Palmoplantar Pustulosis of AdultsPhase 2NCT07923851
A Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis
A Phase 2 study testing SHR-1139 Injection in people with Palmoplantar Pustulosis of Adults, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR-1139 injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmoplantar Pustulosis of Adults
- What is being tested?
- SHR-1139 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2026to Mar 2029
- 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
- Participant is at least 18 years of age at the time of signing the ICF.
- BMI ≥18 kg/m² at screening.
- Confirmed diagnosis of PPP for at least 24 weeks prior to the screening visit.
- PPPASI ≥12 at both the screening visit and baseline visit.
- PPP-IGA ≥3 at both the screening visit and baseline visit.
- Participant has at least one palm and/or sole with moderate or severe pustules/vesicles at screening and baseline.
- Participant is a candidate for systemic therapy or phototherapy.
Who cannot join
- Participant has significant improvement in PPP symptoms from the screening visit to baseline visit, defined as a decrease in the PPPASI score.
- Participant has other skin diseases that would interfere with efficacy assessment.
- Drug-induced PPP.
- Participant is receiving or has previously received prohibited or restricted medications, with an interval prior to the baseline visit shorter than the required drug wash-out or stabilization period.
- Participant has a prior history of lymphoproliferative disorders.
- Concurrent other active autoimmune diseases.
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- Periodontitis requiring treatment at screening or baseline.
- Received infection-related tonsillectomy or dental treatment within 24 weeks prior to baseline.
- Chronic or recurrent tonsillitis or sinusitis at screening or baseline.
- Participants with any active malignancy or history of malignancy within 5 years prior to screening.
- Active tuberculosis (TB) or latent tuberculosis infection.
- 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.
- Women who are pregnant or breastfeeding.
- Allergy to any component of the investigational drug.
- History of alcohol abuse or illicit drug use within one year prior to screening.
- Receipt of live attenuated vaccine 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.
- Blood donation of approximately 500 mL within 8 weeks prior to randomization, or planned blood donation during the study period.
- Undergone major surgery within 8 weeks prior to screening, or planned surgery during the study period.
- Any other condition judged by the investigator that may affect the safety and efficacy evaluation of the investigational drug.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Bin Yang
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004
Songmei Geng
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis
The study is being conducted to evaluate the efficacy and safety of SHR-1139 injection.
- Conditions
- Palmoplantar Pustulosis of Adults
- Being tested
- SHR-1139 Injection, SHR-1139 Injection Placebo
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.
SHR-1139 Injection PlaceboDrug
SHR-1139 Injection Placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1139 Injection Group | Experimental | SHR-1139 Injection Receives: Drug: SHR-1139 Injection |
| SHR-1139 Injection Placebo Group | Placebo comparator | SHR-1139 Injection Placebo. Receives: Drug: SHR-1139 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI)
Absolute change from baseline in PPPASI score.
Measured: Baseline to Day 113.
Secondary outcomes (11)
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.
Measured: Baseline to Day 449.
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.
Measured: Baseline to Day 449.
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.
Measured: Baseline to Day 449.
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.
Measured: Baseline to Day 449.
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.
Measured: Baseline to Day 449.
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.
Measured: Baseline to Day 449.
Proportion of participants achieving PPPGA 0 by Day 449
Proportion of participants who achieve PPPGA 0 (clear).
Measured: Baseline to Day 449.
Change from baseline and percentage change from baseline in DLQI by Day 449
Absolute and percent change from baseline in DLQI.
Measured: Baseline to Day 449.
Safety and tolerability within 449 days: adverse events (AEs)
AEs assessed by vital signs, lab tests, and ECG.
Measured: Baseline to Day 449.
Pharmacokinetics (PK) within 449 days: serum concentration of SHR-1139
Serum concentration of SHR-1139 over time.
Measured: Baseline to Day 449.
Immunogenicity within 449 days: incidence and time of occurrence of positive anti-drug antibodies (ADA)
ADA incidence and onset time.
Measured: Baseline to Day 449.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmoplantar Pustulosis of AdultsStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1139 injection compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923851
- Sponsor's protocol ID
- SHR-1139-206
- Status last verified
- Nov 2026
- First submitted
- 30 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis
- ClinicalTrials.gov ID
- NCT07923851
- Acronym / sponsor ID
- SHR-1139-206
- Conditions
- Palmoplantar Pustulosis of Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 6 Nov 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.
The study is being conducted to evaluate the efficacy and safety of SHR-1139 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SHR-1139 injection compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| SHR-1139 Injection Group | Experimental | Drug: SHR-1139 InjectionSHR-1139 Injection |
| SHR-1139 Injection Placebo Group | Placebo comparator | Drug: SHR-1139 Injection PlaceboSHR-1139 Injection Placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is at least 18 years of age at the time of signing the ICF.
- BMI ≥18 kg/m² at screening.
- Confirmed diagnosis of PPP for at least 24 weeks prior to the screening visit.
- PPPASI ≥12 at both the screening visit and baseline visit.
- PPP-IGA ≥3 at both the screening visit and baseline visit.
Key exclusion criteria (19 listed)
- Participant has significant improvement in PPP symptoms from the screening visit to baseline visit, defined as a decrease in the PPPASI score.
- Participant has other skin diseases that would interfere with efficacy assessment.
- Drug-induced PPP.
- Participant is receiving or has previously received prohibited or restricted medications, with an interval prior to the baseline visit shorter than the required drug wash-out or stabilization period.
- Participant has a prior history of lymphoproliferative disorders.
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 |
| SHR-1139 Injection PlaceboSHR-1139 Injection Placebo. | Drug | SHR-1139 Injection Placebo Group |
Primary outcome
Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI)
Time frame: Baseline to Day 113.
Absolute change from baseline in PPPASI score.
11 secondary outcomes
Proportion of participants achieving at least 50% improvement from baseline in PPPASI (PPPASI 50) by Day 449
Time frame: Baseline to Day 449.
Proportion of participants achieving at least 75% improvement from baseline in PPPASI (PPPASI 75) by Day 449
Time frame: Baseline to Day 449.
Proportion of participants achieving Palmoplantar Pustulosis Physician's Global Assessment (PPPGA) score of 0 or 1 (PPPGA 0/1) by Day 449
Time frame: Baseline to Day 449.
Proportion of participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 by Day 449
Time frame: Baseline to Day 449.
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
Time frame: Baseline to Day 449.
Proportion of participants achieving PASI 75, PASI 90, and PASI 100 among those with baseline BSA ≥ 3%, within 449 days
Time frame: Baseline to Day 449.
Proportion of participants achieving PPPGA 0 by Day 449
Time frame: Baseline to Day 449.
Change from baseline and percentage change from baseline in DLQI by Day 449
Time frame: Baseline to Day 449.
Safety and tolerability within 449 days: adverse events (AEs)
Time frame: Baseline to Day 449.
Pharmacokinetics (PK) within 449 days: serum concentration of SHR-1139
Time frame: Baseline to Day 449.
Immunogenicity within 449 days: incidence and time of occurrence of positive anti-drug antibodies (ADA)
Time frame: Baseline to Day 449.
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 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites 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 Palmoplantar Pustulosis of Adults, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites 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 7 inclusion and 19 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Zeting Pan (86518-82342973, zeting.pan@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) (time frame: Baseline to Day 113.). 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 6 Nov 2026.