SHR-1139 Injection for Ulcerative Pyoderma Gangrenosum in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial evaluates the efficacy and safety of SHR-1139 Injection in adults with ulcerative pyoderma gangrenosum. Eligible participants have at least one measurable PG ulcer and require systemic therapy, and they will receive SHR-1139 as the study intervention. Outcomes focus on ulcer healing and safety signals over the treatment period. The study is conducted at a dermatology center affiliated with Shandong First Medical University. Lead sponsorship is provided by Shandong First Medical University with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).
* Diagnosed with ulcerative PG during screening, and requiring systemic treatment as assessed by the investigator.
* At screening and baseline, there is at least one measurable PG ulcer. If a subject has more than one PG ulcer, the investigator will select the target PG ulcer.
* Subjects voluntarily sign informed consent form (ICF) prior to the commencement of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical study protocol.
* Adequate organ and bone marrow function.
* Female subjects of childbearing potential or male subjects whose partners are females of childbearing potential shall have no plans for childbearing, sperm/egg donation from the time of signing the informed consent form until 72 weeks after the last dose, and shall voluntarily adopt effective contraceptive measures (including their partners). Female subjects must have a negative pregnancy test result during the screening period and before randomization and drug administration, and must not be breastfeeding.

Exclusion Criteria:

* At screening, the clinical manifestations are other ulcers or other similar skin lesions caused by non-PG diseases;
* There is a significant medical history or underlying disease that affects safety.
* A history of allergy to the study drug or any component of the study drug before screening.
* A history of alcohol abuse or illegal drug abuse within one year before screening;
* Having donated approximately 500 mL of blood within 8 weeks before baseline or having plans to donate blood during the study.
* Other circumstances that the investigator judges may affect the evaluation of the safety and efficacy of the study drug.

Where it's running

• Dermatology Hospital Affiliated to Shandong First Medical University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Furen Zhang
• Email: splcsy@126.com
• Phone: 15854179852

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Topical ruxolitinib for adults with pyoderma gangrenosum

  This pilot study tests a topical cream of ruxolitinib to see if it helps heal PG ulcers in adults without adding systemic immunosuppressants.

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• Evaluating biomarkers for coronary heart disease prognosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.