Not Yet RecruitingPhase 2

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

China20 participantsStarted 2026-03-05

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged ≥18 years at the time of signing the informed consent form, regardless of gender;
✓. Confirmed as having ulcerative pyoderma gangrenosum (PG) with a PARACELSUS score of ≥10 points at screening;
✓. At screening and baseline, having at least one measurable PG ulcer (defined as an ulcer with a measured area of ≥ 5 cm²);
✓. 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;
✓. 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

✕. Non-pyoderma gangrenosum (PG) diseases presenting with other ulcers or other similar skin lesions at screening;
✕. The measured area of the target PG ulcer exceeding 80 cm² at screening;
✕. Participants with chronic, non-inflammatory PG wounds or ulcers judged by the investigator to be unresponsive to immunosuppressive therapy at screening;
✕. Participants with active infection in the PG ulcer(s) at screening;
✕. A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases;
✕. 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;
✕. Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.

What they're measuring

The proportion of participants who achieved PGAR-100 in the target PG ulcer at any time before Week 26, with confirmation at the next consecutive study visit (at least 2 weeks later).

Timeframe: At any time before Week 26.

Trial details

NCT IDNCT07444684

SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Xin Gao

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

View on ClinicalTrials.gov More Pyoderma Gangrenosum trials