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Trial record 3 of 26 for:    palmoplantar pustulosis

A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

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ClinicalTrials.gov Identifier: NCT03988335
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Aristea Therapeutics, Inc.

Brief Summary:
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
Actual Study Start Date : February 13, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: RIST4721
RIST4721 as once-daily 300mg oral solution for 28 days.
Drug: RIST4721
RIST4721 oral solution

Placebo Comparator: Placebo
Placebo as once-daily 300mg oral solution for 28 days.
Drug: Placebo
Placebo oral solution




Primary Outcome Measures :
  1. Relative change in fresh pustule count [ Time Frame: Baseline to Day 28 ]
  2. Relative change in total pustule count [ Time Frame: Baseline to Day 28 ]

Secondary Outcome Measures :
  1. Absolute change in fresh pustule count [ Time Frame: Baseline to Day 28 ]
  2. Absolute change in total pustule count [ Time Frame: Baseline to Day 28 ]
  3. Proportion of subjects achieving at least a 50% reduction in fresh pustule count [ Time Frame: Baseline to Day 28 ]
  4. Proportion of subjects achieving at least a 50% reduction in total pustule count [ Time Frame: Baseline to Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988335


Contacts
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Contact: Aristea Therapeutics 858-465-6142 info@aristeatx.com

Locations
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Canada, Alberta
Kirk Barber Research Recruiting
Calgary, Alberta, Canada, T2G 1B1
Alberta DermaSurgery Centre Recruiting
Edmonton, Alberta, Canada, T6G 1C3
CARe Clinic (Central Alberta Research Clinic) Recruiting
Red Deer, Alberta, Canada, T4N 6V7
Canada, Manitoba
Winnipeg Clinic Recruiting
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, New Brunswick
Brunswick Dermatology Center Recruiting
Fredericton, New Brunswick, Canada, E3B 1G9
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center Recruiting
Barrie, Ontario, Canada, L4M 7G1
Lynderm Research Inc. Recruiting
Markham, Ontario, Canada, L3P 1X2
North Bay Dermatology Centre Recruiting
North Bay, Ontario, Canada, P1B 3Z7
York Dermatology Center Recruiting
Richmond Hill, Ontario, Canada, L4C 9M7
Dr. Lyne Giroux Medicine Professional Corporation Recruiting
Sudbury, Ontario, Canada, P3A 1W8
Canada, Quebec
Innovaderm Research Inc. Recruiting
Montréal, Quebec, Canada, H2K 4L5
Dre Angelique Gagne-Henley MD Inc. Recruiting
St-Jérôme, Quebec, Canada, J7Z 3B8
Germany
Fachklinik Bad Bentheim Not yet recruiting
Bad Bentheim, Germany, 48455
Rothhaar Studien GmbH Recruiting
Berlin, Germany, 10783
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus Recruiting
Bochum, Germany, 44793
MensingDerma resesearch GmbH Recruiting
Hamburg, Germany, 22391
Hautarztpraxis Dr. Wilfried Steinborn Recruiting
Straubing, Germany, 94315
Sponsors and Collaborators
Aristea Therapeutics, Inc.

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Responsible Party: Aristea Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03988335     History of Changes
Other Study ID Numbers: RIST4721-201
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Aristea Therapeutics, Inc.:
PPP

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Pharmaceutical Solutions