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Recruiting NCT07467564

The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis

Trial Parameters

Condition Atopic Dermatitis
Sponsor Sanofi
Study Type OBSERVATIONAL
Phase N/A
Enrollment 184
Sex ALL
Min Age 12 Years
Max Age N/A
Start Date 2026-02-24
Completion 2027-05-24
Interventions
Dupilumab

Brief Summary

This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.

Eligibility Criteria

Inclusion Criteria: * Participants who have moderate to severe AD with signs and symptoms of anxiety and/or depression. * Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation * Participants and/or their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent. Exclusion Criteria: * Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months. * Participants who are participating in another trial. * Participants with active chronic or acute infection requiring systemic treatment. * Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection. * Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses. * Participants on antidepressants/anti-anxiety within 6 months of enrolment or

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