Phase 4
Completed N=17
Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis
Atopic Dermatitis · Atopic Dermatitis Eczema · Atopic Dermatitis and Related Conditions
Source: ClinicalTrials.gov NCT03293030 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Percent Change in CD4+ T Effector Cells Expressing IL4 in Dupilumab-treated Subjects at Week 12 vs Week 0 — 68.4; 100.0 Percent change
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a single-arm, open-label study to examine the effect of dupilumab on the immunologic and genetic environment within atopic dermatitis skin lesions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in CD4+ T Effector Cells Expressing IL4 in Dupilumab-treated Subjects at Week 12 vs Week 0 |
68.4; 100.0 | — |
| SECONDARY Number of Differentially Expressed Genes in Cutaneous CD4+ T Cells Between Week 0 and Week 12 in Dupilumab-treated Subjects |
81; 186 | <0.05 sig |
Eligibility Criteria
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 10 mIU/mL).
Data sourced from ClinicalTrials.gov (NCT03293030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.