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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SHR-1139
  • SHR-1139 and SHR-1139 pleacebo

Treatment groups

50 Participants
are divided into 2 treatment groups