Eczema drug dupilumab may rewire itch signals in skin
NCT ID NCT04823130
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looked at how dupilumab, an injectable eczema drug, changes nerve fibers in the skin of 54 adults with moderate-to-severe atopic dermatitis and chronic itching. Researchers took skin biopsies to measure nerve density and branching before and after treatment. The goal was to understand the biological reasons behind the drug's itch-relieving effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab (injection)
- What this could lead to
- If successful, this could help explain how dupilumab reduces itching in eczema by affecting skin nerves, potentially guiding better treatments.
- What could go wrong
- This is a small, exploratory Phase 4 study focused on understanding mechanisms, not proving a cure. Results may not lead to new treatments directly.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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54 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Aug 2022
- 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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: For AD participants * Male or female of greater than or equal to (\>=)18 years of age inclusive, at the time of signing the informed consent form (ICF). * Diagnosed with moderate-to-severe chronic AD for at least 1 year before screening. * Eligible to be treated with dupilumab according to product monograph. * Pruritus lasting 6 or more weeks before baseline (Day 1). * Eczema Area and Severity Index (EASI) score \>=12 at baseline. * Pruritus numerical rating scale (NRS) \>=4 at baseline. * Investigator global assessment (IGA) score of \>=3 at screening (on the 0 to 4 scale) at baseline. * Atopic dermatitis active lesions on the upper limbs or lower limbs suitable for a skin biopsy without oozing, bleeding, or infection on upper limbs or trunk. * Participants with acute AD lesions as determined by Investigator's judgment. * Stable treatment with non-prohibited medication or therapy during the study. For Healthy participants * Male or female of \>=18 years of age inclusive, at the time of signing the ICF. * Certified as generally healthy by a comprehensive clinical assessment. Exclusion criteria: For AD participants * Previous treatment with dupilumab stopped within 6 months of baseline due to inadequate response to dupilumab. * Skin conditions other than AD that can confound assessments in the opinion of the investigator. * Regular use (\>2 visits per week) of a tanning booth/parlor within 4 weeks of the Screening Visit. * Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. * Participants with active tuberculosis (TB) or non-TB mycobacterial infection, or a history of incompletely treated TB unless it is well documented the participant has been adequately treated and can now start treatment with a biologic agent * Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the Screening Visit (Visit 1) or during the Screening Period. * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the Screening Visit (Visit 1) or during the Screening Period. * Known or suspected immunodeficiency, including history of invasive opportunistic infections. * Active malignancy or history of malignancy within 5 years before the Baseline Visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. * Ocular disorder that in the opinion of the Investigator could adversely affect the individual's risk for study participation. Examples include, but are not limited to, individuals with a history of active cases of herpes keratitis, Sjogren's syndrome, keratoconjunctivitis sicca or dry eye syndrome that require daily use of supplemental lubrication or individuals with ocular conditions that require the use of ocular corticosteroids or cyclosporine. * History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy, including any excipient. * Participant with any other medical or psychological condition including relevant laboratory or electrocardiogram abnormalities at screening. For healthy participants * Regular use (\>2 visits per week) of a tanning booth/ parlor within 4 weeks of the Screening Visit. * Treatment with the following concomitant medications and procedures is prohibited within 4 weeks before the Screening Visit or 5 half-lives (whichever is longer) until End of Study Visit: * Topical medication * Analgesics * Immunomodulators * Antidepressants * Anti-anxiety drugs * Any Type 2 immune disorders uncontrolled Type 2 diabetes mellitus, Type 1 diabetes mellitus, neuropathy or any other neurological disease. * Any concomitant illness(es) or conditions that, in the Investigator's judgment, would adversely affect the participant's participation in the study or potentially affect any skin biopsy related read out. * Positive test for immunoglobulin E (IgE) antibodies. 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Investigational Site Number 2760001
Münster, 48149, Germany
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Investigational Site Number 8400001
Miami, Florida, 33136, United States
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Investigational Site Number 8400002
East Windsor, New Jersey, 08520, United States
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