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

  • STATUS
    Recruiting
  • End date
    May 24, 2027
  • participants needed
    184
  • sponsor
    Sanofi
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Updated on 23 April 2026
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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.

Details
Condition Atopic Dermatitis
Age 12years or above
Clinical Study IdentifierNCT07467564
SponsorSanofi
Last Modified on23 April 2026

Eligibility

 Yes No Not Sure

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 those who are planning to receive antidepressants/anti-anxiety. In addition, those who will use antidepressants/anti-anxiety medications throughout the study will be excluded from the analysis
The above information is not intended to contain all considerations relevant
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