Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05601882
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2022-10-31
Brief Title:
A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3b4 Randomized Open-label Efficacy Assessor Blinded Study Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis Level-Up
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:
Level 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 compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies Adverse events and change in the disease activity will be assessed
Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis AD The study is comprised of a 35-day Screening Period a 16-week treatment period 1 and a 16-week treatment period 2 During period 1 participants are randomly assigned in 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab In Period 2 participants will receive upadacitinib Dose A or Dose B Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide
Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label 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 and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis AD The study is comprised of a 35-day Screening Period a 16-week treatment period 1 and a 16-week treatment period 2 During period 1 participants are randomly assigned in 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab In Period 2 participants will receive upadacitinib Dose A or Dose B Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide
Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002482-15 | EUDRACT_NUMBER | None | None |