About this trial
This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SHR-1139 Injection