A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.
Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat Psoriatic Arthritis (PsA). This study will help find out if a study medicine called tulisokibart (MK-7240) can treat symptoms of active PsA. This study assesses the efficacy, safety, and tolerability of tulisokibart in adult participants with active PsA. In this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen PsA 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 112-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and a 72-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 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 arthr…
Interventions
- DrugTulisokibart
Subcutaneous administration
- DrugPlacebo
Subcutaneous administration
Locations (6)
- Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120)Tucson, Arizona
- Arthritis and Rheumatism Associates - Rockville ( Site 5127)Rockville, Maryland
- Altoona Center for Clinical Research ( Site 5110)Duncansville, Pennsylvania
- Articularis Healthcare Group dba: Low Country Rheumatology ( Site 5128)Summerville, South Carolina
- Greater Houston Rheumatology ( Site 5103)Houston, Texas
- Centre de Recherche Musculo-Squelettique ( Site 5202)Trois-Rivières, Quebec