Actively Recruiting
A Multicenter Open-Label Interventional Biomarker Study of Lutikizumab in Adults With Moderate-to-Severe Hidradenitis Suppurativa or Atopic Dermatitis
Led by AbbVie · Updated on 2025-01-24
60
Participants Needed
2
Research Sites
N/A
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 moderate to severe atopic dermatitis AD. This study includes two sub-studies, one for HS and one for AD, focusing on these chronic inflammatory skin diseases that cause painful skin lesions. The investigational drug lutikizumab ABT-981 is being studied to understand its effects on these conditions. Participants with HS or AD will receive subcutaneous injections of lutikizumab during a treatment period lasting up to 15 weeks for HS and 14 weeks for AD, followed by a 70-day follow-up. HS participants who show benefit at week 16 may enter a long-term extension to continue treatment for up to 140 weeks with weekly doses, plus another 70-day follow-up. Different participant groups include those new to biologic treatments and those with prior inadequate responses to certain therapies. Throughout the study, participants will attend regular visits at hospital or clinic sites for medical assessments, blood tests, and biomarker collection. Researchers will monitor adverse events up to approximately 30 weeks. The total study duration for each sub-study may last up to 30 weeks, with some participants potentially continuing in the long-term extension phase. The study aims to carefully assess treatment impact and safety in this adult population.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of moderate-to-severe hidradenitis suppurativa for at least 6 months prior to baseline for Sub-Study 1
- Participants must be either biologic-na�efve for HS or have had an inadequate or lost response to anti-TNF therapy for HS (12 or more weeks of therapy) for Sub-Study 1
- Diagnosis of moderate-to-severe atopic dermatitis with symptom onset at least 1 year prior to baseline for Sub-Study 2
- Participants must be either biologic-na�efve for AD or have had an inadequate or lost response to dupilumab therapy (8 or more weeks) for Sub-Study 2
You will not qualify if you...
- History of any malignancy within the last 5 years except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix
- History of active skin disease other than HS or AD that could interfere with assessment
- Current skin infections requiring systemic treatment within 4 weeks of baseline
Research Team
A
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