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RecruitingNCT07337564Updated Sep 9, 2026

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

A Phase 2 interventional study of SHR-1139 Injection in Pyoderma Gangrenosum, sponsored by Shandong First Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Shandong First Medical University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Pyoderma Gangrenosum

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03

In context

Pyoderma Gangrenosum

36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.

This study's planned enrollment of 10 is close to the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.

Browse Pyoderma Gangrenosum studies →

Lead sponsor

Shandong First Medical University is the lead sponsor of 9 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female, age ≥ 18 years old at the time of signing the 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 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 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

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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    SHR-1139 injection group

    Drug: SHR-1139 Injection

Interventions

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. adverse events(AEs)

    Time frame: up to Week 48

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07337564
Lead sponsor
Shandong First Medical University
Responsible party
Sponsor
First posted
Jan 13, 2026
Start date
Jan 29, 2026
Primary completion
Dec 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Furen Zhang
Contact
splcsy@126.com
15854179852

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: SHR-1139

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