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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 2 Years and 11 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dupi-IR Cohort 		Participants in this cohort will receive upadacitinib medium dose.
  • Drug: Upadacitinib
    Oral Tablet or Oral Solution
    Other names:
    • ABT-494
    • RINVOQ®
    • RINVOQ LQ
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).
  • Drug: Upadacitinib
    Oral Tablet or Oral Solution
    Other names:
    • ABT-494
    • RINVOQ®
    • RINVOQ LQ
  • Drug: Dupilumab
    Subcutaneous Injection

Recruiting Locations

Applied Research Center Of Arkansas /ID# 268547
Little Rock 4119403, Arkansas 4099753 72205

Integrative Skin Science and Research /ID# 265108
Sacramento 5389489, California 5332921 95815

Pediatric Skin Research /ID# 266308
Coral Gables 4151871, Florida 4155751 33146

Aeroallergy Research Laboratory /ID# 267247
Savannah 4221552, Georgia 4197000 31406

Treasure Valley Medical Research /ID# 266838
Boise 5586437, Idaho 5596512 83706

Northwestern University Feinberg School of Medicine /ID# 265117
Chicago 4887398, Illinois 4896861 60611-2927

Sneeze Wheeze & Itch Associates /ID# 267238
Normal 4903780, Illinois 4896861 61761

Dawes Fretzin, LLC /ID# 265097
Indianapolis 4259418, Indiana 4921868 46256

Equity Medical, LLC /ID# 268270
Bowling Green 4285268, Kentucky 6254925 42104

Maryland Allergy & Asthma Center /ID# 268032
Lanham 4360321, Maryland 4361885 20706

DermAssociates - Rockville /ID# 266457
Rockville 4367175, Maryland 4361885 20850

Washington University School of Medicine - St. Louis /ID# 268545
St Louis 4407066, Missouri 4398678 63130

Skin Specialists /ID# 266331
Omaha 5074472, Nebraska 5073708 68144
Contact:
Site Coordinator
402-697-6599

DOCS Clinical Research - Canal Winchester /ID# 268271
Canal Winchester 4507883, Ohio 5165418 43110-2069

Wright State Physicians Health Center /ID# 268841
Fairborn 4511263, Ohio 5165418 45324

Oregon Health and Science University /ID# 266483
Portland 5746545, Oregon 5744337 97239

Medical University of South Carolina /ID# 265113
Charleston 4574324, South Carolina 4597040 29425

International Clinical Research - Tennessee /ID# 268548
Murfreesboro 4644312, Tennessee 4662168 37130

Arlington Research Center, Inc /ID# 266330
Arlington 4671240, Texas 4736286 76011

3A Research - East location /ID# 267622
El Paso 5520993, Texas 4736286 79925

Prime Clinical Research - Mansfield - East Broad Street /ID# 268042
Mansfield 4709013, Texas 4736286 76063

Texas Dermatology and Laser Specialists /ID# 267249
San Antonio 4726206, Texas 4736286 78218
Contact:
Site Coordinator
210-852-2779

Progressive Clinical Research - San Antonio /ID# 267262
San Antonio 4726206, Texas 4736286 78229
Contact:
Site Coordinator
210-614-5557

Jordan Valley Dermatology & Research Center /ID# 267092
South Jordan 5781770, Utah 5549030 84095

West Virginia University Hospitals /ID# 265114
Morgantown 4815352, West Virginia 4826850 26506

Wisconsin Medical Center /ID# 267236
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Site Coordinator
(414) 955-5773

Clinical Research Investigator Group, LLC /ID# 268366
Bayamón 4562831, Puerto Rico 00960

Private Practice - Dr. Alma Cruz /ID# 264234
Carolina 4563243, Puerto Rico 00985

More Details

NCT ID
NCT06461897
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

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