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Eczema drug dupilumab may rewire itch signals in skin

NCT ID NCT04823130

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 4

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

Participants

54 people

The number who actually took part.

Started

Apr 2021

Finished

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 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

  • Investigational Site Number 2760001

    Münster, 48149, Germany

  • Investigational Site Number 8400001

    Miami, Florida, 33136, United States

  • Investigational Site Number 8400002

    East Windsor, New Jersey, 08520, United States

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