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

NCT06875934 | Active Not Recruiting Phase 2

• 1 other identifier: SHR-1139-201
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (2)

SHR-1139 injection group

EXPERIMENTAL

Drug: SHR-1139 Injection

SHR-1139 injection placebo group

PLACEBO COMPARATOR

Drug: SHR-1139 Injection Placebo

Interventions

SHR-1139 Injection DRUG

SHR-1139 injection.

SHR-1139 injection group

SHR-1139 Injection Placebo DRUG

SHR-1139 injection placebo.

SHR-1139 injection placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).
• 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.
• 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).
• Female subjects must have negative pregnancy test results during the screening period and before randomized administration, and must be non-lactating.

You may not qualify if:

• There are other skin problems that researchers believe can interfere with the evaluation of psoriasis.
• 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.
• Had an opportunistic infection within 6 months prior to screening.
• Allergic to the ingredients or excipients of the study drug.
• The investigator determined that there were conditions that affected the safety and efficacy evaluation of the study drug.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, 200435, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: March 28, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CN (1)