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Trial · NCT05194839

A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

NCT05194839, Phase 2, Terminated, Aristea Therapeutics, Inc.; results first posted 2023-06-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP). Trials, record NCT05194839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05194839

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
NCT number
NCT05194839
Status
Terminated
Phases
Phase 2
Enrollment
79 participants, actual
Lead sponsor
Aristea Therapeutics, Inc.
Conditions
Palmoplantar Pustulosis
Interventions
RIST4721, Placebo
First posted
2022-01-18
Last updated
2023-06-29
Results first posted
2023-06-29

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProportion of Subjects Achieving a 50% Reduction in PPPASI ScoreBaseline to Week 12
In the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), the left palm, right palm, left foot, and right foot are assessed based on 3 target symptoms: erythema, desquamation (scaling), and pustules, as seen on the day of the examination. The severity of each sign is assessed using a 5-point scale (0 = not present, 1 = slight, 3 = moderate, 4 = severe, 5 = very severe). The affected area within a given anatomic site (left palm, right palm, left foot, and right foot) is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of PPP involvement (0 = no involvement, 2 = 10 to less than 30% involvement, 3 = 30 to less than 50% involvement, 4 = 50 to less than 70% involvement, 5 = 70 to less than 90% involvement, 6 = 90 to less than 100% involvement). PPPASI score for palms and soles is obtained using a formula and can vary from 0 (absence of disease) to 72 (most severe disease).
SecondaryAbsolute Change From Baseline in PPPGABaseline to Week 12
SecondaryAbsolute Change From Baseline in PPPASIBaseline to Week 12

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProportion of Subjects Achieving a 50% Reduction in PPPASI ScoreBaseline to Week 12ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAbsolute Change From Baseline in PPPGABaseline to Week 12
SECONDARYAbsolute Change From Baseline in PPPASIBaseline to Week 12

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Proportion of Subjects Achieving a 50% Reduction in PPPASI ScoreRIST4721 400 mg6Participants
Proportion of Subjects Achieving a 50% Reduction in PPPASI ScoreRIST4721 200 mg3Participants
Proportion of Subjects Achieving a 50% Reduction in PPPASI ScorePlacebo5Participants

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDRIST4721 400 mg27
Overall StudySTARTEDRIST4721 200 mg26
Overall StudySTARTEDPlacebo26
Overall StudyCOMPLETEDRIST4721 400 mg12
Overall StudyCOMPLETEDRIST4721 200 mg13
Overall StudyCOMPLETEDPlacebo12
Overall StudyNOT COMPLETEDRIST4721 400 mg15
Overall StudyNOT COMPLETEDRIST4721 200 mg13
Overall StudyNOT COMPLETEDPlacebo14

Adverse events204

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherNasopharyngitisInfections and infestationsRIST4721 400 mg127
otherNasopharyngitisInfections and infestationsRIST4721 200 mg326
otherNasopharyngitisInfections and infestationsPlacebo426
otherUrinary Tract InfectionInfections and infestationsRIST4721 400 mg127
otherUrinary Tract InfectionInfections and infestationsRIST4721 200 mg126
otherUrinary Tract InfectionInfections and infestationsPlacebo126
otherCovid-19Infections and infestationsRIST4721 400 mg127
otherCovid-19Infections and infestationsRIST4721 200 mg026
otherCovid-19Infections and infestationsPlacebo126
otherUpper respiratory tract infectionInfections and infestationsRIST4721 400 mg127

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityRIST4721 400 mg027
Total, all-cause mortalityRIST4721 200 mg026
Total, all-cause mortalityPlacebo026
Total, other adverse eventsRIST4721 400 mg1827
Total, other adverse eventsRIST4721 200 mg1726
Total, other adverse eventsPlacebo1826
Total, serious adverse eventsRIST4721 400 mg027
Total, serious adverse eventsRIST4721 200 mg126
Total, serious adverse eventsPlacebo026

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT05194839

GET https://conductscience.org/api/trials/v1/NCT05194839/events?page=2