A Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis
NCT07923851, Phase 2, Not yet recruiting, Guangdong Hengrui Pharmaceutical Co., Ltd
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis | ClinicalTrials.gov |
| NCT number | NCT07923851 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd | ClinicalTrials.gov |
| Conditions | Palmoplantar Pustulosis of Adults | ClinicalTrials.gov |
| Interventions | SHR-1139 Injection, SHR-1139 Injection Placebo | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) | Baseline to Day 113. | Absolute change from baseline in PPPASI score. | ClinicalTrials.gov |
| Secondary | Proportion of participants achieving at least 50% improvement from baseline in PPPASI (PPPASI 50) by Day 449 | Baseline to Day 449. | Proportion of participants who achieve PPPASI 50 response. | ClinicalTrials.gov |
| Secondary | Proportion of participants achieving at least 75% improvement from baseline in PPPASI (PPPASI 75) by Day 449 | Baseline to Day 449. | Proportion of participants who achieve PPPASI 75 response. | ClinicalTrials.gov |
| Secondary | Proportion of participants achieving Palmoplantar Pustulosis Physician's Global Assessment (PPPGA) score of 0 or 1 (PPPGA 0/1) by Day 449 | Baseline to Day 449. | Proportion of participants who achieve PPPGA 0/1 response. | ClinicalTrials.gov |
| Secondary | Proportion of participants achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 by Day 449 | Baseline to Day 449. | Proportion of participants who achieve DLQI 0/1 response. | ClinicalTrials.gov |
| Secondary | 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 | Baseline to Day 449. | Absolute and percent change from baseline in PASI. | ClinicalTrials.gov |
| Secondary | Proportion of participants achieving PASI 75, PASI 90, and PASI 100 among those with baseline BSA ≥ 3%, within 449 days | Baseline to Day 449. | Proportion of participants who achieve PASI 75/90/100 response. | ClinicalTrials.gov |
| Secondary | Proportion of participants achieving PPPGA 0 by Day 449 | Baseline to Day 449. | Proportion of participants who achieve PPPGA 0 (clear). | ClinicalTrials.gov |
| Secondary | Change from baseline and percentage change from baseline in DLQI by Day 449 | Baseline to Day 449. | Absolute and percent change from baseline in DLQI. | ClinicalTrials.gov |
| Secondary | Safety and tolerability within 449 days: adverse events (AEs) | Baseline to Day 449. | AEs assessed by vital signs, lab tests, and ECG. | ClinicalTrials.gov |
| Secondary | Pharmacokinetics (PK) within 449 days: serum concentration of SHR-1139 | Baseline to Day 449. | Serum concentration of SHR-1139 over time. | ClinicalTrials.gov |
| Secondary | Immunogenicity within 449 days: incidence and time of occurrence of positive anti-drug antibodies (ADA) | Baseline to Day 449. | ADA incidence and onset time. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)