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NOT YET RECRUITING
NCT07758075
PHASE2

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

Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Randomized, Double-blind, Dose-parallel-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Plaque Psoriasis Who Have Poor Response to Biological Agents

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-08

Completion Date

2028-05

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

DRUG

SHR-1139

Subcutaneous injection of SHR-1139

DRUG

SHR-1139 and SHR-1139 pleacebo

Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo

Locations (1)

Xiangya Hospital of Central South University

Changsha, Hunan, China