Eczema drug Dupilumab's skin gene secrets revealed in small study
NCT ID NCT03293030
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how the eczema drug dupilumab (Dupixent) affects immune cells and genes in the skin. Seventeen adults with moderate-to-severe eczema took the drug, and researchers measured changes in skin samples over 12 weeks. The goal was to understand the biological effects of dupilumab on eczema lesions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dupilumab (Dupixent)
- What this could lead to
- If successful, this could help explain how dupilumab works in the skin to improve eczema treatment.
- What could go wrong
- This was a very small study with only 17 people and no comparison group, so results may not apply to everyone.
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
-
17 people
The number who actually took part.
- Started
-
Oct 2018
- Finished
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Feb 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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
-
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 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: * Ability to provide written informed consent and comply with the protocol. * At least 18 years of age. * Diagnosis of chronic atopic dermatitis for at least 3 years prior to enrollment. * Subject is considered a candidate for phototherapy or systemic therapy * Eczema Area and Severity Index (EASI) score ≥ 12 * Investigator Global Assessment (IGA) ≥ 3 * 10% body surface area (BSA) or greater * Subject is unlikely to conceive due to male, post-menopausal, or using adequate contraceptive (barrier, hormonal, implant, or permanent sterilization methods). * Physical exam within clinically acceptable limits. Exclusion Criteria: * Subject is unable to provide written informed consent or comply with the protocol. * Subject is younger than 18 years of age. * Subject has had atopic dermatitis for less than 3 years prior to enrollment. * Subject with mild atopic dermatitis (EASI\<12 and IGA\<3) or is not a candidate for phototherapy or systemic treatments. * Subject with current, or a history of, severe atopic dermatitis well controlled on current therapy. * Serious known infection. * History of immunosuppression (including human immunodeficiency virus (HIV)) * History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. * Severe concomitant illnesses. * Having used immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) or phototherapy within 4 weeks before the baseline visit. * Treatment with topical corticosteroid or topical calcineurin inhibitor within 1 week before the baseline visit. * Treatment with any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer, or use of other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer. * Physical or laboratory exam not within clinically acceptable limits. * Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere with the evaluation of the subject's atopic dermatitis. * History of known or suspected intolerance to any of the ingredients of the investigational study product. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>10 mIU/mL).
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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
-
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118, United States
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Other studies related to the condition(s) this trial covers.
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