A Clinical Study Evaluating the Efficacy and Safety of SH... | NCT07337564

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

NCT07337564

Sponsor

Shandong First Medical University

Status

Not yet recruiting

Last Update Posted

Jan 13, 2026Actual

Enrollment

10Estimated

Phase

Phase 2

Conditions

Pyoderma Gangrenosum

Interventions

SHR-1139 Injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2026Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Dec 17, 2025

First Submission Date that Met QC Criteria

Jan 4, 2026

First Posted Date

Jan 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2026

Last Update Posted Date

Jan 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
SHR-1139 injection group	Experimental		Drug: SHR-1139 Injection

Name	Type	Description	Arm Group Labels	Other Names
SHR-1139 Injection	Drug	SHR-1139 Injection	SHR-1139 injection group

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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;

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011711	Pyoderma
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017445	Skin Diseases, Vascular