A Multicenter, Randomized, Double-blind, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Moderate to Severe Plaque Psoriasis
This study is a randomized, double-blind, multi-center, parallel, phase II clinical trial, aiming to evaluate the efficacy and safety of SHR-1139 injection for adult patients with psoriasis. The trial includes a 4-week screening period, a 52-week treatment period, and a 12-week safety follow-up period. Approximately 60 patients with psoriasis are expected to participate.
• During the screening process, the body mass index (BMI = weight (kg) / height\^2 (m\^2)) was ≥ 18 kg/m\^2;
• History of plaque psoriasis for more than 6 months before randomization；
• The PASI score, sPGA score, and BSA at the screening and baseline required certain requirements;
• Participants suitable for phototherapy or systemic psoriasis treatment for moderate to severe plaque psoriasis;
• Participants voluntarily signed the informed consent before any procedures related to the study, could communicate smoothly with the researchers, understood and were willing to strictly follow the requirements of this clinical study protocol to complete the study;
• Female participants with reproductive capacity or their male partners with reproductive capacity, starting from the date of signing the informed consent until 72 weeks after the last medication, had no plans for pregnancy, sperm donation, or egg donation, and voluntarily took effective contraceptive measures. The pregnancy test results of female participants during the screening period and before random administration should be negative, and must be non-lactating.