Recruiting

Start UpUpadacitinib vs Dupilumab for Pediatric Atopic Dermatitis

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Study Aim

This study aims to evaluate the effectiveness and safety of Upadacitinib compared to Dupilumab in children with atopic dermatitis, focusing on reducing eczema severity and monitoring any adverse effects.

What is being tested

Upadacitinib

+ Dupilumab

Drug
Who is being recruted

Dermatitis+8

+ Dermatitis, Atopic

+ Hypersensitivity

From 2 to 11 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 19, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding better treatments for children aged 2 to less than 12 years who have moderate to severe atopic dermatitis, a skin condition that causes itching and rashes. The study aims to compare the effectiveness and safety of two medicines, upadacitinib and dupilumab, to see which one works better for systemic treatment when skin-applied therapies are not enough. By comparing these treatments, the study hopes to find more effective ways to manage this challenging skin condition in young children. The trial involves approximately 675 children worldwide who will either take upadacitinib daily in the form of a tablet or an oral solution for about three years, or receive dupilumab every 2 or 4 weeks for one year. Participants will be observed over this period through regular visits to a hospital or clinic, where doctors will perform check-ups, blood tests, and gather information from questionnaires to monitor the treatment's effects and any side effects. There is a 1 in 5 chance for participants to receive dupilumab. This research may involve more effort than usual care, but it is essential for evaluating how each treatment impacts the condition.

Official TitleA 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
NCT06461897
Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

675 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 11 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, Inborn

Criteria

10 inclusion criteria required to participate
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.):
[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).
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).
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.
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8 exclusion criteria prevent from participating
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;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this cohort will receive upadacitinib medium dose.

Group II

Experimental
Participants in the Randomized Cohort will be randomized to receive either medium dose upadacitinib daily adult equivalent dose, low dose upadacitinib daily adult equivalent dose or dupilumab every 2 weeks or 4 weeks (at the label-indicated dose and frequency).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 148 locations

Recruiting

Applied Research Center Of Arkansas /ID# 268547

Little Rock, United StatesOpen Applied Research Center Of Arkansas /ID# 268547 in Google Maps
Recruiting

Stanford University School of Medicine - Palo Alto /ID# 269622

Palo Alto, United States
Recruiting

Integrative Skin Science and Research /ID# 265108

Sacramento, United States
Recruiting

Pediatric Skin Research /ID# 266308

Coral Gables, United States
Recruiting
148 Study Centers