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NCT Number: NCT06875934

A Trial Comparing SHR-1139 Injection With Placebo 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, 200435, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR-1139 Injection

Drug

SHR-1139 injection.

SHR-1139 Injection Placebo

Drug

SHR-1139 injection placebo.

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.

    Time frame: At week 16.

Secondary outcomes

  1. Proportion of subjects with at least 75% improvement (PASI 75) in their PASI (Psoriasis Area and Severity Index) score from the baseline.

    Time frame: At week 16.

  2. Proportion of subjects with at least 100% improvement (PASI 100) in their PASI (Psoriasis Area and Severity Index) score from the baseline.

    Time frame: At week 16.

  3. Adverse events (AEs)

    Time frame: Up to week 64.

  4. Serum concentration of SHR-1139.

    Time frame: Up to week 64.

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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