Pyoderma Gangrenosum
Conditions
Brief summary
This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.
Interventions
SHR-1139 injection.
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 years at the time of signing the informed consent form, regardless of gender; 2. Confirmed as having ulcerative pyoderma gangrenosum (PG) with a PARACELSUS score of ≥10 points at screening; 3. At screening and baseline, having at least one measurable PG ulcer (defined as an ulcer with a measured area of ≥ 5 cm²); 4. 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; 5. Female participants of childbearing potential or male participants whose female partners are of childbearing potential have no plans for childbirth, sperm/egg donation from the time of signing the informed consent form, and voluntarily adopt highly effective contraceptive measures (including by the partner). Female participants must have a negative pregnancy test result during the screening period and before randomization and dosing, and must not be breastfeeding.
Exclusion criteria
1. Non-pyoderma gangrenosum (PG) diseases presenting with other ulcers or other similar skin lesions at screening; 2. The measured area of the target PG ulcer exceeding 80 cm² at screening; 3. Participants with chronic, non-inflammatory PG wounds or ulcers judged by the investigator to be unresponsive to immunosuppressive therapy at screening; 4. Participants with active infection in the PG ulcer(s) at screening; 5. A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases; 6. A history of any active malignant tumor or malignant neoplasm within 5 years prior to the screening visit, except for curatively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the uterine cervix; 7. Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | At any time before Week 26. | PGAR-100: 100% reduction in pyoderma gangrenosum (PG) ulcer area, i.e., complete ulcer closure. |
Secondary
| Measure | Time frame |
|---|---|
| The time to relapse in participants who achieved a complete response (complete closure of all PG ulcers) before Week 26. | Up to 64 weeks. |
| The time to the first achievement of PGAR-100 in the target PG ulcer before Week 26. | At any time before Week 26. |
| The time to the first achievement of PGAR-100 in any measurable PG ulcer before Week 26. | At any time before Week 26. |
| The time to the first achievement of PGAR-100 in all measurable PG ulcers before Week 26. | At any time before Week 26. |
Countries
China
Contacts
CONTACTXin Gao
CONTACTCaihong Huang
Outcome results
None listed