Palmoplantar PustulosisPhase 2NCT03988335
A 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 17 sites in 2 countries.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 35 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 13 Feb 2019to 19 Nov 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles
- Moderate or severe PPP, as defined by Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) ≥8 and Palmoplantar Pustulosis Physician Global Assessment (PPPGA) ≥3 at Day -1, and a minimum of 8 fresh pustules at screening (fresh pustule count on both right/left palms and soles) and 20 fresh pustules at Day -1 (fresh pustule count on both right/left palms and soles)
- Males and females must be willing to use birth control as indicated
Who cannot join
- Moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of total Body Surface Area (BSA) at Day -1
- Subject is known to have an immune deficiency or is immunocompromised
- Positive test for hepatitis, human immunodeficiency virus (HIV) or tuberculosis
- Use of topical therapies for PPP within 2 weeks of Day -1 and/or systemic therapies for PPP within 4 weeks
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Canada12 sites
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Kirk Barber Research
Calgary, Alberta, T2G 1B1
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G 1C3
Brunswick Dermatology Center
Fredericton, New Brunswick, E3B 1G9
Dr. Lyne Giroux Medicine Professional Corporation
Greater Sudbury, Ontario, P3A 1W8
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
CARe Clinic (Central Alberta Research Clinic)
Red Deer, Alberta, T4N 6V7
York Dermatology Center
Richmond Hill, Ontario, L4C 9M7
Dre Angelique Gagne-Henley MD Inc.
Saint-Jérôme, Quebec, J7Z 3B8
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Germany5 sites
Fachklinik Bad Bentheim
Bad Bentheim, 48455
Rothhaar Studien GmbH
Berlin, 10783
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
Bochum, 44793
MensingDerma research GmbH
Hamburg, 22391
Hautarztpraxis Dr. Wilfried Steinborn
Straubing, 94315
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
- Conditions
- Palmoplantar Pustulosis
- Being tested
- RIST4721, Placebo
- Keywords
- PPP
- 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 oral solution
PlaceboDrug
Placebo oral solution
| Study group | Role | What they receive |
|---|---|---|
| RIST4721 | Experimental | RIST4721 as once-daily 300mg oral solution for 28 days. Receives: Drug: RIST4721 |
| Placebo | Placebo comparator | Placebo as once-daily 300mg oral solution for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
Relative change from baseline in fresh pustule count at Day 28
Measured: Baseline to Day 28
Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline
Relative change from baseline in total pustule count at Day 28
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start13 Feb 2019
- Primary completion5 Nov 2019
- Study completion19 Nov 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 35 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
- NCT03988335
- Sponsor's protocol ID
- RIST4721-201
- Status last verified
- Mar 2022
- First submitted
- 13 Jun 2019
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bissonnette R, Maari C, Tsianakas A, Reid D, McCutchan S, Baumgartner S, Mackay J, Bhakta N. A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2179-2193. doi: 10.1007/s13555-021-00632-7. Epub 2021 Oct 30.
PubMed 34716902
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
- ClinicalTrials.gov ID
- NCT03988335
- Acronym / sponsor ID
- RIST4721-201
- Conditions
- Palmoplantar Pustulosis
- Keywords
- PPP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Aristea Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Posted 3 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIST4721 | Experimental | Drug: RIST4721RIST4721 as once-daily 300mg oral solution for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo as once-daily 300mg oral solution for 28 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles
- Moderate or severe PPP, as defined by Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) ≥8 and Palmoplantar Pustulosis Physician Global Assessment (PPPGA) ≥3 at Day -1, and a minimum of 8 fresh pustules at screening (fresh pustule count on both right/left palms and soles) and 20 fresh pustules at Day -1 (fresh pustule count on both right/left palms and soles)
- Males and females must be willing to use birth control as indicated
Key exclusion criteria (4 listed)
- Moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of total Body Surface Area (BSA) at Day -1
- Subject is known to have an immune deficiency or is immunocompromised
- Positive test for hepatitis, human immunodeficiency virus (HIV) or tuberculosis
- Use of topical therapies for PPP within 2 weeks of Day -1 and/or systemic therapies for PPP within 4 weeks
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 oral solution | Drug | RIST4721 |
| PlaceboPlacebo oral solution | Drug | Placebo |
Primary outcome
Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
Time frame: Baseline to Day 28
Relative change from baseline in fresh pustule count at Day 28
Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline
Time frame: Baseline to Day 28
Relative change from baseline in total pustule count at Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34716902Bissonnette R, Maari C, Tsianakas A, Reid D, McCutchan S, Baumgartner S, Mackay J, Bhakta N. A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2179-2193. doi: 10.1007/s13555-021-00632-7. Epub 2021 Oct 30.
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar PustulosisLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Palmoplantar Pustulosis
Not yet recruitingPhase 2
A Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis
Palmoplantar Pustulosis of Adults
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 2
A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis
Palmoplantar Pustulosis
Active, not recruitingObservational study
A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis
Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Generalized Pustular Psoriasis, Erythrodermic Psoriasis
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.
17 sites in 2 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 17 sites in 2 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada, Germany. 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 3 Mar 2022). 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?
Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline (time frame: Baseline to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03988335, which also lists 1 linked publication.
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 5 Apr 2022.