Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389136
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-04-25
Brief Title:
A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3b4 Randomized Open-label Efficacy Assessor-Blinded Study to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab SWITCH-UP
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:
Switch-Up
Brief Summary:
Atopic dermatitis AD is a skin condition that may cause a rash and itching due to inflammation of the skin Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD
Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis AD This study is conducted in 2 periods During Period 1 participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab Dose A Based on the participants response to upadacitinib Dose A they may have their dose increased to upadacitinib Dose B after 2 weeks In Period 2 participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index EASI response Approximately 300 adult participants ages 18 to 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 94 sites worldwide
The study is comprised of a 35-day Screening Period an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1 Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous SC injection every other week for 32 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 medical assessments blood tests checking for side effects and completing questionnaires
Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis AD This study is conducted in 2 periods During Period 1 participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab Dose A Based on the participants response to upadacitinib Dose A they may have their dose increased to upadacitinib Dose B after 2 weeks In Period 2 participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index EASI response Approximately 300 adult participants ages 18 to 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 94 sites worldwide
The study is comprised of a 35-day Screening Period an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1 Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous SC injection every other week for 32 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 medical 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?:
True
Is an FDA AA801 Violation?:
None