Tulisokibart for adults with psoriatic arthritis
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.
This will test whether the medicine tulisokibart helps reduce symptoms in adults with active psoriatic arthritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 6 sites (Tucson, Arizona and 5 other locations) |
| Trial ID | NCT07486960 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial randomizes adults with active PsA to receive one of several doses of tulisokibart or a matching placebo during a 16-week placebo-controlled period to compare symptom improvement, safety, and tolerability. Participants who complete the initial period may enter a 112-week long-term extension made up of a 40-week main extension and a 72-week optional extension to collect longer-term safety and efficacy data. Eligible adults must meet CASPAR criteria with symptom onset at least six months prior and may be bDMARD‑naïve or have had an inadequate response or intolerance to bDMARDs. Key exclusions include other inflammatory joint diseases or arthritis onset before age 17 that could confound assessment.
Who should consider this trial
Good fit: Adults with active PsA who meet CASPAR criteria, have symptoms for at least six months, and are either bDMARD‑naive or have had an inadequate response or intolerance to bDMARDs.
Not a fit: Patients with inflammatory joint diseases other than PsA, disease onset before age 17, or other conditions that interfere with PsA assessment are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, tulisokibart could reduce joint and skin symptoms and improve daily function for adults with active PsA.
How similar studies have performed: Other approved biologics and targeted therapies for PsA have shown benefit, but tulisokibart is a novel agent and its effectiveness in PsA remains to be demonstrated in clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a clinical diagnosis of PsA and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening, with symptom onset ≥6 months before Screening. * Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis. * Has history of biologic disease-modifying antirheumatic drug (bDMARD)-naïve or bDMARD-inadequate response/intolerant. 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 PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of PsA. * Has a skin condition diagnosis, other than psoriasis that may, in the judgment of the investigator, interfere with the assessment of psoriasis. * Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before Randomization. * Has any active infection. * Has known allergies, hypersensitivity, or intolerance to tulisokibart of its excipients.
Where this trial is running
Tucson, Arizona and 5 other locations
- Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120) — Tucson, Arizona, United States (Recruiting)
- Arthritis and Rheumatism Associates - Rockville ( Site 5127) — Rockville, Maryland, United States (Recruiting)
- Altoona Center for Clinical Research ( Site 5110) — Duncansville, Pennsylvania, United States (Recruiting)
- Articularis Healthcare Group dba: Low Country Rheumatology ( Site 5128) — Summerville, South Carolina, United States (Recruiting)
- Greater Houston Rheumatology ( Site 5103) — Houston, Texas, United States (Recruiting)
- Centre de Recherche Musculo-Squelettique ( Site 5202) — Trois-Rivières, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.