Atopic Dermatitis study: Dupilumab
Official title Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT05042258
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, being studied as a potential treatment for atopic dermatitis.
Also referred to as Dupixent.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to learn whether dupilumab can improve sleep quality, reduce itching, and normalize circadian (body‑clock) function after 12 weeks of treatment.
- Who it's for
- Children ages 6 to 17 who have moderate or severe atopic dermatitis (eczema).
- What's involved
- Participants will receive dupilumab, an injectable medication, for 12 weeks and will have assessments of sleep, itching and circadian function during the study.
- Time commitment
- The trial lasts about 12 weeks and includes a few clinic visits for treatment and testing.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Participants, 6-17 years old at time of enrollment.
- Moderate to severe chronic AD inadequately controlled by topical treatment, diagnosed according to Hanifin and Rajka criteria by a pediatric...
- AD severity will be determined at baseline with Validated Investigator Global Assessment (vIGA) score of moderate (3) or severe (4).
- Patient assessed or parent-proxy (under 8 years old) PROMIS sleep disturbance T-score ≥60.
- Willing and able to comply with visits and study-related procedures.
You likely can't join if
- Poorly controlled asthma (Asthma Control Test ≤19).
- Self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis.
- Use of concomitant medication that causes scratching.
- Major medical condition (such as cancer).
- Active condition that could affect sleep, such as obstructive sleep apnea, restless leg syndrome, insomnia, narcolepsy, severe sleep disordered...
- Having applied topical steroids within 7 days of first or second PSG (important for biomarkers assessment).
See the full eligibility criteria
- Participants, 6-17 years old at time of enrollment.
- Moderate to severe chronic AD inadequately controlled by topical treatment, diagnosed according to Hanifin and Rajka criteria by a pediatric dermatologist or allergist.
- AD severity will be determined at baseline with Validated Investigator Global Assessment (vIGA) score of moderate (3) or severe (4).
- Patient assessed or parent-proxy (under 8 years old) PROMIS sleep disturbance T-score ≥60.
- Willing and able to comply with visits and study-related procedures.
- On stable regimens (consistent use 14 days before Day 1 of study enrollment) of inhaled corticosteroids, topical steroids, and antihistamines.
- Poorly controlled asthma (Asthma Control Test ≤19).
- Self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis.
- Use of concomitant medication that causes scratching.
- Major medical condition (such as cancer).
- Active condition that could affect sleep, such as obstructive sleep apnea, restless leg syndrome, insomnia, narcolepsy, severe sleep disordered breathing, severe depression, COVID-19, or hives (urticaria).
- Having applied topical steroids within 7 days of first or second PSG (important for biomarkers assessment).
- Use of systemic immunosuppressant within 30 days of first PSG.
- Having showered or used moisturizers within 12 hours of first or second PSG.
- Unable to communicate in English (some PROMIS questionnaires not available in translation).
- Other contraindication to receiving dupilumab (such as history of allergic reaction to dupilumab or any of its components).
- Pregnancy.
- Clinical blindness (circadian disturbing).
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.