Recruiting
Phase 3

Upadacitinib vs. Dupilumab

Sponsor:

AbbVie

Code:

NCT06461897

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

Interventions

Upadacitinib

Dupilumab

Study Details

Brief summary:

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed.

Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement.

Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by clinical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

Atopic Dermatitis

Study ID

NCT06461897

Start date

Aug 19, 2024

Status verified date

Aug, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

675 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dupi-IR Cohort

Participants in this cohort will receive upadacitinib medium dose.

experimental: Randomized Cohort

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).

Interventions

Upadacitinib

Oral Tablet or Oral Solution

Dupilumab

Subcutaneous Injection

Primary outcome measure

  • Percentage of Participants Achieving a 75% Reduction from Baseline in Eczema Area and Severity Index 75 (EASI 75) Score (other than US) [ Time Frame: At Week 16 ]
  • Percentage of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0 or 1 with a reduction from Baseline of ≥ 2 points (US and China only, descriptive) [ Time Frame: Week 16 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately Week 172 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Applied Research Center and Wellness Clinic /ID# 268547

Recruiting

Little Rock, Arkansas, United States, 72205

Stanford University School of Medicine /ID# 269622

Recruiting

Palo Alto, California, United States, 94304

Contacts

Site Coordinator

650-725-9600chong@stanfordchildrens.org

Integrative Skin Science and Research /ID# 265108

Recruiting

Sacramento, California, United States, 95815

Pediatric Skin Research - Coral Gables /ID# 266308

Recruiting

Coral Gables, Florida, United States, 33146

Emory University School Of Medicine - Atlanta /ID# 268832

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Coordinator

404-785-5719hagar.wilkinson@choa.org

Aeroallergy Research Laboratory /ID# 267247

Recruiting

Savannah, Georgia, United States, 31406

Treasure Valley Medical Research /ID# 266838

Recruiting

Boise, Idaho, United States, 83706

Northwestern University Feinberg School of Medicine /ID# 265117

Recruiting

Chicago, Illinois, United States, 60611-2927

Sneeze Wheeze & Itch Associates /ID# 267238

Recruiting

Normal, Illinois, United States, 61761

Dawes Fretzin /ID# 265097

Recruiting

Indianapolis, Indiana, United States, 46256

Equity Medical, LLC /ID# 268270

Recruiting

Bowling Green, Kentucky, United States, 42104

Maryland Allergy & Asthma Center /ID# 268032

Recruiting

Lanham, Maryland, United States, 20706

Washington University School of Medicine - St. Louis /ID# 268545

Recruiting

St Louis, Missouri, United States, 63130

Skin Specialists /ID# 266331

Recruiting

Omaha, Nebraska, United States, 68144

Contacts

Site Coordinator

402-697-6599

DOCS Clinical Research - Canal Winchester /ID# 268271

Recruiting

Canal Winchester, Ohio, United States, 43110-2069

Wright State Physicians Health Center /ID# 268841

Recruiting

Fairborn, Ohio, United States, 45324

Contacts

Site Coordinator

9372457500

Oregon Health and Science University /ID# 266483

Recruiting

Portland, Oregon, United States, 97239

Medical University of South Carolina /ID# 265113

Recruiting

Charleston, South Carolina, United States, 29425

Arlington Research Center, Inc /ID# 266330

Recruiting

Arlington, Texas, United States, 76011

3A Research - East location /ID# 267622

Recruiting

El Paso, Texas, United States, 79925

Prime Clinical Research - Mansfield - East Broad Street /ID# 268042

Recruiting

Mansfield, Texas, United States, 76063

Texas Dermatology and Laser Specialists /ID# 267249

Recruiting

San Antonio, Texas, United States, 78218

Contacts

Site Coordinator

210-852-2779

Progressive Clinical Research - San Antonio /ID# 267262

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Site Coordinator

210-614-5557

Jordan Valley Dermatology & Research Center /ID# 267092

Recruiting

South Jordan, Utah, United States, 84095

West Virginia University Hospitals /ID# 265114

Recruiting

Morgantown, West Virginia, United States, 26506

Medical College Of Wisconsin - Milwaukee Campus /ID# 267236

Recruiting

Milwaukee, Wisconsin, United States, 53226

Dermatology Research Institute - Blackfoot Trail /ID# 266744

Recruiting

Calgary, Alberta, Canada, T2J 7E1

Rejuvenation Dermatology - Edmonton Downtown /ID# 267871

Recruiting

Edmonton, Alberta, Canada, T5J 3S9

British Columbia Children and Women's Hospital and Health Centre /ID# 265395

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Leader Research /ID# 266745

Recruiting

Hamilton, Ontario, Canada, L8L 3C3

Triple A Lab Inc /ID# 266615

Recruiting

Hamilton, Ontario, Canada, L8S 1G5

Lynderm Research Inc /ID# 267006

Recruiting

Markham, Ontario, Canada, L3P 1X2

Allergy Research Canada /ID# 270230

Recruiting

Niagara Falls, Ontario, Canada, L2H 1H5

Centre Hospitalier Universitaire (CHU) Sainte-Justine /ID# 266831

Recruiting

Montreal, Quebec, Canada, H3T 1C5

More Information

Sponsor

AbbVie

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Atopic Dermatitis
  • Upadacitinib
  • RINVOQ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-06.