Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05451316
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2022-07-07
Brief Title:
A Study to Assess Change in Disease Activity in Adolescents and Adults With Moderate to Severe Prurigo-type Atopic Dermatitis in Japan Who Are Treated With Oral Upadacitinib
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in the Real World in Japan
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ADMIRE
Brief Summary:
Atopic dermatitis AD is a skin condition that may cause a rash and itching due to inflammation of the skin Around one-third of patients with AD have had at least 1 incidence of prurigo nodularis PN which is characterized by intense persistent itchy skin and sometimes pain with burning In this study the effectiveness of upadacitinib UPA will be assessed in participants with prurigo-type AD in a real world RW setting in Japan
UPA is an approved drug for the treatment of AD Adults and adolescents who have been diagnosed with prurigo-type AD and prescribed UPA according to the label and practice in Japan will be enrolled in this observational study The doctors decision to prescribe UPA will be made prior to and independently of study participation Approximately 200 participants will be enrolled in the study at 10 sites in Japan
Participants will receive extended-release oral tablets of UPA once-daily for 48 weeks
There will be no additional burden for participants in this trial compared to their standard of care Participants will attend regular visits during the course of the study at a hospital or clinic
UPA is an approved drug for the treatment of AD Adults and adolescents who have been diagnosed with prurigo-type AD and prescribed UPA according to the label and practice in Japan will be enrolled in this observational study The doctors decision to prescribe UPA will be made prior to and independently of study participation Approximately 200 participants will be enrolled in the study at 10 sites in Japan
Participants will receive extended-release oral tablets of UPA once-daily for 48 weeks
There will be no additional burden for participants in this trial compared to their standard of care Participants will attend regular visits during the course of the study at a hospital or clinic
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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