New injection aims to heal skin ulcers in rare disease
NCT ID NCT07337564
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This phase 2 trial tests an injection called SHR-1139 in 10 adults with ulcerative pyoderma gangrenosum, a rare skin condition that causes painful, open sores. The main goal is to see if the drug can completely close the target ulcer within 12 weeks. Researchers will also check for side effects and partial healing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-1139 injection
- What this could lead to
- If it works, this could point toward a new treatment option for pyoderma gangrenosum, helping ulcers heal faster.
- What could go wrong
- This is a very small early-phase trial with only 10 people, so results may not apply broadly. The drug may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dermatology Hospital Affiliated to Shandong First Medical University
RECRUITINGJinan, Shandong, 250000, China
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