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Eczema drug dupilumab shows promise for better sleep

NCT ID NCT04033367

Symptom relief Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether dupilumab, an injectable drug that reduces inflammation, can improve sleep quality in adults with moderate-to-severe atopic dermatitis (eczema). 188 participants received either dupilumab or a placebo. The main goal was to measure changes in sleep quality over 12 weeks. The trial is already completed, so results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dupilumab (an injectable biologic drug that blocks inflammation)
What this could lead to
If successful, this could confirm that dupilumab helps people with eczema sleep better, improving their daily life.
What could go wrong
This is a completed Phase 4 trial, so results are already known. It only tested sleep effects, not a cure, and benefits may not apply to everyone with eczema.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

188 people

The number who actually took part.

Started

Aug 2019

Finished

Oct 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: Participants, male or female 18 years or older, * with diagnosed chronic AD, demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance. * had applied skin emollients (moisturizers) at least 7 days before screening. * had applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before screening. * willed and able to comply with all clinic visits and study-related procedures. * provided signed informed consent. Exclusion criteria: Participants excluded from the study: * with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that might present unreasonable risk to participants or interfered with study assessment, or any severe concomitant illness(es) that would adversely affect the participant's participation in the study, and contraindications of topical corticosteroids. * at Baseline, presence of any conditions listed as criteria for study drug discontinuation. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • Investigational Site Number :0360001

    Kogarah, New South Wales, 2217, Australia

  • Investigational Site Number :0360003

    Carlton, Victoria, 3053, Australia

  • Investigational Site Number :0360006

    Phillip, Australian Capital Territory, 2606, Australia

  • Investigational Site Number :0360007

    Woolloongabba, Queensland, 4102, Australia

  • Investigational Site Number :2500001

    Brest, 29200, France

  • Investigational Site Number :2500002

    Paris, 75014, France

  • Investigational Site Number :2500003

    Nantes, 44093, France

  • Investigational Site Number :2500006

    Toulouse, 31059, France

  • Investigational Site Number :2760001

    Göttingen, 37075, Germany

  • Investigational Site Number :2760002

    Frankfurt am Main, 60590, Germany

  • Investigational Site Number :2760004

    Münster, 48149, Germany

  • Investigational Site Number :2760005

    Bad Bentheim, 48455, Germany

  • Investigational Site Number :2760006

    Friedrichshafen, 88045, Germany

  • Investigational Site Number :3760003

    Jerusalem, 91120, Israel

  • Investigational Site Number :3760005

    Afula, 18101, Israel

  • Investigational Site Number :3800001

    Pisa, 56126, Italy

  • Investigational Site Number :3800002

    Roma, 168, Italy

  • Investigational Site Number :3800003

    Siena, 53100, Italy

  • Investigational Site Number :3800004

    Reggio Calabria, 86100, Italy

  • Investigational Site Number :3800005

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number :3800006

    Perugia, 06129, Italy

  • Investigational Site Number :7240001

    Barcelona / Sabadell, Castille and León, 08208, Spain

  • Investigational Site Number :7240002

    Valencia, 46026, Spain

  • Investigational Site Number :7240003

    Manises, Valencia, 46940, Spain

  • Investigational Site Number :7240004

    Granada, Andalusia, 18016, Spain

  • Investigational Site Number :7240005

    Seville, 41013, Spain

  • Investigational Site Number :7240006

    Córdoba, 14004, Spain

  • Investigational Site Number :7240008

    Madrid, 28007, Spain

  • Investigational Site Number :7240010

    Madrid, 28922, Spain

  • Investigational Site Number :7560001

    Bern, 3010, Switzerland

  • Investigational Site Number :7840001

    Dubai, United Arab Emirates

  • Investigational Site Number :7840002

    Abu Dhabi, 46713, United Arab Emirates

  • Investigational Site Number :8260002

    Dudley, Birmingham, DY1 2HQ, United Kingdom

  • Investigational Site Number :8260004

    Edinburgh, Edinburgh, City of, EH16 4SA, United Kingdom

  • Investigational Site Number :8400001

    Rolling Hills Estates, California, 90274, United States

  • Investigational Site Number :8400002

    Redwood City, California, 94063, United States

  • Investigational Site Number :8400003

    Sarasota, Florida, 34239, United States

  • Investigational Site Number :8400005

    Denver, Colorado, 80230, United States

  • Investigational Site Number :8400007

    Medford, Oregon, 97504, United States

  • Investigational Site Number :8400008

    Charleston, South Carolina, 29407, United States

  • Investigational Site Number :8400012

    North Little Rock, Arkansas, 72117, United States

  • Investigational Site Number :8400013

    Colorado Springs, Colorado, 80907, United States

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