A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
NCT ID: NCT05194839
Last Updated: 2023-06-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
79 participants
INTERVENTIONAL
2022-01-05
2023-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RIST4721 400 mg
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
RIST4721 200 mg
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Placebo
Matching placebo
Placebo
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo
Matching placebo
Interventions
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RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* Males and females must be willing to use birth control as indicated
Exclusion Criteria
* 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
18 Years
74 Years
ALL
No
Sponsors
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Aristea Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Dermatology Trial Associates
Bryant, Arkansas, United States
Cosmetic Laser Dermatology
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Driven Research LLC
Coral Gables, Florida, United States
Encore Medical Research, LLC
Hollywood, Florida, United States
Tory Sullivan, MD PA
North Miami Beach, Florida, United States
Advanced Medical Research PC
Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
DS Research
Louisville, Kentucky, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Washington University School of Medicine-Dermatology
St Louis, Missouri, United States
Skin Specialists, PC (Schlessinger MD)
Omaha, Nebraska, United States
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire, United States
Aventiv Research Inc.
Dublin, Ohio, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Alberta DermaSurgery Centre
Edmonton, Alberta, Canada
Vida Dermatology
Edmonton, Alberta, Canada
Central Alberta Research Clinic (CARe Clinic)
Red Deer, Alberta, Canada
SimcoDerm Medical and Surgical
Barrie, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.
Québec, , Canada
Kožní ambulance Kutná Hora, s.r.o.
Kutná Hora, , Czechia
Clintrial s.r.o
Prague, , Czechia
Praglandia s.r.o.
Prague, , Czechia
Universitätsklinikum Augsburg Klinik für Dermatologie und Allergologie
Augsburg, , Germany
Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie
Bad Bentheim, , Germany
Uniklinikum Dresden Klinik und Poliklinik für Dermatologie
Dresden, , Germany
Universitätsklinikum Erlangen Hautklinik
Erlangen, , Germany
TFS Trial Form Support GmbH SCIderm - Zentrum für klinische Studien
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel [Zentrum für entzundliche Hauterkrankungen] Klinik für Dermatologie, Venerologie und Allergologie
Kiel, , Germany
Hautarztpraxis Mahlow
Mahlow, , Germany
Klinikum der Universität München Klinik und Poliklinik der Dermatologie und Allergologie Der Universität München
München, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
KliFOs - Klinische Forschung Osnabrück
Osnabrück, , Germany
Hautarztpraxis Dres. Leitz & Kollegen
Stuttgart, , Germany
Semmelweis University, Department of Dermatology, Venerology and Dermatooncology
Budapest, , Hungary
University of Debrecen, Dermatology Department
Debrecen, , Hungary
Bács-Kiskun Megyei KórházSzegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza Bórgyógyászati Szakrendelés
Kecskemét, , Hungary
University of Pecs, Department of Dermatology, Venerology and Oncodermatology
Pécs, , Hungary
Diamond Clinic Spolka z ograniczona odpowiedzialnoscia
Krakow, , Poland
Clinical Best Solutions
Lublin, , Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny
Lublin, , Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
Przychodnia Lekarsko-Psychologinczna Matusiak Spółka Partnerska
Wroclaw, , Poland
DermMedica Sp. z o.o.
Wroclaw, , Poland
Salford Care Organisation
Salford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RIST4721-202
Identifier Type: -
Identifier Source: org_study_id
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