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

NCT07758075 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-1139-204
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• The proportion of participants with a sPGA response of 0 or 1 at week 16.

  at week 16

Secondary Outcomes (32)

• The proportion of participants whose PASI score improved by at least 90% compared to the baseline in week 16 (reaching PASI 90)

  week 16

• The proportion of participants whose PASI score improved by at least 75% compared to the baseline in week 16 (reaching PASI 75)

  week 16

• The proportion of participants whose PASI score improved by at least 100% compared to the baseline in week 16 (reaching PASI 100)

  week 16

• The proportion of participants with a 0 sPGA response in week 16

  week 16

• The proportion of participants with a sPGA response of 0 or 1 at all other visits every four weeks, up to 64 weeks

  up to 64 weeks

Study Arms (2)

Group 1: Subcutaneous injection of SHR-1139

EXPERIMENTAL

Drug: SHR-1139

Group 2: Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo

EXPERIMENTAL

Drug: SHR-1139 and SHR-1139 pleacebo

Interventions

SHR-1139 DRUG

Subcutaneous injection of SHR-1139

Group 1: Subcutaneous injection of SHR-1139

SHR-1139 and SHR-1139 pleacebo DRUG

Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo

Group 2: Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo

Eligibility Criteria

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

You may qualify if:

• Aged ≥ 18 years at the time of signing the informed consent form (ICF), male or female
• Body mass index was ≥18 kg/m ² at screening
• A history of plaque psoriasis ≥6 months before randomization, with or without psoriatic arthritis
• Inadequate response to at least one biologic agent administered at full dose and on a regular schedule prior to screening
• tParticipants with plaque psoriasis deemed by the investigator suitable for continued biologic therapy
• Participants voluntarily sign informed consent before the start of any procedures related to the study, able to communicate smoothly with the investigator, understand and comply with the study protocol requirements

You may not qualify if:

• Diagnosis of psoriasis other than chronic plaque psoriasis at screening or baseline
• Drug-induced psoriasis
• Other skin conditions that, in the investigator's opinion, would interfere with psoriasis assessment
• Concurrent other active autoimmune diseases
• Prior exposure to drugs targeting the IL-36 receptor
• Prior exposure to drugs targeting IL-23p19
• Systemic treatment other than biological agents was received within 4 weeks before baseline
• Topical treatment for psoriasis was received within two weeks before the baseline
• Received photochemotherapy within 4 weeks before baseline, or received phototherapy within 2 weeks before baseline
• Have participated in any clinical study of a drug or medical device within 3 months prior to baseline or within 5 half-lives of the drug
• The participants had a previous history of lymphocytic hyperplasia
• Participants had any history of active malignant tumors or malignant tumors within the five years prior to screening
• Participants with a history of moderate to severe congestive heart failure, cardiovascular and cerebrovascular events, or severe bleeding events within 3 months prior to screening were considered unsuitable for clinical research by the researchers
• There was a history of opportunistic infection or immunodeficiency disease within 6 months prior to screening
• If there was an active infection within 2 weeks before baseline requiring oral anti-infection treatment, or if there was a severe infection or systemic infection within 4 weeks before baseline requiring intravenous anti-infection treatment or hospitalization due to infection, or other chronic, recurrent, and active infections that the researcher judged as unsuitable for participation in this study

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Central Study Contacts

Yijia Xu

CONTACT

0518-82342973; yijia.xu.yx309@hengrui.com

Study Design

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

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 11, 2026

Record last verified: 2026-07

Locations

CN (1)