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

NCT07467564

RecruitingN/A

Sponsor: Sanofi

Conditions: Atopic Dermatitis

Interventions: Dupilumab

Countries: Qatar, Saudi Arabia, United Arab Emirates

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 overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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 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.

Locations (7)

Doha, Qatar
Jeddah, Saudi Arabia
Jeddah, Saudi Arabia
Abu Dhabi, United Arab Emirates
Fujairah, United Arab Emirates
Ras al-Khaimah, United Arab Emirates
Sharjah city, United Arab Emirates