The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Ability to provide written informed consent and comply with the protocol

• At least 18 years of age

• Diagnosis of atopic dermatitis at least 6 months prior to enrollment, having stable (unchanged) disease for at least 2 months

• Non-immune-compromised status

• Subjects have moderate-to-severe atopic dermatitis, classified as Eczema Area and Severity Index (EASI) score greater than or equal to 6

• Subject is considered a candidate for phototherapy or systemic therapy

• Subjects of child-bearing potential must have a negative urine pregnancy test within 7 days prior to first dose of dupilumab

• Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study

• Subject meets concomitant medication requirements (see below)

Exclusion Criteria:

• Younger than 18 years of age

• Has mild atopic dermatitis, classified as EASI score less than 6

• History of known or suspected intolerance to any of the ingredients of the investigational study product

• Evidence of skin conditions other than atopic dermatitis that would interfere with study-related evaluations of atopic dermatitis.

• History of immune-compromised status [e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug] or a congenital or acquired immunodeficiency or subject testing positive for HIV during screening procedures

• Has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk

• Has a history of or ongoing drug or alcohol abuse

• Is not willing to comply with concomitant medication requirements

• Is known, or suspected of being unable to comply with the study protocol

• Subjects who are well controlled on current treatment for atopic dermatitis and participation in the study may worsen disease control significantly