Actively 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
Led by AbbVie · Updated on 2025-01-24
60
Participants Needed
2
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Participants in Sub-Study 1 (HS) who complete Week 16 and showed a therapeutic benefit to lutikizumab, as confirmed by the investigator, will have the option to enter an open-label long-term extension (LTE) to continue to receive lutikizumab for up to an additional 140 weeks, followed by a 70-day follow-up period. 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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For hidradenitis suppurativa (HS): diagnosis of moderate-to-severe HS for at least 6 months prior to baseline
- For HS: no prior biologic treatment or inadequate response/loss of response to anti-TNF therapy (at least 12 weeks of therapy)
- For atopic dermatitis (AD): diagnosis of moderate-to-severe AD with symptoms onset at least 1 year prior to baseline
- For AD: no prior biologic treatment or inadequate response/loss of response to dupilumab (at least 8 weeks of therapy)
You will not qualify if you...
- History of any malignancy within the last 5 years except successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix
- History of active skin disease other than HS for HS sub-study or AD for AD sub-study that could interfere with assessment
- Skin infections requiring systemic treatment within 4 weeks of baseline
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Physioseq, LLC /ID# 267266
Sacramento, California, United States, 95825
Actively Recruiting
2
University of Michigan Health System - Ann Arbor /ID# 267275
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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