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Not yet recruitingNCT07444684Updated Mar 3, 2026

A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum

A Phase 2 interventional study of SHR-1139 Injection in Pyoderma Gangrenosum, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with 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 20 is above the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.

Browse Pyoderma Gangrenosum studies →

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 59 studies on the registry; 25 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

  1. Aged ≥18 years at the time of signing the form, regardless of gender;
  2. Confirmed as having ulcerative pyoderma gangrenosum (PG) with a PARACELSUS score of ≥10 points at screening;
  3. At screening and baseline, having at least one measurable PG ulcer (defined as an ulcer with a measured area of ≥ 5 cm²);
  4. The participant voluntarily signs the informed consent form before the initiation of any study-related procedures, is able to communicate smoothly with the investigator, and understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
  5. Female participants of or male participants whose female partners are of childbearing potential have no plans for childbirth, sperm/egg donation from the time of signing the informed consent form, and voluntarily adopt highly effective measures (including by the partner). Female participants must have a negative pregnancy test result during the screening period and before randomization and dosing, and must not be breastfeeding.

Exclusion criteria

Exclusion Criteria:

  1. Non-pyoderma gangrenosum (PG) diseases presenting with other ulcers or other similar skin lesions at screening;
  2. The measured area of the target PG ulcer exceeding 80 cm² at screening;
  3. Participants with chronic, non-inflammatory PG wounds or ulcers judged by the investigator to be unresponsive to therapy at screening;
  4. Participants with active infection in the PG ulcer(s) at screening;
  5. A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases;
  6. A history of any active malignant tumor or malignant neoplasm within 5 years prior to the screening visit, except for curatively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the uterine cervix;
  7. Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.
Terms in these criteria, in plain language(4)

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

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

Study arms

  • Experimental
    SHR-1139 Injection Group

    Drug: SHR-1139 Injection

Interventions

06

What researchers measure

Primary outcomes

  1. The proportion of participants who achieved PGAR-100 in the target PG ulcer at any time before Week 26, with confirmation at the next consecutive study visit (at least 2 weeks later).

    PGAR-100: 100% reduction in pyoderma gangrenosum (PG) ulcer area, i.e., complete ulcer closure.

    Time frame: At any time before Week 26.

Secondary outcomes

  1. The time to relapse in participants who achieved a complete response (complete closure of all PG ulcers) before Week 26.

    Time frame: Up to 64 weeks.

  2. The time to the first achievement of PGAR-100 in the target PG ulcer before Week 26.

    Time frame: At any time before Week 26.

  3. The time to the first achievement of PGAR-100 in any measurable PG ulcer before Week 26.

    Time frame: At any time before Week 26.

  4. The time to the first achievement of PGAR-100 in all measurable PG ulcers before Week 26.

    Time frame: At any time before Week 26.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

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 Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07444684
Responsible party
Sponsor
First posted
Mar 3, 2026
Start date
Mar 5, 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Apr 2028 (estimated)
Last update
Mar 3, 2026

Study contacts

Xin Gao
Contact
xin.gao.xg26@hengrui.com
+86-0518-82342973
Caihong Huang
Contact
caihong.huang.ch57@hengrui.com
+86-0518-82342973

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: SHR-1139

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