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

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: Terminated
• Conditions: Palmoplantar Pustulosis
• Intervention / Treatment: Drug: Placebo; Drug: RIST4721

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

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
    • Universitatsklinikum 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 Osnabruck
  • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score	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

Outcome Measure	Time Frame
Absolute Change From Baseline in PPPGA	Baseline to Week 12
Absolute Change From Baseline in PPPASI	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Aristea Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID 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