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A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum

A Phase II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 Injection in Adult Patients With Pyoderma Gangrenosum

NCT07444684•Guangdong Hengrui Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥18 years at the time of signing the informed consent form, regardless of gender;
•2. Confirmed as having ulcerative pyoderma gangrenosum (PG) with a PARACELSUS score of ≥10 points at screening;
•3. At screening and baseline, having at least one measurable PG ulcer (defined as an ulcer with a measured area of ≥ 5 cm²);
•4. The participant voluntarily signs the informed consent form before the initiation of any study-related procedures, is able to communicate smoothly with the investigator, and understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
•5. Female participants of childbearing potential or male participants whose female partners are of childbearing potential have no plans for childbirth, sperm/egg donation from the time of signing the informed consent form, and voluntarily adopt highly effective contraceptive measures (including by the partner). Female participants must have a negative pregnancy test result during the screening period and before randomization and dosing, and must not be breastfeeding.

Exclusion Criteria

•1. Non-pyoderma gangrenosum (PG) diseases presenting with other ulcers or other similar skin lesions at screening;
•2. The measured area of the target PG ulcer exceeding 80 cm² at screening;
•3. Participants with chronic, non-inflammatory PG wounds or ulcers judged by the investigator to be unresponsive to immunosuppressive therapy at screening;
•4. Participants with active infection in the PG ulcer(s) at screening;
•5. A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases;
•6. A history of any active malignant tumor or malignant neoplasm within 5 years prior to the screening visit, except for curatively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the uterine cervix;
•7. Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.

Locations (1)

Shandong First Medical University Affiliated Dermatology Hospital

Jinan, Shandong, China

Key Dates

Start Date

March 5, 2026

Primary Completion Date

June 1, 2027

Completion Date

April 1, 2028

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Pyoderma Gangrenosum

Interventions

SHR-1139 Injection

DRUG

Contacts

Xin Gao

CONTACT

+86-0518-82342973 xin.gao.xg26@hengrui.com

Caihong Huang

CONTACT

+86-0518-82342973 caihong.huang.ch57@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum

Inclusion Criteria

Exclusion Criteria

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