Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524635
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic Dermatitis Receiving Subcutaneous Injections of Lutikizumab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Open-Label Interventional Biomarker Study of Lutikizumab in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa or Adult Subjects 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hidradenitis suppurativa HS and atopic dermatitis AD are chronic inflammatory skin diseases that lead to the development of skin lesions and symptoms such as pain and discomfort The purpose of this study is to assess molecular changes in adult participants with moderate to severe HS or with moderate to severe AD
Lutikizumab ABT-981 is an investigational drug being developed for the treatment of HS and AD This study will consist of 2 sub-studies Sub-Study 1 moderate to severe hidradenitis suppurativa and Sub-Study 2 moderate to severe atopic dermatitis Approximate 60 participants will be enrolled in the study at approximately 2 sites in the US
In Sub-Study 1 HS participants will receive subcutaneous SC injections of lutikizumab for up to week 15 with a 70-day follow-up period In Sub-Study 2 AD participants will receive subcutaneous SC injections of lutikizumab for up to week 14 with a 70-day follow-up period The study duration for Sub-Studies 1 and 2 is expected to last up to 30 weeks
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 and may require frequent medical assessments blood tests and biomarker collections
Lutikizumab ABT-981 is an investigational drug being developed for the treatment of HS and AD This study will consist of 2 sub-studies Sub-Study 1 moderate to severe hidradenitis suppurativa and Sub-Study 2 moderate to severe atopic dermatitis Approximate 60 participants will be enrolled in the study at approximately 2 sites in the US
In Sub-Study 1 HS participants will receive subcutaneous SC injections of lutikizumab for up to week 15 with a 70-day follow-up period In Sub-Study 2 AD participants will receive subcutaneous SC injections of lutikizumab for up to week 14 with a 70-day follow-up period The study duration for Sub-Studies 1 and 2 is expected to last up to 30 weeks
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 and may require frequent medical assessments blood tests and biomarker collections
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None