Dupilumab's effect on anxiety and depression in moderate-to-severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Investigational Site: Saudi Medical Services (Medical Fakeeh)
  Jeddah, Saudi Arabia Recruiting
• Investigational Site: NMC Specialty Hospital LTD
  Abu Dhabi, United Arab Emirates Recruiting
• Investigational Site: Dibba Hospital
  Fujairah, United Arab Emirates Recruiting
• Investigational Site: Ibrahem Bin Hamad Hospital
  Ras al-Khaimah, United Arab Emirates Recruiting
• Investigational Site: Hamad Medical Corporation
  Doha, Qatar Active not recruiting
• Investigational Site: King Faisal Specialist Hospital
  Jeddah, Saudi Arabia Active not recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• See if IBI3027 works as well as Dupilumab for moderate to severe atopic dermatitis

  This study tests whether IBI3027 can help people with moderate to severe atopic dermatitis as effectively as Dupilumab injections.

  Recruiting Phase 3 Innovent Biologics (Suzhou) Co. Ltd. · Guangzhou, Guangdong · NCT07754786

• Observing how adolescents with severe atopic dermatitis respond to dupilumab treatment

  This study looks at how well dupilumab treatment works for teenagers aged 12 to 17 with severe eczema over a year, focusing on their symptoms and quality of life.

  Recruiting at 9 sites Sanofi · Bologna and 8 other locations · NCT06192563

• Virtual reality game to reduce pain and anxiety during dupilumab injections

  This project will test whether a virtual reality game can reduce pain and anxiety for children aged 6–17 during dupilumab injections for moderate to severe atopic dermatitis.

  Recruiting at 2 sites St. Justine's Hospital · Montreal, Quebec and 1 other locations · NCT06182436

• Examining how dupilumab affects immune cells in atopic dermatitis

  This study is testing how the medication dupilumab affects immune cells in the skin of people with moderate to severe atopic dermatitis.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT05858619

• Using Dupixent and UVB therapy for treating atopic dermatitis

  This study is testing if combining a medication called Dupixent with UVB light therapy can help people with moderate to severe eczema feel better.

  Recruiting Phase 4 Psoriasis Treatment Center of Central New Jersey · East Windsor, New Jersey · NCT05285839

• Exploring how dupilumab works differently in various ethnic groups with atopic dermatitis

  This study is testing how well dupilumab works for people with atopic dermatitis from different ethnic backgrounds, like Caucasian, Asian, and African American, to see if their responses vary.

  Recruiting Phase 4 University of Michigan · Ann Arbor, Michigan · NCT05268107

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.