

Contacts and locations

Locations

  • AI Centrum Medyczne

    Poznan, 61 113, Poland

  • APHP Hopital Ambroise Pare

    Boulogne-Billancourt, 92100, France

  • ARTHROHELP s r o

    Pardubice, 530 02, Czechia

  • Aqua Med Consulting SRL

    Constanța, 900612, Romania

  • Arthritis Clinical Trial Centre

    Pinelands, 7405, South Africa

  • Artroscan s r o

    Ostrava, 722 00, Czechia

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Naples, 80138, Italy

  • CCR Czech a s

    Pardubice, 530 02, Czechia

  • CCR Ostrava

    Ostrava, 70 200, Czechia

  • CHR d'Orleans

    Orléans, 45100, France

  • CHU Helora

    Mons, 7000, Belgium

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centrul Medical Unirea SRL

    Iași, 700023, Romania

  • Centrum Kliniczno Badawcze

    Elblag, 82 300, Poland

  • Charite Medizinische Klinik I

    Berlin, 12203, Germany

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Clinica GAIAS Santiago

    Santiago de Compostela, 15702, Spain

  • Clinical Research Centre

    Tartu, 50106, Estonia

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels, 1070, Belgium

  • Clinresco Centres Pty Ltd,

    Kempton Park, 1619, South Africa

  • DCC Ascendent EOOD

    Sofia, 1202, Bulgaria

  • DCC XVII-Sofia EOOD

    Sofia, 1505, Bulgaria

  • Dcc Focus 5 Meoh

    Sofia, 1463, Bulgaria

  • Dcc Focus 5 Meoh Ood

    Sofia, 1463, Bulgaria

  • ETG Warszawa

    Warsaw, 02 793, Poland

  • ETYKA Osrodek Badan Klinicznyc

    Olsztyn, 10 117, Poland

  • Emmed Research

    Pretoria, 0002, South Africa

  • Fakultni nemocnice Motol

    Prague, 150 06, Czechia

  • Fakultni nemocnice u sv Anny, Interni klinika

    Brno, 60 200, Czechia

  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation

    Quezon City, 1118, Philippines

  • FutureMeds Wroclaw

    Wroclaw, 50 088, Poland

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273, South Korea

  • HU Marques de Valdecilla

    Santander, 39008, Spain

  • HU Reina Sofia

    Córdoba, 14004, Spain

  • HU Virgen Macarena

    Seville, 41009, Spain

  • Hamburger Rheuma II

    Hamburg, 20095, Germany

  • Hanyang University Seoul Hospital

    Seoul, 04763, South Korea

  • Hopital Charles Nicolle

    Rouen, 76000, France

  • Hopital Edouard Herriot

    Lyon, 69003, France

  • Hospital Marina Baixa

    Alicante, 03570, Spain

  • Hospital Universitario Basurto

    Bilbao, 48013, Spain

  • Hospital Universitario La Paz

    Madrid, 28 046, Spain

  • Ilocos Training and Regional Medical Center

    San Fernando City, La Union, 2500, Philippines

  • Instytut Reumatologii im. Eleonory Reicher

    Warsaw, 02 637, Poland

  • Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

  • KO-MED Centra Kliniczne

    Lublin, 21-362, Poland

  • KO-MED Centra Kliniczne

    Staszów, 28 200, Poland

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • Kaunas City Polyclinic

    Kaunas, 51270, Lithuania

  • Kaunas Hospital of LUHSCP

    Kaunas, 45130, Lithuania

  • Klaipeda University Hospital, Public Institution

    Klaipėda, 92288, Lithuania

  • Klinika Reuma Park

    Warsaw, 02665, Poland

  • Klinische Forschung im med

    Planegg, 82152, Germany

  • Konkuk University Medical Center

    Seoul, 05030, South Korea

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • Lekarna BENU

    Brno, 602 00, Czechia

  • Lekarna U Revmatologickeho

    Prague, Nove Mesto, 12800, Czechia

  • Lipa Medix Medical Center

    Lipa City, 4217, Philippines

  • MC Medconsult Pleven

    Pleven, 5800, Bulgaria

  • MICS Centrum Medyczne

    Warsaw, 00 874, Poland

  • MICS Medical Center Torun

