A Clinical Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Ulcerative Pyoderma Gangrenosum

This study was designed to assess the therapeutic efficacy and safety of SHR-1139 Injection in adult patients with ulcerative pyoderma gangrenosum.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Furen Zhang; Phone Number: 15854179852; Email: splcsy@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Dermatology Hospital Affiliated to Shandong First Medical University
      • Contact: Furen Zhang; Phone Number: 15854179852; Email: splcsy@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).
• Diagnosed with ulcerative PG during screening, and requiring systemic treatment as assessed by the investigator.
• At screening and baseline, there is at least one measurable PG ulcer. If a subject has more than one PG ulcer, the investigator will select the target PG ulcer.
• Subjects voluntarily sign informed consent form (ICF) prior to the commencement of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical study protocol.
• Adequate organ and bone marrow function.
• Female subjects of childbearing potential or male subjects whose partners are females of childbearing potential shall have no plans for childbearing, sperm/egg donation from the time of signing the informed consent form until 72 weeks after the last dose, and shall voluntarily adopt effective contraceptive measures (including their partners). Female subjects must have a negative pregnancy test result during the screening period and before randomization and drug administration, and must not be breastfeeding.

Exclusion Criteria:

• At screening, the clinical manifestations are other ulcers or other similar skin lesions caused by non-PG diseases;
• There is a significant medical history or underlying disease that affects safety.
• A history of allergy to the study drug or any component of the study drug before screening.
• A history of alcohol abuse or illegal drug abuse within one year before screening;
• Having donated approximately 500 mL of blood within 8 weeks before baseline or having plans to donate blood during the study.
• Other circumstances that the investigator judges may affect the evaluation of the safety and efficacy of the study drug.

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	Time Frame
The proportion of subjects whose target PG ulcer achieves complete closure (100% reduction in PG area, PGAR-100) at Week 12.	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects whose target PG ulcer achieves 50% closure (50% reduction in PG area, PGAR-50) at Week 12	Week 12
The proportion of subjects whose target PG ulcer achieves complete closure (100% reduction in PG area, PGAR-100) at any time point before Week 26;	up to Week 26
adverse events(AEs)	up to Week 48

Collaborators and Investigators

• Sponsor: Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: January 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: PG-IIT-SHR1139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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