A Clinical Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Ulcerative Pyoderma Gangrenosum

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong First Medical University

About this trial

This study was designed to assess the therapeutic efficacy and safety of SHR-1139 Injection in adult patients with ulcerative pyoderma gangrenosum.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SHR-1139 Injection

Treatment groups

10 Participants
are divided into 1 treatment group