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)
Merck Sharp & Dohme LLC
Summary
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.
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 nonst…
Interventions
- DrugTulisokibart
Subcutaneous (SC) administration
- DrugPlacebo
SC administration
Locations (95)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)Chandler, Arizona
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)Flagstaff, Arizona
- Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)Gilbert, Arizona
- AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)Glendale, Arizona
- Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)Tucson, Arizona
- TriWest Research Associates - Chula Vista ( Site 0013)Chula Vista, California