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

NCT07719530 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-1139-207
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasisol

Outcome Measures

Primary Outcomes (1)

• 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).

  12th week

Secondary Outcomes (4)

• The proportion of participants who achieved a minimum improvement of at least 75% in PASI compared to the baseline (PASI 75) in the 12th week;

  12th week

• The proportion of participants who achieved a minimum improvement of at least 90% in PASI compared to the baseline (PASI 90) in the 12th week

  12th week

• The proportion of participants who achieved a sPGA response of 0 or 1 (sPGA 0/1) as assessed by the static physician in the 12th week

  12th week

• The proportion of participants who achieved a sPGA response of 0 (sPGA 0) in the 12th week

  12th week

Study Arms (2)

Treatment group A: SHR-1139 injection/placebo

EXPERIMENTAL

Drug: The SHR-1139 injection; Drug: placebo

Treatment group B: SHR-1139 injection/placebo

EXPERIMENTAL

Drug: The SHR-1139 injection; Drug: placebo

Interventions

The SHR-1139 injection DRUG

The SHR-1139 injection

Treatment group A: SHR-1139 injection/placebo; Treatment group B: SHR-1139 injection/placebo

placebo DRUG

placebo

Treatment group A: SHR-1139 injection/placebo; Treatment group B: SHR-1139 injection/placebo

Eligibility Criteria

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

You may qualify if:

• During the screening process, the body mass index (BMI = weight (kg) / height\^2 (m\^2)) was ≥ 18 kg/m\^2;
• History of plaque psoriasis for more than 6 months before randomization；
• The PASI score, sPGA score, and BSA at the screening and baseline required certain requirements;
• Participants suitable for phototherapy or systemic psoriasis treatment for moderate to severe plaque psoriasis;
• Participants voluntarily signed the informed consent before any procedures related to the study, could communicate smoothly with the researchers, understood and were willing to strictly follow the requirements of this clinical study protocol to complete the study;
• Female participants with reproductive capacity or their male partners with reproductive capacity, starting from the date of signing the informed consent until 72 weeks after the last medication, had no plans for pregnancy, sperm donation, or egg donation, and voluntarily took effective contraceptive measures. The pregnancy test results of female participants during the screening period and before random administration should be negative, and must be non-lactating.

You may not qualify if:

• The following conditions or diseases must be absent:
• The diagnosed psoriasis at the screening or baseline stage is not chronic plaque-type psoriasis;
• Has drug-induced psoriasis;
• Has other skin problems that the investigator considers would interfere with the assessment of psoriasis;
• Has concurrent other active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis, multiple sclerosis or other central demyelinating diseases, primary Sjögren's syndrome, etc.;
• Using the following drugs or participating in clinical studies:
• During the pre-baseline period, other biological agents had been used but did not meet the washout requirements.
• Has used drugs targeting the same target before the screening;
• Has received systemic psoriasis treatment drugs within the specified period before the baseline;
• Has received topical psoriasis treatment drugs within the specified period before the baseline;
• Has received phototherapy within the specified period before the baseline;
• Has participated in any clinical study of drugs or medical devices within 3 months before the baseline or within the drug's half-life period;
• Important conditions or underlying diseases that affect safety:
• The participant has a history of lymphocytic proliferative diseases;
• The participant has had any active malignant tumor or history of malignant tumor within the previous 5 years before the screening;

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Dermatology Hospital Hospital of Southern Medical University

Guangzhou, Guangzhou, 510091, China

Location

Central Study Contacts

Caihong Huang

CONTACT

020-62726806; caihong.huang.ch57@hengrui.com

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: July 17, 2026
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

CN (1)