Overview
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
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 to a patient's potential participation in a clinical trial.
