Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04033367) looked at the use of dupilumab (an injectable medicine) in people with atopic dermatitis (eczema) who also had problems with sleep. A total of 188 participants took part — 127 received dupilumab from the start, and 61 received a placebo (an inactive dummy treatment). The trial had two phases: a 12-week "double-blind" period (where neither participants nor researchers knew who was getting which treatment), followed by a 12-week open-label extension where everyone received dupilumab. The main thing being measured was how much participants' sleep quality scores changed over the first 12 weeks. The reported data shows that, for the main measure — sleep quality rated on a scale of 0 (worst) to 10 (best) — the dupilumab group reported an average decrease of about 47.7% from their starting score, compared to a decrease of about 33.0% in the placebo group. For itch intensity (rated 0–10, with 10 being worst), the dupilumab group reported an average reduction of around 52.5%, compared to around 23.3% in the placebo group. The reported data also shows changes in an overall eczema severity score (called SCORAD, ranging 0–103): the dupilumab group showed an average decrease of about 37.8 points, compared to about 20.6 points in the placebo group. For the other reported measures, the dupilumab group showed an average reduction of 4.85 points in a sleep-loss rating (on a 0–10 scale), compared to 2.31 points in the placebo group. On a standardised sleep impairment questionnaire (where lower scores mean less impairment), the dupilumab group's score fell by an average of 11.42 points, compared to 7.77 points in the placebo group. Finally, for total nightly sleep time, the dupilumab group reported sleeping on average 9 minutes more per night by week 12, while the placebo group reported sleeping about 6.4 minutes less. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Sleep Disorders Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are a man or woman aged 18 or older who has been diagnosed with long-term (chronic) atopic dermatitis (eczema)
- Your eczema has not been well controlled with creams or ointments applied to the skin
- Your eczema is considered to be of a certain level of severity, and it is affecting your sleep (confirm with trial site)
- You have been regularly using moisturizers on your skin for at least 7 days before your first study appointment
- You have been applying a medium-strength steroid cream to all active eczema patches for at least 7 days before your first study appointment
- You are willing and able to attend all clinic visits and follow all study procedures
- You are willing to sign a consent form agreeing to take part in the study
Who may not be able to join:
- You have a known allergy or sensitivity to the drug Dupixent (dupilumab)
- You have been diagnosed with clinical depression
- You have a history of drug abuse
- You have sleep problems that are not caused by your eczema
- You have an irregular sleep schedule
- You currently have an active or sudden (acute) infection
- You have serious or severe medical conditions or significant abnormal laboratory test results
- You have any other serious illness that could affect your ability to take part safely
- You have any reason that steroid creams should not be used on your skin
- At the start of the study, you meet any conditions that would require the study medication to be stopped (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Sciences & Operations, Sanofi
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.