Phase II Clinical Trial of SHR-1139 Injection in Patients With Psoriasis

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT07719530
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The SHR-1139 injection — DRUG
    The SHR-1139 injection
  • placebo — DRUG
    placebo

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Aug 4, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A: SHR-1139 injection/placebo
  • Experimental: Treatment group B: SHR-1139 injection/placebo

Primary Outcome Measure

The proportion of participants who achieved a 100% improvement in the Psoriasis Area and Severity Index (PASI) score compared to the baseline by the 12th week (PASI 100). [ Time Frame: 12th week ]

Central Contacts

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