Pyoderma GangrenosumPhase 2NCT07337564
A Clinical Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Ulcerative Pyoderma Gangrenosum
A Phase 2 study testing SHR-1139 Injection in people with Pyoderma Gangrenosum, run by Shandong First Medical University at 1 site in China.
Trial summary
This study was designed to assess the therapeutic efficacy and safety of SHR-1139 Injection in adult patients with ulcerative pyoderma gangrenosum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- SHR-1139 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2026to Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dermatology Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000
Furen Zhang, 15854179852, splcsy@126.com
About this study
This study was designed to assess the therapeutic efficacy and safety of SHR-1139 Injection in adult patients with ulcerative pyoderma gangrenosum.
- Conditions
- Pyoderma Gangrenosum
- Being tested
- SHR-1139 Injection
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1139 InjectionDrug
SHR-1139 Injection
| Study group | Role | What they receive |
|---|---|---|
| SHR-1139 injection group | Experimental | Not described Receives: Drug: SHR-1139 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects whose target PG ulcer achieves complete closure (100% reduction in PG area, PGAR-100) at Week 16.
Measured: Week 16
Secondary outcomes (3)
The proportion of subjects whose target PG ulcer achieves 50% closure (50% reduction in PG area, PGAR-50) at Week 16
Measured: Week 16
The proportion of subjects whose target PG ulcer achieves complete closure (100% reduction in PG area, PGAR-100) at any time point before Week 26;
Measured: up to Week 26
adverse events(AEs)
Measured: up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start29 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong First Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337564
- Sponsor's protocol ID
- PG-IIT-SHR1139
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No