A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis (NCT06461897)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Applied Research Center and Wellness Clinic /ID# 268547 — Little Rock, Arkansas
Age range: 2 Years to 11 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (150 Sites)
Showing the first 25 of 150 sites.
- Applied Research Center and Wellness Clinic /ID# 268547 — Little Rock, Arkansas
- Stanford University School of Medicine /ID# 269622 — Palo Alto, California
- Integrative Skin Science and Research /ID# 265108 — Sacramento, California
- Clearlyderm Dermatology - West Boca /ID# 266323 — Boca Raton, Florida
- Pediatric Skin Research - Coral Gables /ID# 266308 — Coral Gables, Florida
- Neoclinical Research - Hialeah /ID# 269694 — Hialeah, Florida
- Emory University School Of Medicine - Atlanta /ID# 268832 — Atlanta, Georgia
- Cleaver Medical Group Dermatology /ID# 265099 — Dawsonville, Georgia
- Aeroallergy Research Laboratory /ID# 267247 — Savannah, Georgia
- Treasure Valley Medical Research /ID# 266838 — Boise, Idaho
- Northwestern University Feinberg School of Medicine /ID# 265117 — Chicago, Illinois
- Sneeze Wheeze & Itch Associates /ID# 267238 — Normal, Illinois
- Dawes Fretzin /ID# 265097 — Indianapolis, Indiana
- Equity Medical, LLC /ID# 268270 — Bowling Green, Kentucky
- Maryland Allergy & Asthma Center /ID# 268032 — Lanham, Maryland
- DermAssociates - Rockville /ID# 266457 — Rockville, Maryland
- Washington University School of Medicine - St. Louis /ID# 268545 — St Louis, Missouri
- Skin Specialists /ID# 266331 — Omaha, Nebraska
- DOCS Clinical Research - Canal Winchester /ID# 268271 — Canal Winchester, Ohio
- Wright State Physicians Health Center /ID# 268841 — Fairborn, Ohio
- Oregon Health and Science University /ID# 266483 — Portland, Oregon
- Medical University of South Carolina /ID# 265113 — Charleston, South Carolina
- International Clinical Research - Tennessee /ID# 268548 — Murfreesboro, Tennessee
- Arlington Research Center, Inc /ID# 266330 — Arlington, Texas
- 3A Research - East location /ID# 267622 — El Paso, Texas
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atopic Dermatitis
- A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden — Birmingham, Alabama
- ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis — Phoenix, Arizona
- A Study of Barzolvolimab in Patients With Atopic Dermatitis — Birmingham, Alabama
- Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis — Chicago, Illinois
- A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis — Birmingham, Alabama
- A Study Evaluating APG777 in Atopic Dermatitis — Fountain Valley, California
Explore by condition: All Atopic Dermatitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.