Dupilumab's effect on anxiety and depression in 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

This project will see if dupilumab reduces anxiety and depression in people with moderate-to-severe atopic dermatitis who are starting or recently started the medicine.

Quick facts

• Study type: Observational
• Enrollment: 184 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Sanofi (industry)
• Drugs / interventions: dupilumab
• Locations: 1 site (Abu Dhabi)
• Trial ID: NCT07467564 on ClinicalTrials.gov

What this trial studies

This is an observational, single-site study enrolling people with moderate-to-severe atopic dermatitis who have symptoms of anxiety or depression and who are initiating or recently initiated dupilumab. Participants will be followed for six months after enrollment, with an overall enrollment period of about nine months. The study will collect measures of mental health and quality of life alongside routine clinical data to describe changes over time while on dupilumab. Patients with recent antidepressant/anti-anxiety medication use, active infections, certain chronic illnesses, pregnancy, or concurrent trial participation are excluded.

Who should consider this trial

Good fit: Ideal candidates are people with moderate-to-severe atopic dermatitis who have signs of anxiety or depression and who are starting dupilumab within 30 days or are already receiving it.

Not a fit: People who are pregnant or lactating, recently on antidepressant or anti-anxiety drugs, have active infections, HIV/hepatitis/malignancy, or are enrolled in other trials are excluded and may not receive benefit from this study.

Why it matters

Potential benefit: If successful, the study could show that dupilumab improves anxiety and depression symptoms and overall quality of life for patients with moderate-to-severe atopic dermatitis.

How similar studies have performed: Prior reports and observational studies have reported improvements in quality of life and reductions in anxiety/depression with dupilumab, although focused mental-health data remain limited.

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.

Where this trial is running

Abu Dhabi

• NMC Specialty Hospital LTD — Abu Dhabi, United Arab Emirates (RECRUITING)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions: Atopic Dermatitis