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A Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Plaque Psoriasis

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a randomized, double-blind, multicenter, dose-parallel-controlled phase II clinical trial. The study consists of three stages: a 4-week screening period, a 52-week treatment period, and a 12-week follow-up period. For the qualified participants screened, using body weight (≥90 kg or \< 90 kg) and whether participants had a poor response to IL-12/23p40 inhibitors in the past (yes vs no) as stratification factors, they were randomly assigned to two groups in a 1:1 ratio: Group 1 and Group 2. The evaluation of the primary study endpoint, some secondary study endpoints and some other endpoints was completed at 16 weeks. Participants who complete the 52nd week assessment will enter a 12-week safe follow-up period until the end of the study.
Trial Details
NCT Number NCT07758075
Lead Sponsor Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions Plaque Psoriasis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov