A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis

Phase 1

Completed

• Conditions: Dermatitis, Atopic; Dermatitis Eczema; Dermatitis, Eczematous
• Interventions: Drug: ASN002; Drug: Placebo Oral Tablet

• Registration Number: NCT03139981
• Lead Sponsor: Asana BioSciences

Brief 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.

Study Timeline

• Study Start: 2017-04-12
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Primary Completion: 2017-11-05
• Status Verified: 2017-12
• Study Completion: 2017-12-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASN002 120 mg	ASN002	120 mg ASN002
ASN002 120 mg	Placebo Oral Tablet	120 mg ASN002
ASN002 40 mg	ASN002	40 mg ASN002
ASN002 40 mg	Placebo Oral Tablet	40 mg ASN002
ASN002 80 mg	ASN002	80 mg ASN002
ASN002 20 mg	Placebo Oral Tablet	20 mg ASN002
ASN002 80 mg	Placebo Oral Tablet	80 mg ASN002
ASN002 20 mg	ASN002	20 mg ASN002

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose of ASN002	43 days	Analyze the number and type of adverse events reported.

Secondary Outcome Measures

Name	Time	Method
Calculate the area under the plasma concentration versus time curve	16 Days	A plot of the concentrations of ASN002 in blood plasma over time.
Calculate the Pharmacokinetic Half-life	16 Days	The time required for ASN002 concentration to decrease by 50%
Change from baseline in the subject-reported puritis (itch) score	28 days	Rating of puritis based degree, duration, direction, disability, and distribution
Change from baseline in EASI score	28 days	Measurement of area and severity of atopic dermatitis
Calculate the Pharmacokinetic maximum concentration	16 Days	Maximum concentration of ASN002 achieved after dosing.
Change from baseline in the Investigator Global Assessment	28 days	determine overall severity of atopic dermatitis

Trial Locations

Locations (10)

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

TCR Medical Corporation; 🇺🇸 San Diego, California, United States

Olympian Clinical Research; 🇺🇸 Tampa, Florida, United States

Progressive Clinical Research, P.A.; 🇺🇸 San Antonio, Texas, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

Dermatology Specialists Research; 🇺🇸 Louisville, Kentucky, United States

Innovaderm Research; 🇨🇦 Montréal, Canada

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Center for Clinical Studies, Ltd., LLP; 🇺🇸 Houston, Texas, United States

Forward Clinical Trials, Inc.; 🇺🇸 Tampa, Florida, United States