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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 74 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05194839
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aristea Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Czechia, Germany, Hungary, Poland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Palmoplantar Pustulosis
Arms & Interventions

Arms

Experimental: RIST4721 400 mg

RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks

Experimental: RIST4721 200 mg

RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks

Placebo Comparator: Placebo

Placebo: 4 placebo tablets once daily for 12 weeks

Interventions

Drug: - RIST4721

RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets

Drug: - Placebo

Matching placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Recruiting

Address

Total Skin & Beauty Dermatology Center, PC

Birmingham, Alabama, 35205

Dermatology Trial Associates, Bryant, Arkansas

Status

Recruiting

Address

Dermatology Trial Associates

Bryant, Arkansas, 72022

Cosmetic Laser Dermatology, San Diego, California

Status

Recruiting

Address

Cosmetic Laser Dermatology

San Diego, California, 92121

Clinical Science Institute, Santa Monica, California

Status

Recruiting

Address

Clinical Science Institute

Santa Monica, California, 90404

Driven Research LLC, Coral Gables, Florida

Status

Recruiting

Address

Driven Research LLC

Coral Gables, Florida, 33134

Encore Medical Research, LLC, Hollywood, Florida

Status

Recruiting

Address

Encore Medical Research, LLC

Hollywood, Florida, 33021

Tory Sullivan, MD PA, North Miami Beach, Florida

Status

Recruiting

Address

Tory Sullivan, MD PA

North Miami Beach, Florida, 33162

Advanced Medical Research PC, Sandy Springs, Georgia

Status

Recruiting

Address

Advanced Medical Research PC

Sandy Springs, Georgia, 30328

Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

DS Research, Louisville, Kentucky

Status

Recruiting

Address

DS Research

Louisville, Kentucky, 40241

Great Lakes Research Group, Inc., Bay City, Michigan

Status

Recruiting

Address

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706

Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine-Dermatology

Saint Louis, Missouri, 63108

Skin Specialists, PC (Schlessinger MD), Omaha, Nebraska

Status

Recruiting

Address

Skin Specialists, PC (Schlessinger MD)

Omaha, Nebraska, 68144

ALLCUTIS Research, LLC., Portsmouth, New Hampshire

Status

Recruiting

Address

ALLCUTIS Research, LLC.

Portsmouth, New Hampshire, 03801

Aventiv Research Inc., Dublin, Ohio

Status

Recruiting

Address

Aventiv Research Inc.

Dublin, Ohio, 43016

Apex Clinical Research Center, Mayfield Heights, Ohio

Status

Recruiting

Address

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124

Central Sooner Research, Norman, Oklahoma

Status

Recruiting

Address

Central Sooner Research

Norman, Oklahoma, 73071

UPMC Department of Dermatology, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15212

San Antonio, Texas

Status

Recruiting

Address

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229

International Sites

Alberta DermaSurgery Centre, Edmonton, Alberta, Canada

Status

Recruiting

Address

Alberta DermaSurgery Centre

Edmonton, Alberta, T6G 1C3

Vida Dermatology, Edmonton, Alberta, Canada

Status

Recruiting

Address

Vida Dermatology

Edmonton, Alberta, T6H 4JB

Red Deer, Alberta, Canada

Status

Recruiting

Address

Central Alberta Research Clinic (CARe Clinic)

Red Deer, Alberta, T4P 1K4

SimcoDerm Medical and Surgical, Barrie, Ontario, Canada

Status

Recruiting

Address

SimcoDerm Medical and Surgical

Barrie, Ontario, L4M 7G1

Lynderm Research Inc., Markham, Ontario, Canada

Status

Recruiting

Address

Lynderm Research Inc.

Markham, Ontario, L3P 1X3

Québec, Canada

Status

Recruiting

Address

Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.

Québec, , G1V 4X7

Kožní ambulance Kutná Hora, s.r.o., Kutná Hora, Czechia

Status

Recruiting

Address

Kožní ambulance Kutná Hora, s.r.o.

