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This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1139 Injection Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1139 Injection | Drug | SHR-1139 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At any time before Week 26. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Gao | Contact | +86-0518-82342973 | xin.gao.xg26@hengrui.com | |
| Caihong Huang | Contact | +86-0518-82342973 | caihong.huang.ch57@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong First Medical University Affiliated Dermatology Hospital | Jinan | Shandong | 250022 | China |
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| ID | Term |
|---|---|
| D017511 | Pyoderma Gangrenosum |
| ID | Term |
|---|---|
| D011711 | Pyoderma |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
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| 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. |
| D012883 |
| Skin Ulcer |