This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
SHR-1139 injection.
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shandong, China
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.
Time frame: At any time before Week 26.
The time to relapse in participants who achieved a complete response (complete closure of all PG ulcers) before Week 26.
Time frame: Up to 64 weeks.
The time to the first achievement of PGAR-100 in the target PG ulcer before Week 26.
Time frame: At any time before Week 26.
The time to the first achievement of PGAR-100 in any measurable PG ulcer before Week 26.
Time frame: At any time before Week 26.
The time to the first achievement of PGAR-100 in all measurable PG ulcers before Week 26.
Time frame: At any time before Week 26.
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