This study was designed to assess the therapeutic efficacy and safety of SHR-1139 Injection in adult patients with ulcerative pyoderma gangrenosum.
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.
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;
Single group
SHR-1139 Injection
DrugSHR-1139 Injection
The proportion of subjects whose target PG ulcer achieves complete closure (100% reduction in PG area, PGAR-100) at Week 16.
The proportion of subjects whose target PG ulcer achieves 50% closure (50% reduction in PG area, PGAR-50) at Week 16
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;
adverse events(AEs)
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