Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05507580
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2022-08-18
Brief Title:
A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3b4 Randomized Blinded Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects With Moderate to Severe Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Flex-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 evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD Adverse events and change in the disease activity will be assessed
Upadacitinib is an approved drug for the treatment of moderate to severeactive immune-mediated inflammatory diseases such as rheumatoid arthritis psoriatic arthritis ankylosing spondylitis ulcerative colitis UC Crohns Disease CD and AD The study is comprised of a 35-day Screening Period a 12-week double-blind period and a 12-week single-blind period During the double-blind period participants are placed in 1 of 2 groups called treatment arms and will be randomized in a 11 ratio to receive upadacitinib At 12 weeks during the single blind period participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 4 arms After the last study visit there is a 30-day follow-up visit Approximately 454 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide
The study is comprised of a 12-week double-blind period followed by a 12-week single-blind period Participants will receive upadacitinib oral tablets once daily for up to 24 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures 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 severeactive immune-mediated inflammatory diseases such as rheumatoid arthritis psoriatic arthritis ankylosing spondylitis ulcerative colitis UC Crohns Disease CD and AD The study is comprised of a 35-day Screening Period a 12-week double-blind period and a 12-week single-blind period During the double-blind period participants are placed in 1 of 2 groups called treatment arms and will be randomized in a 11 ratio to receive upadacitinib At 12 weeks during the single blind period participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 4 arms After the last study visit there is a 30-day follow-up visit Approximately 454 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide
The study is comprised of a 12-week double-blind period followed by a 12-week single-blind period Participants will receive upadacitinib oral tablets once daily for up to 24 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-000434-42 | EUDRACT_NUMBER | None | None |