drugset / Trial / NCT05870865

A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis

NCT05870865 ↗

Phase 2 Completed 144 enrolled Formation Bio, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to evaluate ASN008 in people with itch caused by eczema. The main questions it aims to answer are: * What is the efficacy and safety of ASN008? * What is the impact of ASN008 on itch in patients with atopic dermatitis? Participants will be asked to apply topical ASN008, or matching vehicle (placebo containing no active drug), to their eczema lesions twice daily for 4 weeks. Researchers will compare 3 different doses of ASN008 and a matching vehicle group to see which group responds best.

Timeline

Start
2023-05-03
Primary completion
2023-11-27
Completion
2023-12-28

Outcome

Missed primary endpoint

registry analysis (superiority test); ASN008 1.25% vs ASN008 Matching Vehicle; p = 0.5483 NCT05870865 ↗

registry analysis (superiority test); ASN008 2.5% vs ASN008 Matching Vehicle; p = 0.4123 NCT05870865 ↗

registry analysis (superiority test); ASN008 5% vs ASN008 Matching Vehicle; p = 0.8177 NCT05870865 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ASN008 Unknown 1.25 % Topical
Subject ASN008 Unknown 2.5 % Topical
Subject ASN008 Unknown 5 % Topical

Indications