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

Primary Purpose

Palmoplantar Pustulosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RIST4721
Placebo
Sponsored by
Aristea Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palmoplantar Pustulosis

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Total Skin & Beauty Dermatology Center, PC
  • Dermatology Trial Associates
  • Cosmetic Laser Dermatology
  • Clinical Science Institute
  • Driven Research LLC
  • Encore Medical Research, LLC
  • Tory Sullivan, MD PA
  • Advanced Medical Research PC
  • Dawes Fretzin Clinical Research Group, LLC
  • DS Research
  • Great Lakes Research Group, Inc.
  • Washington University School of Medicine-Dermatology
  • Skin Specialists, PC (Schlessinger MD)
  • ALLCUTIS Research, LLC.
  • Aventiv Research Inc.
  • Apex Clinical Research Center
  • Central Sooner Research
  • UPMC Department of Dermatology
  • Dermatology Clinical Research Center of San Antonio
  • Alberta DermaSurgery Centre
  • Vida Dermatology
  • Central Alberta Research Clinic (CARe Clinic)
  • SimcoDerm Medical and Surgical
  • Lynderm Research Inc.
  • Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.
  • Kožní ambulance Kutná Hora, s.r.o.
  • Clintrial s.r.o
  • Praglandia s.r.o.
  • Universitätsklinikum Augsburg Klinik für Dermatologie und Allergologie
  • Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie
  • Uniklinikum Dresden Klinik und Poliklinik für Dermatologie
  • Universitätsklinikum Erlangen Hautklinik
  • TFS Trial Form Support GmbH SCIderm - Zentrum für klinische Studien
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel [Zentrum für entzundliche Hauterkrankungen] Klinik für Dermatologie, Venerologie und Allergologie
  • Hautarztpraxis Mahlow
  • Klinikum der Universität München Klinik und Poliklinik der Dermatologie und Allergologie Der Universität München
  • Universitaetsklinikum Muenster
  • KliFOs - Klinische Forschung Osnabrück
  • Hautarztpraxis Dres. Leitz & Kollegen
  • Semmelweis University, Department of Dermatology, Venerology and Dermatooncology
  • University of Debrecen, Dermatology Department
  • Bács-Kiskun Megyei KórházSzegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza Bórgyógyászati Szakrendelés
  • University of Pecs, Department of Dermatology, Venerology and Oncodermatology
  • Diamond Clinic Spolka z ograniczona odpowiedzialnoscia
  • Clinical Best Solutions
  • Luxderm Specjalistyczny Gabinet Dermatologiczny
  • Luxderm Specjalistyczny Gabinet Dermatologiczny
  • Royalderm Agnieszka Nawrocka
  • Przychodnia Lekarsko-Psychologinczna Matusiak Spółka Partnerska
  • DermMedica Sp. z o.o.
  • Salford Care Organisation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RIST4721 400 mg

RIST4721 200 mg

Placebo

Arm Description

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

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

Placebo: 4 placebo tablets once daily for 12 weeks

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Absolute Change From Baseline in PPPGA
Absolute Change From Baseline in PPPASI

Full Information

First Posted
January 4, 2022
Last Updated
June 28, 2023
Sponsor
Aristea Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05194839
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to safety findings in ongoing Phase 2 trials.
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
February 13, 2023 (Actual)
Study Completion Date
March 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aristea Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantar Pustulosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIST4721 400 mg
Arm Type
Experimental
Arm Description
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
Arm Title
RIST4721 200 mg
Arm Type
Experimental
Arm Description
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: 4 placebo tablets once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
RIST4721
Intervention Description
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
Description
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).
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline in PPPGA
Time Frame
Baseline to Week 12
Title
Absolute Change From Baseline in PPPASI
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Total Skin & Beauty Dermatology Center, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Dermatology Trial Associates
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Cosmetic Laser Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Driven Research LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Encore Medical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Tory Sullivan, MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Advanced Medical Research PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Washington University School of Medicine-Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Skin Specialists, PC (Schlessinger MD)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
ALLCUTIS Research, LLC.
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Aventiv Research Inc.
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Apex Clinical Research Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
UPMC Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Alberta DermaSurgery Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
Vida Dermatology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6H 4JB
Country
Canada
Facility Name
Central Alberta Research Clinic (CARe Clinic)
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P 1K4
Country
Canada
Facility Name
SimcoDerm Medical and Surgical
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.
City
Québec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Kožní ambulance Kutná Hora, s.r.o.
City
Kutná Hora
ZIP/Postal Code
284 01
Country
Czechia
Facility Name
Clintrial s.r.o
City
Prague
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Praglandia s.r.o.
City
Prague
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Universitätsklinikum Augsburg Klinik für Dermatologie und Allergologie
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Uniklinikum Dresden Klinik und Poliklinik für Dermatologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Erlangen Hautklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
TFS Trial Form Support GmbH SCIderm - Zentrum für klinische Studien
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel [Zentrum für entzundliche Hauterkrankungen] Klinik für Dermatologie, Venerologie und Allergologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Hautarztpraxis Mahlow
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Klinikum der Universität München Klinik und Poliklinik der Dermatologie und Allergologie Der Universität München
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
KliFOs - Klinische Forschung Osnabrück
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Hautarztpraxis Dres. Leitz & Kollegen
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
Semmelweis University, Department of Dermatology, Venerology and Dermatooncology
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
University of Debrecen, Dermatology Department
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Bács-Kiskun Megyei KórházSzegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza Bórgyógyászati Szakrendelés
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
University of Pecs, Department of Dermatology, Venerology and Oncodermatology
City
Pécs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Diamond Clinic Spolka z ograniczona odpowiedzialnoscia
City
Kraków
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Clinical Best Solutions
City
Lublin
ZIP/Postal Code
20-078
Country
Poland
Facility Name
Luxderm Specjalistyczny Gabinet Dermatologiczny
City
Lublin
ZIP/Postal Code
20-573
Country
Poland
Facility Name
Luxderm Specjalistyczny Gabinet Dermatologiczny
City
Warsaw
ZIP/Postal Code
01-142
Country
Poland
Facility Name
Royalderm Agnieszka Nawrocka
City
Warsaw
ZIP/Postal Code
02-962
Country
Poland
Facility Name
Przychodnia Lekarsko-Psychologinczna Matusiak Spółka Partnerska
City
Wrocław
ZIP/Postal Code
50-566
Country
Poland
Facility Name
DermMedica Sp. z o.o.
City
Wrocław
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Salford Care Organisation
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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