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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Ulcerative Pyoderma Gangrenosum
- ClinicalTrials.gov ID
- NCT07337564
- Acronym / sponsor ID
- PG-IIT-SHR1139
- Conditions
- Pyoderma Gangrenosum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shandong First Medical UniversityUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to assess the therapeutic efficacy and safety of SHR-1139 Injection in adult patients with ulcerative pyoderma gangrenosum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1139 injection group | Experimental | Drug: SHR-1139 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1139 InjectionSHR-1139 Injection | Drug | SHR-1139 injection group |
Primary outcome
The proportion of subjects whose target PG ulcer achieves complete closure (100% reduction in PG area, PGAR-100) at Week 16.
Time frame: Week 16
3 secondary outcomes
The proportion of subjects whose target PG ulcer achieves 50% closure (50% reduction in PG area, PGAR-50) at Week 16
Time frame: 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;
Time frame: up to Week 26
adverse events(AEs)
Time frame: up to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1139 Injection in people with Pyoderma Gangrenosum, run by Shandong First Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Furen Zhang (15854179852, splcsy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects whose target PG ulcer achieves complete closure (100% reduction in PG area, PGAR-100) at Week 16. (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.