NCT07337564 A Clinical Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Ulcerative Pyoderma Gangrenosum
| NCT ID | NCT07337564 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shandong First Medical University |
| Condition | Pyoderma Gangrenosum |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-01-29 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2026-01-29 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study was designed to assess the therapeutic efficacy and safety of SHR-1139 Injection in adult patients with ulcerative pyoderma gangrenosum.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07337564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pyoderma Gangrenosum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07337564 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07337564 currently recruiting?
Yes, NCT07337564 is actively recruiting participants. Contact the research team at splcsy@126.com for enrollment information.
Where is the NCT07337564 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07337564 clinical trial?
NCT07337564 is sponsored by Shandong First Medical University. The trial plans to enroll 10 participants.