Actively Recruiting
Phase 3 Study Comparing QL2106 Injection to Tremfya in Adults With Moderate to Severe Plaque Psoriasis
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-06-05
318
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of QL2106 injection compared to Tremfya in patients with moderate to severe plaque psoriasis. This Phase 3, multicenter, randomized, double-blind, parallel, and active-controlled study plans to enroll 318 participants to better understand treatment effects in this population. Participants will be randomly assigned in equal numbers to receive either QL2106 injection or Tremfya. Both treatments are given by subcutaneous injection at Week 0, Week 4, and then every 8 weeks. The recommended dose for both is 100 mg. This study uses a quadruple blinding method to maintain objectivity. Throughout the study, researchers will assess the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Index PASI-75 at Week 16. Participants will be monitored for safety and treatment response during the trial. The study is expected to continue until February 2028, with participants involved in regular visits according to the treatment schedule for assessment and care.
CONDITIONS
Brief Title
A Phase 3 Clinical Study of QL2106 Injection
Research Team
Y
Yu ling Shi, Doctor
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