ClinicalTrials.gg
Not yet recruitingNCT07923851Updated Nov 6, 2026

A Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis

A Phase 2 interventional study of SHR-1139 Injection and SHR-1139 Injection Placebo in Palmoplantar Pustulosis of Adults, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

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

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study is being conducted to evaluate the efficacy and safety of SHR-1139 injection.

02

Conditions studied

  • Palmoplantar Pustulosis of Adults
03

In context

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. Participant is at least 18 years of age at the time of signing the ICF.
  2. ≥18 kg/m² at screening.
  3. Confirmed diagnosis of PPP for at least 24 weeks prior to the screening visit.
  4. PPPASI ≥12 at both the screening visit and baseline visit.
  5. PPP-IGA ≥3 at both the screening visit and baseline visit.
  6. Participant has at least one palm and/or sole with moderate or severe pustules/vesicles at screening and baseline.
  7. Participant is a candidate for systemic therapy or phototherapy.

Exclusion criteria

Exclusion Criteria:

  1. Participant has significant improvement in PPP symptoms from the screening visit to baseline visit, defined as a decrease in the PPPASI score.
  2. Participant has other skin diseases that would interfere with efficacy assessment.
  3. Drug-induced PPP.
  4. Participant is receiving or has previously received prohibited or restricted medications, with an interval prior to the baseline visit shorter than the required drug or stabilization period.
  5. Participant has a prior history of lymphoproliferative disorders.
  6. Concurrent other active diseases.
  7. Periodontitis requiring treatment at screening or baseline.
  8. Received infection-related tonsillectomy or dental treatment within 24 weeks prior to baseline.
  9. Chronic or recurrent tonsillitis or sinusitis at screening or baseline.
  10. Participants with any active or history of malignancy within 5 years prior to screening.
  11. Active tuberculosis (TB) or latent tuberculosis infection.
  12. Severe, progressive, or uncontrolled cardiovascular, cerebrovascular, hepatic, renal, pulmonary, gastrointestinal, hematopoietic, endocrine, neurological, psychiatric (e.g., depression, suicidal tendencies, and psychological disorders), skin or mucosal diseases, or any other condition that the investigator considers inappropriate for participation in this study.
  13. Women who are pregnant or breastfeeding.
  14. Allergy to any component of the drug.
  15. History of alcohol abuse or illicit drug use within one year prior to screening.
  16. Receipt of or live vaccine within 12 weeks prior to randomization, or planned receipt of such vaccines during the study period, or participation in a vaccine clinical trial within 12 weeks prior to randomization.
  17. Blood donation of approximately 500 mL within 8 weeks prior to randomization, or planned blood donation during the study period.
  18. Undergone major surgery within 8 weeks prior to screening, or planned surgery during the study period.
  19. Any other condition judged by the investigator that may affect the safety and efficacy evaluation of the investigational drug.
Terms in these criteria, in plain language(6)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    SHR-1139 Injection Group

    SHR-1139 Injection

    Drug: SHR-1139 Injection

  • Placebo comparator
    SHR-1139 Injection Placebo Group

    SHR-1139 Injection Placebo.

    Drug: SHR-1139 Injection Placebo

Interventions

  • SHR-1139 Injection.

  • DrugSHR-1139 Injection Placebo

    SHR-1139 Injection Placebo.

06

What researchers measure

Primary outcomes

  1. Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI)

    Absolute change from baseline in PPPASI score.

    Time frame: Baseline to Day 113.

Secondary outcomes

  1. Proportion of participants achieving at least 50% improvement from baseline in PPPASI (PPPASI 50) by Day 449

    Proportion of participants who achieve PPPASI 50 response.

    Time frame: Baseline to Day 449.

  2. Proportion of participants achieving at least 75% improvement from baseline in PPPASI (PPPASI 75) by Day 449

    Proportion of participants who achieve PPPASI 75 response.

    Time frame: Baseline to Day 449.

  3. Proportion of participants achieving Palmoplantar Pustulosis Physician's Global Assessment (PPPGA) score of 0 or 1 (PPPGA 0/1) by Day 449

    Proportion of participants who achieve PPPGA 0/1 response.

    Time frame: Baseline to Day 449.

  4. Proportion of participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 by Day 449

    Proportion of participants who achieve DLQI 0/1 response.

    Time frame: Baseline to Day 449.

  5. Change from baseline and percentage change from baseline in Psoriasis Area and Severity Index (PASI) score among participants with baseline BSA ≥ 3%, within 449 days

    Absolute and percent change from baseline in PASI.

    Time frame: Baseline to Day 449.

  6. Proportion of participants achieving PASI 75, PASI 90, and PASI 100 among those with baseline BSA ≥ 3%, within 449 days

    Proportion of participants who achieve PASI 75/90/100 response.

    Time frame: Baseline to Day 449.

  7. Proportion of participants achieving PPPGA 0 by Day 449

    Proportion of participants who achieve PPPGA 0 (clear).

    Time frame: Baseline to Day 449.

  8. Change from baseline and percentage change from baseline in DLQI by Day 449

    Absolute and percent change from baseline in DLQI.

    Time frame: Baseline to Day 449.

  9. Safety and tolerability within 449 days: adverse events (AEs)

    AEs assessed by vital signs, lab tests, and ECG.

    Time frame: Baseline to Day 449.

  10. Pharmacokinetics (PK) within 449 days: serum concentration of SHR-1139

    Serum concentration of SHR-1139 over time.

    Time frame: Baseline to Day 449.

  11. Immunogenicity within 449 days: incidence and time of occurrence of positive anti-drug antibodies (ADA)

    ADA incidence and onset time.

    Time frame: Baseline to Day 449.

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07923851
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Mar 2029 (estimated)
Last update
Nov 6, 2026

Study contacts

Zeting Pan
Contact
zeting.pan@hengrui.com
86518-82342973
Caihong Huang
Contact
caihong.huang.ch57@hengrui.com
86518-82342973

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 Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: SHR-1139

Start the discussion