A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
Purpose
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.
Condition
- Radiographic Axial Spondyloarthritis
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts 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 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental High-dose tulisokibart |
Participants receive a high dose of tulisokibart. |
|
|
Experimental Medium-dose tulisokibart |
Participants receive a medium dose of tulisokibart. |
|
|
Experimental Low-dose tulisokibart |
Participants receive a low dose of tulisokibart and are rerandomized at week 16 to a medium or high dose of tulisokibart. |
|
|
Placebo Comparator Placebo |
Participants receive a matched placebo dose and are rerandomized at week 16 to a medium or high dose of tulisokibart. |
|
Recruiting Locations
Chandler, Arizona 85225
Study Coordinator
480-443-8400
Flagstaff, Arizona 86001
Study Coordinator
480-443-8400
Gilbert, Arizona 85297
Study Coordinator
480-443-8400
Glendale, Arizona 85306
Study Coordinator
480-443-8400
Tucson, Arizona 85704-1140
Study Coordinator
480-443-8400
Chula Vista, California 91910
Study Coordinator
619-334-4735
Fullerton, California 92835
Study Coordinator
714-626-8610
Huntington Beach, California 92648
Study Coordinator
714-378-2440
Thousand Oaks, California 91360-3967
Study Coordinator
713-487-8680
Upland, California 91786
Study Coordinator
909-296-8700
Aventura, Florida 33180
Study Coordinator
305-932-4295
Brandon, Florida 33511
Study Coordinator
813-651-4441 Ext 243
Cooper City, Florida 33024
Study Coordinator
754-248-3589
Palmetto Bay, Florida 33157
Study Coordinator
305-300-2695
Chicago, Illinois 60661
Study Coordinator
480-443-8400
Willowbrook, Illinois 60527
Study Coordinator
630-537-1313
Rockville, Maryland 20850
Study Coordinator
301-942-7600
Kansas City, Missouri 64111
Study Coordinator
816-384-2827
St Louis, Missouri 63131
Study Coordinator
947-744-6010
Lincoln, Nebraska 68516-5497
Study Coordinator
402-420-3442
Santa Fe, New Mexico 87505
Study Coordinator
505-490-5984
Duncansville, Pennsylvania 16635
Study Coordinator
814-693-0300
Philadelphia, Pennsylvania 19104
Study Coordinator
215-662-2454
Murfreesboro, Tennessee 37128
Study Coordinator
615-236-2504
Arlington, Texas 76012
Study Coordinator
214-540-0700
Corpus Christi, Texas 78415
Study Coordinator
361-400-7700
Fort Worth, Texas 76109
Study Coordinator
301-942-7600
Houston, Texas 77027
Study Coordinator
346-735-8990
Irving, Texas 75039
Study Coordinator
301-942-7600
Red Oak, Texas 75154
Study Coordinator
972-777-6956
The Woodlands, Texas 77382
Study Coordinator
936-681-4882
Tomball, Texas 77375
Study Coordinator
346-550-9559
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
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.