A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

Aristea Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Palmoplantar Pustulosis

Treatments: Drug: Placebo; Drug: RIST4721

Study type: Interventional

Funder types: Industry

Identifiers

NCT05194839

RIST4721-202

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 3 patient groups, including a placebo group

RIST4721 400 mg

Experimental group

Description:

RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks

Treatment:

Drug: RIST4721

RIST4721 200 mg

Experimental group

Description:

RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks

Treatment:

Drug: RIST4721

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo: 4 placebo tablets once daily for 12 weeks

Treatment:

Drug: Placebo