Who Can Participate?
Children aged 2 to less than 12 with moderate to severe eczema may participate.
Inclusion Criteria
* 1% of your child’s body surface area is roughly equal to the palm of your child’s hand (no wrist or fingers).
Additional Information
How Long Will The Study Last?
Canal Winchester - DOCS Clinical Research – Canal Winchester
Halifax - Maritime Dermatology
Toronto - DermAtelier on Avenue
Hamilton - LEADER Research
Niagara Falls - Allergy Research Canada Inc.
Markham - Lynderm Research Inc.
Calgary - Dermatology Research Institute
No Doctors Found
Similar Trials
No Similar Trials FoundThe following information is from ClinicalTrials.gov
Last Update Posted: November 27, 2024
NCT06461897
AbbVie
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. 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 or Disease:
Atopic Dermatitis
Intervention/Treatment:
Drug: Upadacitinib Drug: Upadacitinib,Drug: DupilumabPhase:
PHASE 3
Ages Eligible for Study:
2 years to less than 12 years (CHILD)
Sexes Eligible for Study:
ALL
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