A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
- Registration Number
- NCT05194839
- Lead Sponsor
- Aristea Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 79
- At least 6 months history of moderate or severe PPP, as defined by PPPASI β₯12 and PPPGA β₯3 at screening
- Males and females must be willing to use birth control as indicated
- Moderate to severe psoriasis covering β₯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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RIST4721 400 mg RIST4721 RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks RIST4721 200 mg RIST4721 RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks Placebo Placebo Placebo: 4 placebo tablets once daily for 12 weeks RIST4721 200 mg Placebo RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Proportion of Subjects Achieving a 50% Reduction in PPPASI Score Baseline to Week 12 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).
- Secondary Outcome Measures
Name Time Method Absolute Change From Baseline in PPPGA Baseline to Week 12 Absolute Change From Baseline in PPPASI Baseline to Week 12
Trial Locations
- Locations (50)
Clinical Science Institute
πΊπΈSanta Monica, California, United States
Encore Medical Research, LLC
πΊπΈHollywood, Florida, United States
Aventiv Research Inc.
πΊπΈDublin, Ohio, United States
Central Sooner Research
πΊπΈNorman, Oklahoma, United States
Lynderm Research Inc.
π¨π¦Markham, Ontario, Canada
Driven Research LLC
πΊπΈCoral Gables, Florida, United States
UPMC Department of Dermatology
πΊπΈPittsburgh, Pennsylvania, United States
Total Skin & Beauty Dermatology Center, PC
πΊπΈBirmingham, Alabama, United States
Cosmetic Laser Dermatology
πΊπΈSan Diego, California, United States
Dawes Fretzin Clinical Research Group, LLC
πΊπΈIndianapolis, Indiana, United States
Dermatology Clinical Research Center of San Antonio
πΊπΈSan Antonio, Texas, United States
Dermatology Trial Associates
πΊπΈBryant, Arkansas, United States
Tory Sullivan, MD PA
πΊπΈNorth Miami Beach, Florida, United States
Advanced Medical Research PC
πΊπΈSandy Springs, Georgia, United States
Great Lakes Research Group, Inc.
πΊπΈBay City, Michigan, United States
Washington University School of Medicine-Dermatology
πΊπΈSaint Louis, Missouri, United States
ALLCUTIS Research, LLC.
πΊπΈPortsmouth, New Hampshire, United States
Apex Clinical Research Center
πΊπΈMayfield Heights, Ohio, United States
Alberta DermaSurgery Centre
π¨π¦Edmonton, Alberta, Canada
Vida Dermatology
π¨π¦Edmonton, Alberta, Canada
Central Alberta Research Clinic (CARe Clinic)
π¨π¦Red Deer, Alberta, Canada
SimcoDerm Medical and Surgical
π¨π¦Barrie, Ontario, Canada
Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.
π¨π¦QuΓ©bec, Canada
KoΕΎnΓ ambulance KutnΓ‘ Hora, s.r.o.
π¨πΏKutnΓ‘ Hora, Czechia
Clintrial s.r.o
π¨πΏPrague, Czechia
Praglandia s.r.o.
π¨πΏPrague, Czechia
TFS Trial Form Support GmbH SCIderm - Zentrum fΓΌr klinische Studien
π©πͺHamburg, Germany
UniversitΓ€tsklinikum Augsburg Klinik fΓΌr Dermatologie und Allergologie
π©πͺAugsburg, Germany
Uniklinikum Dresden Klinik und Poliklinik fΓΌr Dermatologie
π©πͺDresden, Germany
UniversitΓ€tsklinikum Erlangen Hautklinik
π©πͺErlangen, Germany
Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie
π©πͺBad Bentheim, Germany
UniversitΓ€tsklinikum Schleswig-Holstein, Campus Kiel [Zentrum fΓΌr entzundliche Hauterkrankungen] Klinik fΓΌr Dermatologie, Venerologie und Allergologie
π©πͺKiel, Germany
Hautarztpraxis Mahlow
π©πͺMahlow, Germany
Klinikum der UniversitΓ€t MΓΌnchen Klinik und Poliklinik der Dermatologie und Allergologie Der UniversitΓ€t MΓΌnchen
π©πͺMΓΌnchen, Germany
KliFOs - Klinische Forschung OsnabrΓΌck
π©πͺOsnabrΓΌck, Germany
Universitaetsklinikum Muenster
π©πͺMΓΌnster, Germany
Hautarztpraxis Dres. Leitz & Kollegen
π©πͺStuttgart, Germany
University of Debrecen, Dermatology Department
ππΊDebrecen, Hungary
Semmelweis University, Department of Dermatology, Venerology and Dermatooncology
ππΊBudapest, Hungary
University of Pecs, Department of Dermatology, Venerology and Oncodermatology
ππΊPΓ©cs, Hungary
BΓ‘cs-Kiskun Megyei KΓ³rhΓ‘zSzegedi TudomΓ‘nyegyetem ΓltalΓ‘nos OrvostudomΓ‘nyi Kar OktatΓ³ KΓ³rhΓ‘za BΓ³rgyΓ³gyΓ‘szati SzakrendelΓ©s
ππΊKecskemΓ©t, Hungary
Przychodnia Lekarsko-Psychologinczna Matusiak SpΓ³Εka Partnerska
π΅π±WrocΕaw, Poland
Diamond Clinic Spolka z ograniczona odpowiedzialnoscia
π΅π±KrakΓ³w, Poland
Clinical Best Solutions
π΅π±Lublin, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny
π΅π±Warsaw, Poland
Royalderm Agnieszka Nawrocka
π΅π±Warsaw, Poland
DermMedica Sp. z o.o.
π΅π±WrocΕaw, Poland
Salford Care Organisation
π¬π§Salford, United Kingdom
Skin Specialists, PC (Schlessinger MD)
πΊπΈOmaha, Nebraska, United States
DS Research
πΊπΈLouisville, Kentucky, United States