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

• Status: Terminated
• Trial end date: 2019-09-09
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asana BioSciences

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 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 must be a candidate for prolonged open label ASN002 treatment according to the investigator's judgment.

• Subject has a body mass index (BMI) ≤ 35 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.