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Completed

NCT Number: NCT03988335

A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis

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Key information

Conditions

Palmoplantar Pustulosis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kirk Barber Research, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIST4721

Drug

RIST4721 oral solution

Placebo

Drug

Placebo oral solution

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Aristea Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2019
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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