Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461897
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
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
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Start Up
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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None