Actively Recruiting
Study of Lutikizumab Injections in Adults With Moderate-to-Severe Hidradenitis Suppurativa or Atopic Dermatitis Open-Label Interventional Biomarker Study Led by AbbVie
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
Researchers are evaluating molecular changes in adults with moderate to severe hidradenitis suppurativa (HS) or atopic dermatitis (AD), both chronic inflammatory skin diseases causing painful lesions and discomfort. This Phase 2 study includes two sub-studies focusing separately on HS and AD to better understand these conditions. The investigational drug lutikizumab (ABT-981) is being studied for its potential effects in these skin diseases. Participants with HS or AD will receive subcutaneous injections of lutikizumab over approximately 14 to 15 weeks, followed by a 70-day follow-up period. Those in the HS sub-study who show benefit at week 16 may continue treatment in an open-label long-term extension for up to an additional 140 weeks, with another 70-day follow-up after that. About 60 participants will be enrolled across two US sites. During the study, participants will attend regular hospital or clinic visits that include frequent medical assessments, blood tests, and biomarker collection. The number of participants experiencing adverse events will be monitored up to about 30 weeks. The study duration may be longer for those joining the extension period, and participants should expect a higher treatment burden than standard care.
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
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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