    Torun, 87 100, Poland

  • MUDR. Zuzana URBANOVA Revmatologie

    Prague, 12800, Czechia

  • Mary Mediatrix Medical Center

    Lipa City, 4217, Philippines

  • Medical Center 1 Sevlievo

    Sevlievo, 5400, Bulgaria

  • Medical Center Hera

    Sofia, 1510, Bulgaria

  • Medical Center Manila

    Manila, 1122, Philippines

  • Medical Center N I PIROGOV

    Sofia, 1606, Bulgaria

  • Medical Center Rodopimed

    Kardzhali, 6600, Bulgaria

  • Medical Center Teodora

    Rousse, 7000, Bulgaria

  • Medical Center UNIMED EOOD

    Plovdiv, 4023, Bulgaria

  • Medical Plus Sro

    Uherské Hradiště, 68601, Czechia

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD, Netherlands

  • Medisch Spectrum Twente

    Enschede, 7512 AV, Netherlands

  • Meditrials OU

    Tartu, 50708, Estonia

  • Military Medical Academy MHAT

    Sofia, 1606, Bulgaria

  • Norfolk & Norwich University Hospital

    Norwich, NR4 7UY, United Kingdom

  • Obudai Egeszsegugyi Centrum

    Zalaegerszeg, 8900, Hungary

  • Ospedale SM Misericordia

    Udine, 33100, Italy

  • Ospital Ng Makati

    Makati City, National Capital Region, 1218, Philippines

  • PV Medical Services

    Zlín, 76001, Czechia

  • Policlinico Paolo Giaccone

    Palermo, 90127, Italy

  • Policlinico Uni Campus Bio-Med

    Rome, 00128, Italy

  • Policlinico Universitario Agostino Gemelli

    Rome, 00168, Italy

  • ReumaClinic

    Genk, 3600, Belgium

  • Reumatologiai es Immunologiai

    Pécs, 7632, Hungary

  • Reumed Spolka z o o

    Lubin, 20607, Poland

  • Revita Rheumatologiai Kft

    Budapest, 1027, Hungary

  • Revmaclinic s r o

    Brno, 60 200, Czechia

  • Revmatologie s r o

    Brno, 638 00, Czechia

  • Rheumazentrum Ruhrgebiet

    Herne, 44649, Germany

  • Royal United Hospital Bath NHS Foundation Trust

    Bath, BA1 3NG, United Kingdom

  • S.C Centrul Medical Unirea SR

    Târgu Mureş, 540136, Romania

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

    Brasov, 500283, Romania

  • SC Delta Health Care SRL

    Bucharest, 14142, Romania

  • SC Medisof Diagnostic SRL

    Craiova, 200347, Romania

  • Sc Medaudio Optica Srl

    Râmnicu Vâlcea, 240762, Romania

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Silmedic sp. z o. o

    Katowice, 40282, Poland

  • Sj de Urgenta Bacau

    Bacau, 600114, Romania

  • Solumed Medical Center

    Poznan, 60529, Poland

  • Spitalul Clinic Judetean de Urgenta

    Cluj-Napoca, 400006, Romania

  • St. Luke's Medical Center

    Quezon City, 1102, Philippines

  • TPO Centrum Medyczne

    Opole, 45 819, Poland

  • Taipei Medical University Hospital

    Taipei, 110, Taiwan

  • The Medical City Clark, Mabalacat

    Pampanga, 2023, Philippines

  • Twoja Przychodnia NCM

    Nowa Sól, 67 100, Poland

  • Twoja Przychodnia PCM

    Poznan, 61 293, Poland

  • UH Parc Tauli

    Barcelona, 08208, Spain

  • UH Virgen de Valme

    Seville, 41014, Spain

  • UMHAT Eurohospital Plovdiv

    Plovdiv, 4004, Bulgaria

  • UMHAT Plovdiv AD

    Plovdiv, 4003, Bulgaria

  • UMHAT Sofiamed OOD

    Sofia, 1336, Bulgaria

  • UMHAT Stoyan Kirkovich AD

    Stara Zagora, 6003, Bulgaria

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • University of Debrecen

    Debrecen, 4032, Hungary

  • Vesalion Revma ambulance

    Ostrava, 70 200, Czechia

  • Vilnius UH Santariskiu Clinics

    Vilnius, 08661, Lithuania

  • Vita Verum Medical

    Székesfehérvár, 8000, Hungary

  • Winelands Medical Research Centre

    Stellenbosch, 7600, South Africa

  • ZDROWIE Osteo Medic

    Bialystok, 15 351, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.