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

Sponsor

Aristea Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05194839

Collaborator

(none)

156

Enrollment

Locations

Arms

16.8

Anticipated Duration (Months)

4.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Palmoplantar Pustulosis	Drug: RIST4721 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double-blind

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 5, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RIST4721 400 mg RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks	Drug: RIST4721 RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Experimental: RIST4721 200 mg RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks	Drug: RIST4721 RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets Drug: Placebo Matching placebo
Placebo Comparator: Placebo Placebo: 4 placebo tablets once daily for 12 weeks	Drug: Placebo Matching placebo

Arm

Intervention/Treatment

Experimental: RIST4721 400 mg

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

Drug: RIST4721

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

Experimental: RIST4721 200 mg

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

Drug: RIST4721

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

Drug: Placebo

Matching placebo

Placebo Comparator: Placebo

Placebo: 4 placebo tablets once daily for 12 weeks

Drug: Placebo

Matching placebo

Outcome Measures

Primary Outcome Measures

Proportion of subjects achieving a 50% reduction in PPPASI score [Baseline to Week 12]

Secondary Outcome Measures

Absolute change from baseline in PPPGA [Baseline to Week 12]
Absolute change from baseline in PPPASI [Baseline to Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 74 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Total Skin & Beauty Dermatology Center, PC	Birmingham	Alabama	United States	35205
2	Dermatology Trial Associates	Bryant	Arkansas	United States	72022
3	Cosmetic Laser Dermatology	San Diego	California	United States	92121
4	Clinical Science Institute	Santa Monica	California	United States	90404
5	Driven Research LLC	Coral Gables	Florida	United States	33134
6	Encore Medical Research, LLC	Hollywood	Florida	United States	33021
7	Tory Sullivan, MD PA	North Miami Beach	Florida	United States	33162
8	Advanced Medical Research PC	Sandy Springs	Georgia	United States	30328
9	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46250
10	DS Research	Louisville	Kentucky	United States	40241
11	Great Lakes Research Group, Inc.	Bay City	Michigan	United States	48706
12	Washington University School of Medicine-Dermatology	Saint Louis	Missouri	United States	63108
13	Skin Specialists, PC (Schlessinger MD)	Omaha	Nebraska	United States	68144
14	ALLCUTIS Research, LLC.	Portsmouth	New Hampshire	United States	03801
15	Aventiv Research Inc.	Dublin	Ohio	United States	43016
16	Apex Clinical Research Center	Mayfield Heights	Ohio	United States	44124
17	Central Sooner Research	Norman	Oklahoma	United States	73071
18	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
19	Alberta DermaSurgery Centre	Edmonton	Alberta	Canada	T6G 1C3
20	Vida Dermatology	Edmonton	Alberta	Canada	T6H 4JB
21	Central Alberta Research Clinic (CARe Clinic)	Red Deer	Alberta	Canada	T4P 1K4
22	SimcoDerm Medical and Surgical	Barrie	Ontario	Canada	L4M 7G1
23	Lynderm Research Inc.	Markham	Ontario	Canada	L3P 1X3
24	Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie	Bad Bentheim		Germany	48455
25	Universitätsklinikum Erlangen Hautklinik	Erlangen		Germany	91054
26	TFS Trial Form Support GmbH SCIderm - Zentrum für klinische Studien	Hamburg		Germany	20537
27	Universitätsklinikum Schleswig-Holstein, Campus Kiel [Zentrum für entzundliche Hauterkrankungen] Klinik für Dermatologie, Venerologie und Allergologie	Kiel		Germany	24105
28	Hautarztpraxis Mahlow	Mahlow		Germany	15831
29	Universitaetsklinikum Muenster	Münster		Germany	48149
30	KliFOs - Klinische Forschung Osnabrück	Osnabrück		Germany	49074
31	Diamond Clinic Spolka z ograniczona odpowiedzialnoscia	Kraków		Poland	31-559
32	Clinical Best Solutions	Lublin		Poland	20-078
33	Luxderm Specjalistyczny Gabinet Dermatologiczny	Lublin		Poland	20-573
34	Luxderm Specjalistyczny Gabinet Dermatologiczny	Warsaw		Poland	01-142
35	Royalderm Agnieszka Nawrocka	Warsaw		Poland	02-962
36	DermMedica Sp. z o.o.	Wrocław		Poland	51-318

Sponsors and Collaborators

Aristea Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aristea Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT05194839

Other Study ID Numbers:

RIST4721-202

First Posted:

Jan 18, 2022

Last Update Posted:

Aug 9, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Psoriasis

Study Results

No Results Posted as of Aug 9, 2022