Trial · NCT04061252
A Study of KHK4827 in Subjects With Palmoplantar Pustulosis
NCT04061252, Phase 3, Completed, Kyowa Kirin Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of KHK4827 in Subjects With Palmoplantar Pustulosis. Trials, record NCT04061252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04061252
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of KHK4827 in Subjects With Palmoplantar Pustulosis
- NCT number
- NCT04061252
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 126 participants, actual
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Conditions
- Palmoplantar Pustulosis
- Interventions
- KHK4827, Placebo
- First posted
- 2019-08-19
- Last updated
- 2023-02-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16 | Baseline, Week 16 | PPPASI is composed of subscores of erythema (E), pustules/vesicles (P), desquamation/scales (D) on the left (L) and right (R) palm (P) and sole (S) respectively. PPPASI is calculated by the following calculation formula. PPPASI=(E+P+D) Area\*0.2 (RP)+(E+P+D) Area\*0.2 (LP)+ (E+P+D) Area\*0.3 (RS)+(E+P+D) Area\*0.3 (LS). |
| Secondary | Change from baseline in Palmoplantar Pustulosis Severity Index (PPP-SI) total score at Week 16 | Baseline, Week 16 | (PPP-SI) total score at Week 16. PPP-SI assesses the severity of palmoplantar pustulosis skin lesions and response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity. |
| Secondary | The percentage of participants who achieved at least 50% improvement in PPPASI score from Baseline to Week 16 | Week 16 | |
| Secondary | The percentage of participants who achieved at least 75% improvement in PPPASI score from Baseline to Week 16 | Week 16 | |
| Secondary | The percentage of participants who achieved a Physician's Global Assessment(PGA) score of 0 or 1 at Week 16 | Week 16 | |
| Secondary | Change from baseline in PPPASI total score at each assessment time point | Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 | |
| Secondary | Change from baseline in PPP-SI total score at each assessment time point | Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 | |
| Secondary | Change from baseline in Dermatology Life Quality Index (DLQI) score at each evaluation point | Baseline, Week 8, 16, 24, 32, 44, 56, 68 | The DLQI is a skin disease-specific scale that assesses the impact of skin symptoms on QOL during the past 7 days and consists of 10 questions relating to "symptoms and feelings", "daily activities", "leisure", "work and employment", "personal relationship", and "treatment". The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04061252
GET https://conductscience.org/api/trials/v1/NCT04061252/registered