Palmoplantar PustulosisPhase 2NCT05194839
A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
A Phase 2 study testing RIST4721 in people with Palmoplantar Pustulosis, run by Aristea Therapeutics, Inc. at 51 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Palmoplantar Pustulosis
- What is being tested?
- RIST4721
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 51 sitesin 7 countries
- Study dates
- 5 Jan 2022to 6 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
51 sites in 7 countries.
51 sites in 7 countries
United States19 sites
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Dermatology Trial Associates
Bryant, Arkansas, 72022
Driven Research LLC
Coral Gables, Florida, 33134
Aventiv Research Inc.
Dublin, Ohio, 43016
Encore Medical Research, LLC
Hollywood, Florida, 33021
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
DS Research
Louisville, Kentucky, 40241
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
Central Sooner Research
Norman, Oklahoma, 73071
Tory Sullivan, MD PA
North Miami Beach, Florida, 33162
Skin Specialists, PC (Schlessinger MD)
Omaha, Nebraska, 68144
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15212
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire, 03801
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Cosmetic Laser Dermatology
San Diego, California, 92121
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Clinical Science Institute
Santa Monica, California, 90404
Washington University School of Medicine-Dermatology
St Louis, Missouri, 63108
Germany11 sites
Universitätsklinikum Augsburg Klinik für Dermatologie und Allergologie
Augsburg, 86156
Fachklinik Bad Bentheim Fachbereich Dermatologie und Allergologie
Bad Bentheim, 48455
Uniklinikum Dresden Klinik und Poliklinik für Dermatologie
Dresden, 01307
Universitätsklinikum Erlangen Hautklinik
Erlangen, 91054
TFS Trial Form Support GmbH SCIderm - Zentrum für klinische Studien
Hamburg, 20537
Universitätsklinikum Schleswig-Holstein, Campus Kiel [Zentrum für entzundliche Hauterkrankungen] Klinik für Dermatologie, Venerologie und Allergologie
Kiel, 24105
Hautarztpraxis Mahlow
Mahlow, 15831
Klinikum der Universität München Klinik und Poliklinik der Dermatologie und Allergologie Der Universität München
München, 80337
Universitaetsklinikum Muenster
Münster, 48149
KliFOs - Klinische Forschung Osnabrück
Osnabrück, 49074
Hautarztpraxis Dres. Leitz & Kollegen
Stuttgart, 70178
Poland7 sites
Diamond Clinic Spolka z ograniczona odpowiedzialnoscia
Krakow, 31-559
Clinical Best Solutions
Lublin, 20-078
Luxderm Specjalistyczny Gabinet Dermatologiczny
Lublin, 20-573
Luxderm Specjalistyczny Gabinet Dermatologiczny
Warsaw, 01-142
Royalderm Agnieszka Nawrocka
Warsaw, 02-962
Przychodnia Lekarsko-Psychologinczna Matusiak Spółka Partnerska
Wroclaw, 50-566
DermMedica Sp. z o.o.
Wroclaw, 51-318
Canada6 sites
SimcoDerm Medical and Surgical
Barrie, Ontario, L4M 7G1
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G 1C3
Vida Dermatology
Edmonton, Alberta, T6H 4JB
Lynderm Research Inc.
Markham, Ontario, L3P 1X3
Centre De Recherche Dermatologique Du Quebec Metropolitan Inc.
Québec, G1V 4X7
Central Alberta Research Clinic (CARe Clinic)
Red Deer, Alberta, T4P 1K4
Hungary4 sites
Semmelweis University, Department of Dermatology, Venerology and Dermatooncology
Budapest, 1085
University of Debrecen, Dermatology Department
Debrecen, 4012
Bács-Kiskun Megyei KórházSzegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza Bórgyógyászati Szakrendelés
Kecskemét, 6000
University of Pecs, Department of Dermatology, Venerology and Oncodermatology
Pécs, 7632
Czechia3 sites
Kožní ambulance Kutná Hora, s.r.o.
Kutná Hora, 284 01
Clintrial s.r.o
Prague, 100 00
Praglandia s.r.o.
Prague, 150 00
About this study
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
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.
- Conditions
- Palmoplantar Pustulosis
- Being tested
- RIST4721, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIST4721Drug
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| RIST4721 400 mg | Experimental | RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks Receives: Drug: RIST4721 |
| RIST4721 200 mg | Experimental | RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks Receives: Drug: RIST4721; Drug: Placebo |
| Placebo | Placebo comparator | Placebo: 4 placebo tablets once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Week 12
Secondary outcomes (2)
Absolute Change From Baseline in PPPGA
Measured: Baseline to Week 12
Absolute Change From Baseline in PPPASI
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start5 Jan 2022
- Primary completion13 Feb 2023
- Study completion6 Mar 2023
Why it stopped: Due to safety findings in ongoing Phase 2 trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Palmoplantar PustulosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristea Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194839
- Sponsor's protocol ID
- RIST4721-202
- Status last verified
- Jun 2023
- First submitted
- 4 Jan 2022
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05194839
- Acronym / sponsor ID
- RIST4721-202
- Conditions
- Palmoplantar Pustulosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to safety findings in ongoing Phase 2 trials.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Aristea Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Posted 29 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RIST4721 400 mg | Experimental | Drug: RIST4721RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks |
| RIST4721 200 mg | Experimental | Drug: RIST4721, Drug: PlaceboRIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: 4 placebo tablets once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIST4721RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets | Drug | RIST4721 200 mg, RIST4721 400 mg |
| PlaceboMatching placebo | Drug | Placebo, RIST4721 200 mg |
Primary outcome
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
Time frame: 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).
2 secondary outcomes
Absolute Change From Baseline in PPPGA
Time frame: Baseline to Week 12
Absolute Change From Baseline in PPPASI
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RIST4721 in people with Palmoplantar Pustulosis, run by Aristea Therapeutics, Inc. at 51 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Germany, Poland, Canada, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.