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Comparing Upadacitinib and Dupilumab for Treating Atopic Dermatitis in Young Children

A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis

PHASE3 · AbbVie · NCT06461897

This study is testing whether a new medication called upadacitinib works better than dupilumab for treating moderate to severe eczema in young children aged 2 to under 12.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment675 (estimated)
Ages2 Years to 11 Years
SexAll
SponsorAbbVie (industry)
Drugs / interventionsdupilumab, methotrexate, upadacitinib
Locations148 sites (Little Rock, Arkansas and 147 other locations)
Trial IDNCT06461897 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of upadacitinib compared to dupilumab in children aged 2 to less than 12 years with moderate to severe atopic dermatitis. Participants will receive either daily doses of upadacitinib or dupilumab administered every 2 to 4 weeks, depending on randomization. The study aims to assess adverse events and changes in disease activity, with approximately 675 participants enrolled across 150 sites worldwide. Participants will be stratified based on disease severity, age, and previous treatment responses.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to less than 12 years with moderate to severe atopic dermatitis who require systemic therapy.

Not a fit: Patients with mild atopic dermatitis or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for young children suffering from moderate to severe atopic dermatitis.

How similar studies have performed: Other studies have shown success with similar approaches in treating atopic dermatitis, indicating a promising avenue for this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* A minimum weight of 10 kg and weight and height \> 5th percentile for their age according to local standard growth charts at the Baseline Visit.
* Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline.
* Eczema Area and Severity Index (EASI) score \>= 16; vIGA-AD score \>= 3 (Note: In countries where dupilumab is only approved for severe AD, subjects to be included in the Randomized Cohort should have severe AD \[vIGA-AD = 4\]); \>= 10% Body Surface Area of AD involvement at the Baseline Visit; and Baseline weekly average of daily Worst Itch Scale (WIS) or Worst Scratch/Itch numerical rating scale (WSI-NRS) \>= 4.
* Participant must satisfy at least one of the following criteria (Note: More than 1 criterion may apply to an individual participant. All applicable criteria for each individual participant should be reported):
* To be included in the Randomized Cohort (Note: Participants must have severe AD \[vIGA-AD = 4\] in countries where dupilumab is approved only for severe AD.):

  1. \[For all countries except US\] Documented history of inadequate response or intolerance to TCS and/or TCI OR for whom use of one or more of these topical treatments is medically inadvisable (e.g., high disease burden, Scoring Atopic Dermatitis (SCORAD) \> 50, EASI score \> 21, or vIGA-AD \> 3).
  2. For dupilumab-naïve participants: History of inadequate response to a systemic therapy for AD other than dupilumab or oral corticosteroids or for whom the available systemic treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
  3. History of inadequate response to 2 or more courses of oral corticosteroid therapy given for \>= 14 days within 6 months prior to Screening or history of oral corticosteroid rebound, defined as recurrence of AD symptoms within 4 months after its discontinuation.
  4. For dupilumab-exposed participants: Prior exposure to dupilumab without documented history of inadequate response or intolerance (i.e., discontinuation of dupilumab for a non-medical reason, such as, but not limited to, non-coverage or loss of coverage for the drug by health insurance, or other logistic challenges \[not safety- or efficacy-related\] precluding the participants continued access to dupilumab).
* To be included in the Dupi-IR/Dupi-Medically Inadvisable Cohort:

  * Previous inadequate response or intolerance to dupilumab OR
  * Dupilumab is medically inadvisable (e.g., allergy to a component of dupilumab, etc.) AND a documented history of inadequate response or intolerance to TCS and/or TCI.

Exclusion Criteria:

* Current or past history of other active skin diseases (e.g., psoriasis or Netherton syndrome or lupus erythematosus) or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or which would interfere with the appropriate assessment of AD lesions.
* Have used topical treatments for AD (except for topical emollient treatments) including but not limited to TCS, TCI, or topical phosphodiesterase type 4 (PDE-4) inhibitors, within 7 days of the Baseline Visit or any the following prohibited concomitant AD treatments within the specified timeframes below prior to the Baseline Visit:

  * Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, PDE-4 inhibitors, interferon-γ, and mycophenolate mofetil within 4 weeks;
  * Dupilumab within 8 weeks;
  * Targeted biologic treatments (other than dupilumab) within 5 half-lives (if known) or within 12 weeks, whichever is longer;
  * Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
* Known history of retinal detachment, previous cataract surgery, previous significant ocular trauma, or a known congenital ocular abnormality.
* For Randomized Cohort: diagnosed active parasitic infection; suspected or high risk of parasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.

Where this trial is running

Little Rock, Arkansas and 147 other locations

+98 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Atopic Dermatitis, Upadacitinib, RINVOQ

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.