A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis (OLINGUITO)
Axial Spondyloarthritis
About this trial
This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring chronic inflammatory disease
Eligibility Criteria
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: 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 designated as biologic disease-modifying antirheumatic drug-inadequate responder (bDMARD-IR) must have received not more than 2 approved bDMARD(s), that was/were administered in accordance with its/their labeling and was/were inadequately effective after the minimum treatment of 12 weeks. 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 vertebrae 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. 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 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).
Sites / Locations
- ReumaClinicRecruiting
- Universitair Ziekenhuis GentRecruiting
- Medical Center RodopimedRecruiting
- MC Medconsult PlevenRecruiting
- UMHAT Plovdiv ADRecruiting
- UMHAT Eurohospital PlovdivRecruiting
- Medical Center UNIMED EOODRecruiting
- Medical Center TeodoraRecruiting
- Medical Center 1 SevlievoRecruiting
- DCC Ascendent EOODRecruiting
- UMHAT Sofiamed OODRecruiting
- Dcc Focus 5 Meoh OodRecruiting
- Dcc Focus 5 MeohRecruiting
- DCC XVII-Sofia EOODRecruiting
- Medical Center HeraRecruiting
- Medical Center N I PIROGOVRecruiting
- Military Medical Academy MHATRecruiting
- UMHAT Stoyan Kirkovich ADRecruiting
- CHC Rijeka Immunology DepartmentRecruiting
- Poliklinika BonifarmRecruiting
- Poliklinika K-CentarRecruiting
- Lekarna U RevmatologickehoRecruiting
- Fakultni nemocnice u sv Anny, Interni klinikaRecruiting
- Revmaclinic s r oRecruiting
- Lekarna BENURecruiting
- Revmatologie s r oRecruiting
- CCR OstravaRecruiting
- Vesalion Revma ambulanceRecruiting
- Artroscan s r oRecruiting
- ARTHROHELP s r oRecruiting
- CCR Czech a sRecruiting
- MUDR. Zuzana URBANOVA RevmatologieRecruiting
- Fakultni nemocnice MotolRecruiting
- Medical Plus SroRecruiting
- PV Medical ServicesRecruiting
- Clinical Research CentreRecruiting
- Meditrials OURecruiting
- Centre Hospitalier Lyon SudRecruiting
- Charite Medizinische Klinik IRecruiting
- University General Hospital "Attikon"Recruiting
- Revita Rheumatologiai KftRecruiting
- Vita Verum MedicalRecruiting
- Istituto Ortopedico RizzoliRecruiting
- Chonnam National University HospitalRecruiting
- Seoul National University HospitalRecruiting
- Hanyang University Seoul HospitalRecruiting
- Konkuk University Medical CenterRecruiting
- Kyung Hee University Hospital at GangdongRecruiting
- Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
- Kaunas Hospital of LUHSCPRecruiting
- Kaunas City PolyclinicRecruiting
- Klaipeda University Hospital, Public InstitutionRecruiting
- Vilnius UH Santariskiu ClinicsRecruiting
- Medisch Spectrum TwenteRecruiting
- UMCGRecruiting
- Zuyderland Medisch CentrumRecruiting
- Medisch Centrum LeeuwardenRecruiting
- Ilocos Training and Regional Medical CenterRecruiting
- Ospital Ng MakatiRecruiting
- Lipa Medix Medical CenterRecruiting
- Mary Mediatrix Medical CenterRecruiting
- St. Luke's Medical CenterRecruiting
- Far Eastern University - Dr. Nicanor Reyes Medical FoundationRecruiting
- ZDROWIE Osteo MedicRecruiting
- Centrum Kliniczno BadawczeRecruiting
- Silmedic sp. z o. oRecruiting
- Reumed Spolka z o oRecruiting
- KO-MED Centra KliniczneRecruiting
- Twoja Przychodnia NCMRecruiting
- ETYKA Osrodek Badan KlinicznycRecruiting
- TPO Centrum MedyczneRecruiting
- AI Centrum MedyczneRecruiting
- Solumed Medical CenterRecruiting
- Twoja Przychodnia PCMRecruiting
- KO-MED Centra KliniczneRecruiting
- MICS Medical Center TorunRecruiting
- Instytut Reumatologii im. Eleonory ReicherRecruiting
- Klinika Reuma ParkRecruiting
- MICS Centrum MedyczneRecruiting
- ETG WarszawaRecruiting
- FutureMeds WroclawRecruiting
- Sj de Urgenta BacauRecruiting
- S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.LRecruiting
- SC Delta Health Care SRLRecruiting
- Spitalul Clinic Judetean de UrgentaRecruiting
- Aqua Med Consulting SRLRecruiting
- SC Medisof Diagnostic SRLRecruiting
- Sc Medaudio Optica SrlRecruiting
- Clinresco Centres Pty Ltd,Recruiting
- Arthritis Clinical Trial CentreRecruiting
- Emmed ResearchRecruiting
- Winelands Medical Research CentreRecruiting
- Hospital Marina BaixaRecruiting
- UH Parc TauliRecruiting
- HU Reina SofiaRecruiting
- Hospital Universitario La PazRecruiting
- HU Marques de ValdecillaRecruiting
- Clinica GAIAS SantiagoRecruiting
- HU Virgen MacarenaRecruiting
- Kaohsiung Veterans General HospitalRecruiting
- Kaohsiung Chang Gung Memorial HospitalRecruiting
- Taipei Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Radiographic Part (Study A) Filgotinib
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 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.
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.