A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum

Official title

A Phase II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 Injection in Adult Patients With Pyoderma Gangrenosum

Overview

This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.

Interventions

• Drug SHR-1139 Injection
  SHR-1139 injection.

Primary outcome measures

• 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). [Time frame: At any time before Week 26.]

Secondary outcome measures (4)

• 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.]

Eligibility criteria

Inclusion criteria

• 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;
• 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

• 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;
• A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases;
• 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;
• Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shandong First Medical University Affiliated Dermatology Hospital — Jinan

Identifiers

NCT: NCT07444684 · SHR-1139-203

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