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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Achieving a 50% Reduction in PPPASI Score | Baseline 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). |
| Secondary | Absolute Change From Baseline in PPPGA | Baseline to Week 12 | |
| Secondary | Absolute Change From Baseline in PPPASI | Baseline to Week 12 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Achieving a 50% Reduction in PPPASI Score | Baseline to Week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Absolute Change From Baseline in PPPGA | Baseline to Week 12 | |||
| SECONDARY | Absolute Change From Baseline in PPPASI | Baseline to Week 12 |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Achieving a 50% Reduction in PPPASI Score | RIST4721 400 mg | 6 | Participants | ||
| Proportion of Subjects Achieving a 50% Reduction in PPPASI Score | RIST4721 200 mg | 3 | Participants | ||
| Proportion of Subjects Achieving a 50% Reduction in PPPASI Score | Placebo | 5 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RIST4721 400 mg | 27 | |
| Overall Study | STARTED | RIST4721 200 mg | 26 | |
| Overall Study | STARTED | Placebo | 26 | |
| Overall Study | COMPLETED | RIST4721 400 mg | 12 | |
| Overall Study | COMPLETED | RIST4721 200 mg | 13 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | RIST4721 400 mg | 15 | |
| Overall Study | NOT COMPLETED | RIST4721 200 mg | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events204
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 |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | RIST4721 400 mg | 1 | 27 | |
| other | Nasopharyngitis | Infections and infestations | RIST4721 200 mg | 3 | 26 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 4 | 26 | |
| other | Urinary Tract Infection | Infections and infestations | RIST4721 400 mg | 1 | 27 | |
| other | Urinary Tract Infection | Infections and infestations | RIST4721 200 mg | 1 | 26 | |
| other | Urinary Tract Infection | Infections and infestations | Placebo | 1 | 26 | |
| other | Covid-19 | Infections and infestations | RIST4721 400 mg | 1 | 27 | |
| other | Covid-19 | Infections and infestations | RIST4721 200 mg | 0 | 26 | |
| other | Covid-19 | Infections and infestations | Placebo | 1 | 26 | |
| other | Upper respiratory tract infection | Infections and infestations | RIST4721 400 mg | 1 | 27 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RIST4721 400 mg | 0 | 27 |
| Total, all-cause mortality | RIST4721 200 mg | 0 | 26 |
| Total, all-cause mortality | Placebo | 0 | 26 |
| Total, other adverse events | RIST4721 400 mg | 18 | 27 |
| Total, other adverse events | RIST4721 200 mg | 17 | 26 |
| Total, other adverse events | Placebo | 18 | 26 |
| Total, serious adverse events | RIST4721 400 mg | 0 | 27 |
| Total, serious adverse events | RIST4721 200 mg | 1 | 26 |
| Total, serious adverse events | Placebo | 0 | 26 |
Source ClinicalTrials.gov
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.
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