NCT03139981

A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis

A Randomized, Double -Blind, Placebo-Controlled, Sequential, Multiple-Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of ASN002 In Subjects With Moderate-To-Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Asana BioSciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD).

Detailed description

This study is a dose escalation study to determine a safe and tolerable dose of ASN002 for people with moderate to severe atopic dermatitis. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies. Subjects will also be assessed for improvement in their atopic dermatitis. There will be a screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up with an end-of-study visit.

Conditions

• Dermatitis, Atopic
• Dermatitis Eczema
• Dermatitis, Eczematous

Interventions

Type	Name	Description
DRUG	ASN002	Daily dose of ASN002 for 28 days
DRUG	Placebo Oral Tablet	Placebo for ASN002 for 28 days

Timeline

• Start date: 2017-04-12
• Primary completion: 2017-11-05
• Completion: 2017-12-05
• First posted: 2017-05-04
• Last updated: 2023-05-10

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study