NCT03654755

Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Asana BioSciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

Detailed description

This is a randomized open label study where subjects with moderate to severe atopic dermatitis will roll over from the Phase 1 ASN002AD-101 (NCT03139981) and ASN002AD-201 (NCT03531957) Ph2b study and be randomized to receive ASN002 at 40mg, 60mg, or 80mg once daily for up to 24 months. This study will also characterize the pharmacokinetics of ASN002 through blood sampling from subjects who consent.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	ASN002	Daily dose of ASN002 for up to 110 weeks

Timeline

• Start date: 2018-09-29
• Primary completion: 2019-10-29
• Completion: 2019-10-29
• First posted: 2018-08-31
• Last updated: 2023-09-18
• Results posted: 2023-09-18

Locations

38 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study