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

June 28, 2023 updated by: Aristea Therapeutics, Inc.

A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis

A 12-week Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis followed by an Open-label Extension Phase.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Québec, Canada, G1V 4X7
        • Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta Dermasurgery Centre
      • Edmonton, Alberta, Canada, T6H 4JB
        • VIDA Dermatology
      • Red Deer, Alberta, Canada, T4P 1K4
        • Central Alberta Research Clinic (CARe Clinic)
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc.
  • Czechia
      • Kutná Hora, Czechia, 284 01
        • Kozni ambulance Kutna Hora, s.r.o.
      • Prague, Czechia, 100 00
        • Clintrial S.R.O
      • Prague, Czechia, 150 00
        • Praglandia s.r.o.
  • Germany
      • Augsburg, Germany, 86156
        • Universitätsklinikum Augsburg Klinik für Dermatologie und Allergologie
      • Bad Bentheim, Germany, 48455
        • Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie
      • Dresden, Germany, 01307
        • Uniklinikum Dresden Klinik und Poliklinik für Dermatologie
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen Hautklinik
      • Hamburg, Germany, 20537
        • TFS Trial Form Support GmbH SCIderm - Zentrum für klinische Studien
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel [Zentrum für entzundliche Hauterkrankungen] Klinik für Dermatologie, Venerologie und Allergologie
      • Mahlow, Germany, 15831
        • Hautarztpraxis Mahlow
      • München, Germany, 80337
        • Klinikum der Universität München Klinik und Poliklinik der Dermatologie und Allergologie Der Universität München
      • Münster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Osnabrück, Germany, 49074
        • KliFOs - Klinische Forschung Osnabrück
      • Stuttgart, Germany, 70178
        • Hautarztpraxis Dres. Leitz & Kollegen
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis University, Department of Dermatology, Venerology and Dermatooncology
      • Debrecen, Hungary, 4012
        • University of Debrecen, Dermatology Department
      • Kecskemét, Hungary, 6000
        • Bács-Kiskun Megyei KórházSzegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza Bórgyógyászati Szakrendelés
      • Pécs, Hungary, 7632
        • University of Pecs, Department of Dermatology, Venerology and Oncodermatology
  • Poland
      • Kraków, Poland, 31-559
        • Diamond Clinic Spolka z ograniczona odpowiedzialnoscia
      • Lublin, Poland, 20-078
        • Clinical Best Solutions
      • Lublin, Poland, 20-573
        • Luxderm Specjalistyczny Gabinet Dermatologiczny
      • Warsaw, Poland, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, Poland, 01-142
        • Luxderm Specjalistyczny Gabinet Dermatologiczny
      • Wrocław, Poland, 51-318
        • dermMedica Sp. z o.o.
      • Wrocław, Poland, 50-566
        • Przychodnia Lekarsko-Psychologinczna Matusiak Spółka Partnerska
  • United Kingdom
      • Salford, United Kingdom, M6 8HD
        • Salford Care Organisation
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Total Skin & Beauty Dermatology Center, PC
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Dermatology Trial Associates
    • California
      • San Diego, California, United States, 92121
        • Cosmetic Laser Dermatology
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Driven Research LLC
      • Hollywood, Florida, United States, 33021
        • Encore Medical Research, Llc
      • North Miami Beach, Florida, United States, 33162
        • Tory Sullivan, MD PA
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Advanced Medical Research Pc
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • DS Research
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University School of Medicine-Dermatology
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC (Schlessinger MD)
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ALLCUTIS Research, LLC.
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Aventiv Research Inc.
      • Mayfield Heights, Ohio, United States, 44124
        • Apex Clinical Research Center
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Central Sooner Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • UPMC Department of Dermatology
    • Texas
      • San Antonio, Texas, United States, 78229
        • Dermatology Clinical Research Center of San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 6 months history of moderate or severe PPP, as defined by PPPASI ≥12 and PPPGA ≥3 at screening
  • Males and females must be willing to use birth control as indicated

Exclusion Criteria:

  • Moderate to severe psoriasis covering ≥10% of total body surface area (BSA) at screening
  • Breastfeeding or pregnant
  • Known immunodeficiency or subject is immunocompromised
  • Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB
  • Any topical medications for PPP excluding emollients within two weeks of randomization and systemic therapies (including phototherapy) within 4 weeks of randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RIST4721 400 mg
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
Drug: RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Experimental: RIST4721 200 mg
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
Drug: Placebo
Matching placebo
Drug: RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Placebo Comparator: Placebo
Placebo: 4 placebo tablets once daily for 12 weeks
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
Time Frame: 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).
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Absolute Change From Baseline in PPPGA
Time Frame: Baseline to Week 12
Baseline to Week 12
Absolute Change From Baseline in PPPASI
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristea Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RIST4721-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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