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

Asana BioSciences

Status and phase: Terminated; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: ASN002

Study type: Interventional

Funder types: Industry

Identifiers

NCT03654755

ASN002AD-201-EXT

Details and patient eligibility

About

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

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study
• Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment according to the investigator's judgment.
• Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study.
• Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse
• Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
• Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
• Subject has a body mass index (BMI) ≤ 38 kg/m2.

Exclusion Criteria

• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject has clinically infected atopic dermatitis.
• A serious uncontrolled condition including hypertension, history of tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer
• Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
• Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
• Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 3 patient groups

ASN002 40 mg

Experimental group

Description:

ASN002 40 mg

Treatment:

Drug: ASN002

ASN002 60 mg

Experimental group

Description:

ASN002 60 mg

Treatment:

Drug: ASN002

ASN002 80 mg

Experimental group

Description:

ASN002 80 mg

Treatment:

Drug: ASN002