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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pyoderma Gangrenosum
• Intervention / Treatment: Drug: SHR-1139 Injection

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xin Gao; Phone Number: +86-0518-82342973; Email: xin.gao.xg26@hengrui.com
• Study Contact Backup: Name: Caihong Huang; Phone Number: +86-0518-82342973; Email: caihong.huang.ch57@hengrui.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250022
      • Shandong First Medical University Affiliated Dermatology Hospital
      • Principal Investigator: Furen Zhang
      • Contact: Furen Zhang; Phone Number: +86-0531-87298808; Email: zhangfurenlcsy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1139 Injection Group	Drug: SHR-1139 Injection; SHR-1139 injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): March 5, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin Diseases, Vascular; Skin and Connective Tissue Diseases; Pyoderma; Pyoderma Gangrenosum
• Other Study ID Numbers: SHR-1139-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No