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

NCT05194839 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: RIST4721-202
• Study Type: interventional
• Target: 79
• Locations: 7 countries
• Sites: 51

Brief Summary

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.

Conditions

Palmoplantar Pustulosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Absolute Change From Baseline in PPPGA

  Baseline to Week 12

• Absolute Change From Baseline in PPPASI

  Baseline to Week 12

Study Arms (3)

RIST4721 400 mg

EXPERIMENTAL

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

Drug: RIST4721

RIST4721 200 mg

EXPERIMENTAL

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

Drug: RIST4721; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo: 4 placebo tablets once daily for 12 weeks

Drug: Placebo

Interventions

RIST4721 DRUG

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

RIST4721 200 mg; RIST4721 400 mg

Placebo DRUG

Matching placebo

Placebo; RIST4721 200 mg

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristea Therapeutics, Inc.: lead

Study Sites (51)

Total Skin & Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Driven Research LLC

Coral Gables, Florida, 33134, United States

Location

Encore Medical Research, LLC

Hollywood, Florida, 33021, United States

Location

Tory Sullivan, MD PA

North Miami Beach, Florida, 33162, United States

Location

Advanced Medical Research PC

Sandy Springs, Georgia, 30328, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Washington University School of Medicine-Dermatology

St Louis, Missouri, 63108, United States

Location

Skin Specialists, PC (Schlessinger MD)

Omaha, Nebraska, 68144, United States

Location

ALLCUTIS Research, LLC.

Portsmouth, New Hampshire, 03801, United States

Location

Aventiv Research Inc.

Dublin, Ohio, 43016, United States

Location

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15212, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Alberta DermaSurgery Centre

Edmonton, Alberta, T6G 1C3, Canada

Location

Vida Dermatology

Edmonton, Alberta, T6H 4JB, Canada

Location

Central Alberta Research Clinic (CARe Clinic)

Red Deer, Alberta, T4P 1K4, Canada

Location

SimcoDerm Medical and Surgical

Barrie, Ontario, L4M 7G1, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.

Québec, G1V 4X7, Canada

Location

Kožní ambulance Kutná Hora, s.r.o.

Kutná Hora, 284 01, Czechia

Location

Clintrial s.r.o

Prague, 100 00, Czechia

Location

Praglandia s.r.o.

Prague, 150 00, Czechia

Location

Universitätsklinikum Augsburg Klinik für Dermatologie und Allergologie

Augsburg, 86156, Germany

Location

Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie

Bad Bentheim, 48455, Germany

Location

Uniklinikum Dresden Klinik und Poliklinik für Dermatologie

Dresden, 01307, Germany

Location

Universitätsklinikum Erlangen Hautklinik

Erlangen, 91054, Germany

Location

TFS Trial Form Support GmbH SCIderm - Zentrum für klinische Studien

Hamburg, 20537, Germany

Location

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

Kiel, 24105, Germany

Location

Hautarztpraxis Mahlow

Mahlow, 15831, Germany

Location

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

München, 80337, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

KliFOs - Klinische Forschung Osnabrück

Osnabrück, 49074, Germany

Location

Hautarztpraxis Dres. Leitz & Kollegen

Stuttgart, 70178, Germany

Location

Semmelweis University, Department of Dermatology, Venerology and Dermatooncology

Budapest, 1085, Hungary

Location

University of Debrecen, Dermatology Department

Debrecen, 4012, Hungary

Location

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

Kecskemét, 6000, Hungary

Location

University of Pecs, Department of Dermatology, Venerology and Oncodermatology

Pécs, 7632, Hungary

Location

Diamond Clinic Spolka z ograniczona odpowiedzialnoscia

Krakow, 31-559, Poland

Location

Clinical Best Solutions

Lublin, 20-078, Poland

Location

Luxderm Specjalistyczny Gabinet Dermatologiczny

Lublin, 20-573, Poland

Location

Luxderm Specjalistyczny Gabinet Dermatologiczny

Warsaw, 01-142, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02-962, Poland

Location

Przychodnia Lekarsko-Psychologinczna Matusiak Spółka Partnerska

Wroclaw, 50-566, Poland

Location

DermMedica Sp. z o.o.

Wroclaw, 51-318, Poland

Location

Salford Care Organisation

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Aristea Therapeutics
• Organization: Aristea Therapeutics

info@aristeatx.com

858-465-6142

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: January 5, 2022
• Primary Completion: February 13, 2023
• Study Completion: March 6, 2023
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); DE (11); HU (4); CZ (3); PL (7); GB (1); CA (6)