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

NCT07444684 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-1139-203
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pyoderma Gangrenosum

Outcome Measures

Primary Outcomes (1)

• 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).

  PGAR-100: 100% reduction in pyoderma gangrenosum (PG) ulcer area, i.e., complete ulcer closure.

  At any time before Week 26.

Secondary Outcomes (4)

• The time to relapse in participants who achieved a complete response (complete closure of all PG ulcers) before Week 26.

  Up to 64 weeks.

• The time to the first achievement of PGAR-100 in the target PG ulcer before Week 26.

  At any time before Week 26.

• The time to the first achievement of PGAR-100 in any measurable PG ulcer before Week 26.

  At any time before Week 26.

• The time to the first achievement of PGAR-100 in all measurable PG ulcers before Week 26.

  At any time before Week 26.

Study Arms (1)

SHR-1139 Injection Group

EXPERIMENTAL

Drug: SHR-1139 Injection

Interventions

SHR-1139 Injection DRUG

SHR-1139 injection.

SHR-1139 Injection Group

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, 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Shandong First Medical University Affiliated Dermatology Hospital

Jinan, Shandong, 250022, China

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Central Study Contacts

Xin Gao

CONTACT

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

Caihong Huang

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CN (1)