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

NCT07758075 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Guangdong Hengrui Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-07-31
Completion
2028-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758075 on ClinicalTrials.gov