This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.
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;
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;
Single group
SHR-1139 Injection
DrugSHR-1139 injection.
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.
The time to relapse in participants who achieved a complete response (complete closure of all PG ulcers) before Week 26.
The time to the first achievement of PGAR-100 in the target PG ulcer before Week 26.
The time to the first achievement of PGAR-100 in any measurable PG ulcer before Week 26.
The time to the first achievement of PGAR-100 in all measurable PG ulcers before Week 26.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