Kutná Hora, , 284 01

Clintrial s.r.o, Prague, Czechia

Status

Recruiting

Address

Clintrial s.r.o

Prague, , 100 00

Praglandia s.r.o., Prague, Czechia

Status

Recruiting

Address

Praglandia s.r.o.

Prague, , 150 00

Augsburg, Germany

Status

Recruiting

Address

Universitätsklinikum Augsburg Klinik für Dermatologie und Allergologie

Augsburg, , 86156

Bad Bentheim, Germany

Status

Recruiting

Address

Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie

Bad Bentheim, , 48455

Dresden, Germany

Status

Recruiting

Address

Uniklinikum Dresden Klinik und Poliklinik für Dermatologie

Dresden, , 01307

Universitätsklinikum Erlangen Hautklinik, Erlangen, Germany

Status

Recruiting

Address

Universitätsklinikum Erlangen Hautklinik

Erlangen, , 91054

Hamburg, Germany

Status

Recruiting

Address

TFS Trial Form Support GmbH SCIderm - Zentrum für klinische Studien

Hamburg, , 20537

Kiel, Germany

Status

Recruiting

Address

Universitätsklinikum Schleswig-Holstein, Campus Kiel [Zentrum für entzundliche Hauterkrankungen] Klinik für Dermatologie, Venerologie und Allergologie

Kiel, , 24105

Hautarztpraxis Mahlow, Mahlow, Germany

Status

Recruiting

Address

Hautarztpraxis Mahlow

Mahlow, , 15831

München, Germany

Status

Recruiting

Address

Klinikum der Universität München Klinik und Poliklinik der Dermatologie und Allergologie Der Universität München

München, , 80337

Universitaetsklinikum Muenster, Münster, Germany

Status

Recruiting

Address

Universitaetsklinikum Muenster

Münster, , 48149

KliFOs - Klinische Forschung Osnabrück, Osnabrück, Germany

Status

Recruiting

Address

KliFOs - Klinische Forschung Osnabrück

Osnabrück, , 49074

Hautarztpraxis Dres. Leitz & Kollegen, Stuttgart, Germany

Status

Recruiting

Address

Hautarztpraxis Dres. Leitz & Kollegen

Stuttgart, , 70178

Budapest, Hungary

Status

Recruiting

Address

Semmelweis University, Department of Dermatology, Venerology and Dermatooncology

Budapest, , 1085

Debrecen, Hungary

Status

Recruiting

Address

University of Debrecen, Dermatology Department

Debrecen, , 4012

Kecskemét, Hungary

Status

Recruiting

Address

Bács-Kiskun Megyei KórházSzegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza Bórgyógyászati Szakrendelés

Kecskemét, , 6000

Pécs, Hungary

Status

Recruiting

Address

University of Pecs, Department of Dermatology, Venerology and Oncodermatology

Pécs, , 7632

Kraków, Poland

Status

Recruiting

Address

Diamond Clinic Spolka z ograniczona odpowiedzialnoscia

Kraków, , 31-559

Clinical Best Solutions, Lublin, Poland

Status

Recruiting

Address

Clinical Best Solutions

Lublin, , 20-078

Lublin, Poland

Status

Recruiting

Address

Luxderm Specjalistyczny Gabinet Dermatologiczny

Lublin, , 20-573

Warsaw, Poland

Status

Recruiting

Address

Luxderm Specjalistyczny Gabinet Dermatologiczny

Warsaw, , 01-142

Royalderm Agnieszka Nawrocka, Warsaw, Poland

Status

Recruiting

Address

Royalderm Agnieszka Nawrocka

Warsaw, , 02-962

Wrocław, Poland

Status

Recruiting

Address

Przychodnia Lekarsko-Psychologinczna Matusiak Spółka Partnerska

Wrocław, , 50-566

DermMedica Sp. z o.o., Wrocław, Poland

Status

Recruiting

Address

DermMedica Sp. z o.o.

Wrocław, , 51-318

Salford Care Organisation, Salford, United Kingdom

Status

Recruiting

Address

Salford Care Organisation

Salford, , M6 8HD

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