Clinical trial NCT05194839: A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Palmoplantar Pustulosis
Lead sponsor: Aristea Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-18
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Absolute Change From Baseline in PPPGA
timeFrame: Baseline to Week 12
measure: Absolute Change From Baseline in PPPASI
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center, PC
state: Alabama
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, MD PA
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine-Dermatology
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC (Schlessinger MD)
state: Nebraska
city: Portsmouth
country: United States
facility: ALLCUTIS Research, LLC.
state: New Hampshire
city: Dublin
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Pittsburgh
country: United States
facility: UPMC Department of Dermatology
state: Pennsylvania
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre
state: Alberta
city: Edmonton
country: Canada
facility: Vida Dermatology
state: Alberta
city: Red Deer
country: Canada
facility: Central Alberta Research Clinic (CARe Clinic)
state: Alberta
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Québec
country: Canada
facility: Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.
city: Kutná Hora
country: Czechia
facility: Kožní ambulance Kutná Hora, s.r.o.
city: Prague
country: Czechia
facility: Clintrial s.r.o
city: Prague
country: Czechia
facility: Praglandia s.r.o.
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg Klinik für Dermatologie und Allergologie
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie
city: Dresden
country: Germany
facility: Uniklinikum Dresden Klinik und Poliklinik für Dermatologie
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen Hautklinik
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH SCIderm - Zentrum für klinische Studien
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel [Zentrum für entzundliche Hauterkrankungen] Klinik für Dermatologie, Venerologie und Allergologie
city: Mahlow
country: Germany
facility: Hautarztpraxis Mahlow
city: München
country: Germany
facility: Klinikum der Universität München Klinik und Poliklinik der Dermatologie und Allergologie Der Universität München
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
city: Osnabrück
country: Germany
facility: KliFOs - Klinische Forschung Osnabrück
city: Stuttgart
country: Germany
facility: Hautarztpraxis Dres. Leitz & Kollegen
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Dermatology, Venerology and Dermatooncology
city: Debrecen
country: Hungary
facility: University of Debrecen, Dermatology Department
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Megyei KórházSzegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza Bórgyógyászati Szakrendelés
city: Pécs
country: Hungary
facility: University of Pecs, Department of Dermatology, Venerology and Oncodermatology
city: Kraków
country: Poland
facility: Diamond Clinic Spolka z ograniczona odpowiedzialnoscia
city: Lublin
country: Poland
facility: Clinical Best Solutions
city: Lublin
country: Poland
facility: Luxderm Specjalistyczny Gabinet Dermatologiczny
city: Warsaw
country: Poland
facility: Luxderm Specjalistyczny Gabinet Dermatologiczny
city: Warsaw
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Wrocław
country: Poland
facility: Przychodnia Lekarsko-Psychologinczna Matusiak Spółka Partnerska
city: Wrocław
country: Poland
facility: DermMedica Sp. z o.o.
city: Salford
country: United Kingdom
facility: Salford Care Organisation
Study officials:
References: