RecruitingNCT07467564

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

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


Sponsor

Sanofi

Enrollment

184 participants

Start Date

Feb 24, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 12 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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.

Interventions

DRUGDupilumab

This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.


Locations(1)

NMC Specialty Hospital LTD

Abu Dhabi, United Arab Emirates

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NCT07467564


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