A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Patients With Moderate-to-severe Plaque Psoriasis

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 injection in patients with moderate to severe plaque psoriasis.

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: SHR-1139 Injection; Drug: SHR-1139 Injection Placebo

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200435
      • Shanghai Dermatology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).
2. Subjects voluntarily sign informed consent form (ICF) prior to the commencement of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical study protocol.
3. A fertile female subject or a male subject whose partner is a fertile woman who has not had a child, has a sperm/egg donation plan for 72 weeks from the date of signing the informed consent form to the last dose, and is voluntarily using highly effective contraception (including the partner).
4. Female subjects must have negative pregnancy test results during the screening period and before randomized administration, and must be non-lactating.

Exclusion Criteria:

1. There are other skin problems that researchers believe can interfere with the evaluation of psoriasis.
2. A history of moderate to severe congestive heart failure, cardiovascular and cerebrovascular events or severe bleeding events occurred in the 3 months before screening, and the investigator considered this subject to be unfit for clinical study.
3. Had an opportunistic infection within 6 months prior to screening.
4. Allergic to the ingredients or excipients of the study drug.
5. The investigator determined that there were conditions that affected the safety and efficacy evaluation of the study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1139 injection group	Drug: SHR-1139 Injection; SHR-1139 injection.
Placebo Comparator: SHR-1139 injection placebo group	Drug: SHR-1139 Injection Placebo; SHR-1139 injection placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with at least 90% improvement (PASI 90) in their PASI (Psoriasis Area and Severity Index) score from the baseline.	At week 16.

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with at least 75% improvement (PASI 75) in their PASI (Psoriasis Area and Severity Index) score from the baseline.	At week 16.
Proportion of subjects with at least 100% improvement (PASI 100) in their PASI (Psoriasis Area and Severity Index) score from the baseline.	At week 16.
Adverse events (AEs)	Up to week 64.
Serum concentration of SHR-1139.	Up to week 64.

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 9, 2025
• First Submitted That Met QC Criteria: March 9, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: SHR-1139-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No