A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

Aristea Therapeutics

Status and phase: Completed; Phase 2

Conditions: Palmoplantar Pustulosis

Treatments: Drug: Placebo; Drug: RIST4721

Study type: Interventional

Funder types: Industry

Identifiers

NCT03988335

RIST4721-201

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

RIST4721

Experimental group

Description:

RIST4721 as once-daily 300mg oral solution for 28 days.

Treatment:

Drug: RIST4721

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo