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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 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Dupilumab
- DRUG Upadacitinib
Study Locations (20)
Florida
- Clearlyderm Dermatology - West Boca /ID# 266323 — Boca Raton
- Pediatric Skin Research /ID# 266308 — Coral Gables
- Neoclinical Research - Hialeah /ID# 269694 — Hialeah
California
- Stanford University School of Medicine - Palo Alto /ID# 269622 — Palo Alto
- Integrative Skin Science and Research /ID# 265108 — Sacramento
Georgia
- Cleaver Medical Group Dermatology /ID# 265099 — Dawsonville
- Aeroallergy Research Laboratory /ID# 267247 — Savannah
Illinois
- Northwestern University Feinberg School of Medicine /ID# 265117 — Chicago
- Sneeze Wheeze & Itch Associates /ID# 267238 — Normal
Maryland
- Maryland Allergy & Asthma Center /ID# 268032 — Lanham
- DermAssociates - Rockville /ID# 266457 — Rockville
Ohio
- DOCS Clinical Research - Canal Winchester /ID# 268271 — Canal Winchester
- Wright State Physicians Health Center /ID# 268841 — Fairborn
Arkansas
- Applied Research Center Of Arkansas /ID# 268547 — Little Rock
Idaho
- Treasure Valley Medical Research /ID# 266838 — Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2030-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06461897
The ClinicalTrials.gov registry entry for NCT06461897 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 675 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions — of which Dupilumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06461897 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06461897 about?
NCT06461897 is a clinical study titled "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". 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 dupilu...
What is the current status of trial NCT06461897?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 675 participants. The study started on 2024-08-19. Estimated completion is 2030-07.
What conditions does trial NCT06461897 study?
This clinical trial studies the following conditions: Atopic Dermatitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06461897?
The interventions under investigation include: Dupilumab (DRUG), Upadacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06461897?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06461897 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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