NCT03728504

Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Asana BioSciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.

Detailed description

This is a placebo controlled study where subjects with severe chronic hand eczema will be randomized (1:1:1) to receive ASN002 at 40 mg, 80 mg, or placebo once daily for 16 weeks (Part A). Then, in Part B, subjects who were assigned to placebo in the first part of the study will receive the highest dose of ASN002 (80 mg) for the rest of the treatment period (up to Week 32). The subjects who were assigned ASN002 in the first part of the study will continue on the same assigned treatment dose during the second part of the study (Week 16 to Week 32). The total treatment period of 32 weeks will be followed by a 4 week follow-up period.This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.

Conditions

• Chronic Hand Dermatitis

Interventions

Type	Name	Description
DRUG	ASN002	Daily dose of ASN002 for 32 weeks
DRUG	Placebo Oral Tablet	Daily dose of Placebo Oral Tablet for 16 weeks

Timeline

• Start date: 2019-01-03
• Primary completion: 2020-04-29
• Completion: 2020-04-29
• First posted: 2018-11-02
• Last updated: 2023-05-09
• Results posted: 2023-05-09

Locations

23 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study