Status:
RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Hidradenitis Suppurativa
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- Sub-Study 1 hidradenitis suppurativa (HS):
- Participants with a diagnosis of moderate-to-severe HS for at least 6 months prior to Baseline as determined by the investigator
- Participants naïve to biologic treatment for HS or must have a prior inadequate response or loss of response to anti-TNF therapy for HS (\>= 12 weeks of therapy).
- Sub-Study 2 atopic dermatitis (AD):
- Participants with a diagnosis of moderate-to-severe AD with onset of symptoms at least 1 year prior to Baseline.
- Participants naïve to biologic treatment for AD or must have a prior inadequate response or loss of response to dupilumab for AD (defined as \>= 8 weeks of therapy with dupilumab).
Exclusion
- History of any malignancy within the last 5 years except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
- History of active skin disease (other than HS for Sub-Study 1 or AD for Sub-Study 2) that could interfere with the assessment of HS (for Sub-Study 1) or AD (for Sub-Study 2), including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline.
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06524635
Start Date
August 14 2024
End Date
February 1 2027
Last Update
January 24 2025
Active Locations (2)
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1
Physioseq, LLC /ID# 267266
Sacramento, California, United States, 95825
2
University of Michigan Health System - Ann Arbor /ID# 267275
Ann Arbor, Michigan, United States, 48109