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.
Aged ≥ 18 years at the time of signing the informed consent form (ICF), male or female
Body mass index was ≥18 kg/m ² at screening
A history of plaque psoriasis ≥6 months before randomization, with or without psoriatic arthritis
Inadequate response to at least one biologic agent administered at full dose and on a regular schedule prior to screening
Diagnosis of psoriasis other than chronic plaque psoriasis at screening or baseline
Drug-induced psoriasis
Other skin conditions that, in the investigator's opinion, would interfere with psoriasis assessment
Concurrent other active autoimmune diseases
Parallel
SHR-1139
DrugSubcutaneous injection of SHR-1139
SHR-1139 and SHR-1139 pleacebo
DrugSubcutaneous injection of SHR-1139 and SHR-1139 pleacebo
The proportion of participants with a sPGA response of 0 or 1 at week 16.
The proportion of participants whose PASI score improved by at least 90% compared to the baseline in week 16 (reaching PASI 90)
The proportion of participants whose PASI score improved by at least 75% compared to the baseline in week 16 (reaching PASI 75)
The proportion of participants whose PASI score improved by at least 100% compared to the baseline in week 16 (reaching PASI 100)
The proportion of participants with a 0 sPGA response in week 16
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This trial is not recruiting at the moment. You can still explore other options:
