NCT03531957

Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)

A Randomized, Double-blind, Placebo-controlled, Phase 2B Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Asana BioSciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

Detailed description

This is a placebo controlled study where subjects with moderate to severe atopic dermatitis will be randomized (1:1:1:1) to receive ASN002 at 40 mg, 60 mg, or 80 mg, or placebo once daily for 12 weeks. Eligible subjects will get the opportunity to enroll in the 24 month open-label extension study (OLE). There will be a 4-week follow up period for subjects not participating in the OLE study. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	ASN002	Daily dose of ASN002 for 12 weeks
DRUG	Placebo Oral Tablet	Placebo of ASN002 for 12 weeks

Timeline

• Start date: 2018-07-05
• Primary completion: 2019-07-22
• Completion: 2019-08-14
• First posted: 2018-05-22
• Last updated: 2023-07-03
• Results posted: 2022-11-15

Locations

47 sites across 3 countries: United States, Canada, Germany

Regulatory

• FDA-regulated drug study