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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorSanofi

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dupilumab

Treatment groups

No treatment groups listed

Sponsors and collaborators

Sanofi

Lead sponsor

Regeneron Pharmaceuticals

Collaborator