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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Palmoplantar Pustulosis of Adults
• Intervention / Treatment: Drug: SHR-1139 Injection; Drug: SHR-1139 Injection Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zeting Pan; Phone Number: 86518-82342973; Email: zeting.pan@hengrui.com
• Study Contact Backup: Name: Caihong Huang; Phone Number: 86518-82342973; Email: caihong.huang.ch57@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University
      • Principal Investigator: Bin Yang
  • Shanxi
    • Xi’an, Shanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Principal Investigator: Songmei Geng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participant is at least 18 years of age at the time of signing the ICF.
2. BMI ≥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:

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 wash-out or stabilization period.
5. Participant has a prior history of lymphoproliferative disorders.
6. Concurrent other active autoimmune 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 malignancy 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 investigational drug.
15. History of alcohol abuse or illicit drug use within one year prior to screening.
16. 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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1139 Injection Group; SHR-1139 Injection	Drug: SHR-1139 Injection; SHR-1139 Injection.
Placebo Comparator: SHR-1139 Injection Placebo Group; SHR-1139 Injection Placebo.	Drug: SHR-1139 Injection Placebo; SHR-1139 Injection Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI)	Absolute change from baseline in PPPASI score.	Baseline to Day 113.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline to Day 449.
Proportion of participants achieving PPPGA 0 by Day 449	Proportion of participants who achieve PPPGA 0 (clear).	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.	Baseline to Day 449.
Safety and tolerability within 449 days: adverse events (AEs)	AEs assessed by vital signs, lab tests, and ECG.	Baseline to Day 449.
Pharmacokinetics (PK) within 449 days: serum concentration of SHR-1139	Serum concentration of SHR-1139 over time.	Baseline to Day 449.
Immunogenicity within 449 days: incidence and time of occurrence of positive anti-drug antibodies (ADA)	ADA incidence and onset time.	Baseline to Day 449.

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: October 30, 2026
• First Submitted That Met QC Criteria: November 3, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 3, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1139-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No