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

Palmoplantar Pustulosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05194839
• Other study ID #: RIST4721-202
• Status: Terminated
• Phase: Phase 2
• Start date: January 5, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: June 2023
• Source: Aristea Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: March 6, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Palmoplantar Pustulosis
• Psoriasis

Intervention

Drug:
• RIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
• Placebo
Matching placebo

Locations

Country	Name	City	State
Canada	SimcoDerm Medical and Surgical	Barrie	Ontario
Canada	Alberta DermaSurgery Centre	Edmonton	Alberta
Canada	Vida Dermatology	Edmonton	Alberta
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.	Québec
Canada	Central Alberta Research Clinic (CARe Clinic)	Red Deer	Alberta
Czechia	Kožní ambulance Kutná Hora, s.r.o.	Kutná Hora
Czechia	Clintrial s.r.o	Prague
Czechia	Praglandia s.r.o.	Prague
Germany	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
Hungary	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
Poland	Diamond Clinic Spolka z ograniczona odpowiedzialnoscia	Kraków
Poland	Clinical Best Solutions	Lublin
Poland	Luxderm Specjalistyczny Gabinet Dermatologiczny	Lublin
Poland	Luxderm Specjalistyczny Gabinet Dermatologiczny	Warsaw
Poland	Royalderm Agnieszka Nawrocka	Warsaw
Poland	DermMedica Sp. z o.o.	Wroclaw
Poland	Przychodnia Lekarsko-Psychologinczna Matusiak Spólka Partnerska	Wroclaw
United Kingdom	Salford Care Organisation	Salford
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Total Skin & Beauty Dermatology Center, PC	Birmingham	Alabama
United States	Dermatology Trial Associates	Bryant	Arkansas
United States	Driven Research LLC	Coral Gables	Florida
United States	Aventiv Research Inc.	Dublin	Ohio
United States	Encore Medical Research, LLC	Hollywood	Florida
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	DS Research	Louisville	Kentucky
United States	Apex Clinical Research Center	Mayfield Heights	Ohio
United States	Central Sooner Research	Norman	Oklahoma
United States	Tory Sullivan, MD PA	North Miami Beach	Florida
United States	Skin Specialists, PC (Schlessinger MD)	Omaha	Nebraska
United States	UPMC Department of Dermatology	Pittsburgh	Pennsylvania
United States	ALLCUTIS Research, LLC.	Portsmouth	New Hampshire
United States	Washington University School of Medicine-Dermatology	Saint Louis	Missouri
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Cosmetic Laser Dermatology	San Diego	California
United States	Advanced Medical Research PC	Sandy Springs	Georgia
United States	Clinical Science Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Aristea Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Hungary,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absolute Change From Baseline in PPPGA		Baseline to Week 12
Secondary	Absolute Change From Baseline in PPPASI		Baseline to Week 12