Phase II Clinical Trial of SHR-1139 Injection in Patients With Psoriasis
ConditionPsoriasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
During the screening process, the body mass index (BMI = weight (kg) / height² (m²)) was ≥ 18 kg/m²;
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;
Disqualifiers
The diagnosed psoriasis at the screening or baseline stage is not chronic plaque-type psoriasis;
Has drug-induced psoriasis;
Has other skin problems that the investigator considers would interfere with the assessment of psoriasis;
Has concurrent other active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis, multiple sclerosis or other central demyelinating diseases, primary Sjögren's syndrome, etc.;
Trial design
Treatments tested in this trial
- The SHR-1139 injection
- placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov