Dysautonomia International

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.	Drug: Tulisokibart Subcutaneous (SC) administration Other names: MK-7240 PRA023
Experimental Medium-dose tulisokibart	Participants receive a medium dose of tulisokibart.	Drug: Tulisokibart Subcutaneous (SC) administration Other names: MK-7240 PRA023
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.	Drug: Tulisokibart Subcutaneous (SC) administration Other names: MK-7240 PRA023
Placebo Comparator Placebo	Participants receive a matched placebo dose and are rerandomized at week 16 to a medium or high dose of tulisokibart.	Drug: Placebo SC administration

Recruiting Locations

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)
Chandler 5289282, Arizona 5551752 85225