Recruiting NCT07133633
A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tulisokibart, Placebo.
- Who it may be relevant to
- Registry conditions: Radiographic Axial Spondyloarthritis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil, Canada, Chile, China +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
Overview
Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays. This study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart. Researchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
Detailed description
This study consists of a 16-week Placebo-controlled Period and a 124-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and an 84-week Optional Extension.
Interventions
- Drug Tulisokibart
Subcutaneous (SC) administration - Drug Placebo
SC administration
Primary outcome measures
- Percentage of Participants Achieving Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 16 [Time frame: Week 16]
Secondary outcome measures (12)
- Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 at Week 16 [Time frame: Week 16]
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16 [Time frame: Baseline and Week 16]
- Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Spine at Week 16 [Time frame: Baseline and Week 16]
- Change From Baseline in the SPARCC MRI Score for Sacroiliac Joint (SIJ) at Week 16 [Time frame: Baseline and Week 16]
- Change From Baseline in Total Spinal Pain Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 at Week 16 [Time frame: Baseline and Week 16]
- Change From Baseline in Nocturnal Spinal Pain at Week 16 [Time frame: Baseline and Week 16]
- Change From Baseline in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) at Week 16 [Time frame: Baseline and Week 16]
- Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 [Time frame: Baseline and Week 16]
- Change From Baseline in BASDAI at Week 16 [Time frame: Baseline and Week 16]
- Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 16 in the Subgroup of Participants With Enthesitis (MASES>0) at Baseline [Time frame: Baseline and Week 16]
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index Linear (BASMI lin) at Week 16 [Time frame: Baseline and Week 16]
- Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) at Week 16 [Time frame: Baseline and Week 16]
Eligibility criteria
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
- Has a clinical diagnosis of axial spondyloarthritis (axSpA) and meets the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA including ≥3 months of back pain with age at symptom onset <45 years
- Meets the radiographic criterion of the modified New York criteria for ankylosing spondylitis (AS) as determined by central reading at Screening
- Has active disease at Screening and Randomization
- Has a history of inadequate response (IR)/intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) and is biologic disease-modifying antirheumatic drug (bDMARD)-naive, or has a history of IR/intolerance to up to a maximum of 2 bDMARD classes
Exclusion criteria
The main exclusion criteria include but are not limited to the following:
- Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than radiographic axial spondyloarthritis (r-axSpA) (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis (PsA), systemic sclerosis, myositis, etc.), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of r-axSpA
- Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
- Has any active infection
- Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 35 centers
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 003 — Chandler
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 00 — Flagstaff
- Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022) — Gilbert
- AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056) — Glendale
- Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025) — Tucson
- TriWest Research Associates - Chula Vista ( Site 0013) — Chula Vista
- Providence Medical Foundation ( Site 0049) — Fullerton
- Newport Huntington Medical Group ( Site 0005) — Huntington Beach
- … and 27 more centers
China · 9 centers
- The First Afflilated Hospital of Bengbu Medical College ( Site 3119) — Bengbu
- Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100) — Beijing
- Guangdong Provincial People's Hospital ( Site 3110) — Guangzhou
- The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114) — Guangzhou
- The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121) — Luoyang
- Pingxiang People's Hospital ( Site 3115) — Pingxiang
- The First Hospital Of Jilin University ( Site 3103) — Changchun
- PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124) — Ürümqi
- … and 1 more center
Ukraine · 9 centers
Center list to be confirmed — check the primary protocol.
Germany · 7 centers
- Medicover München Ost MVZ ( Site 0611) — Munich
- Rheuma-Research Lausitz ( Site 0609) — Cottbus
- Rheumazentrum Ruhrgebiet ( Site 0600) — Herne
- Rheumazentrum Ratingen Studienambulanz ( Site 0602) — Ratingen
- Rheumatologische Schwerpunktpraxis ( Site 0605) — Berlin
- Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gast — Berlin
- HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin — Hamburg
Taiwan · 7 centers
- Taipei Medical University Shuang Ho Hospital ( Site 2900) — New Taipei City
- National Taiwan University Hospital ( Site 2902) — Taipei City
- … and 5 more centers
Poland · 6 centers
- MICS Centrum Medyczne Bydgoszcz ( Site 1206) — Bydgoszcz
- Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy ( Site 1203) — Bydgoszcz
- MICS Centrum Medyczne Torun ( Site 1202) — Torun
- Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1201) — Lublin
- MICS Centrum Medyczne Warszawa ( Site 1204) — Warsaw
- Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartansk — Warsaw
Turkey (Türkiye) · 6 centers
Center list to be confirmed — check the primary protocol.
Brazil · 5 centers
- CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999) — Juiz de Fora
- Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991) — Curitiba
- LMK Serviços Médicos S/S ( Site 2000) — Porto Alegre
- IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994) — Rio de Janeiro
- Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992) — São Paulo
Chile · 5 centers
- Bioreuma ( Site 2109) — Concepción
- Clinica Alemana Osorno ( Site 2114) — Osorno
- Centro de Estudios GyC ( Site 2103) — Santiago
- Enroll SpA ( Site 2101) — Santiago
- Bradfordhill ( Site 2110) — Santiago
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Colombia · 3 centers
- Clinica de la Costa S.A.S. ( Site 2202) — Barranquilla
- CIREEM SAS ( Site 2204) — Bogota
- Fundación Valle del Lili ( Site 2201) — Cali
Netherlands · 3 centers
- Zuyderland Medical Centre ( Site 1100) — Heerlen
- Amsterdam UMC ( Site 1101) — Amsterdam
- Maasstad Ziekenhuis ( Site 1102) — Rotterdam
South Korea · 3 centers
- Kyung Hee University Hospital ( Site 2803) — Seoul
- Hanyang University Seoul Hospital ( Site 2800) — Seoul
- Kyung Hee University Hosptial at Gangdong ( Site 2802) — Seoul
Canada · 2 centers
- G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200) — Québec
- Centre de Recherche Musculo-Squelettique ( Site 0202) — Trois-Rivières
Identifiers
NCT: NCT07133633 · 7240-013 · 2025-521059-21-00 · U1111-1318-5807 · MK-7240-013