Assessing molecular changes in adults with moderate to severe skin conditions receiving Lutikizumab

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

This study is testing a new drug called Lutikizumab to see if it can help adults with moderate to severe skin conditions like hidradenitis suppurativa and atopic dermatitis feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: AbbVie (industry)
• Drugs / interventions: dupilumab, Lutikizumab
• Locations: 2 sites (Sacramento, California and 1 other locations)
• Trial ID: NCT06524635 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of Lutikizumab, an investigational drug, on adults with moderate to severe hidradenitis suppurativa (HS) and atopic dermatitis (AD). It consists of two sub-studies: one for HS participants receiving subcutaneous injections for up to 15 weeks, and another for AD participants receiving injections for up to 14 weeks, followed by a 70-day follow-up period. Approximately 60 participants will be enrolled across two sites in the US to assess molecular changes associated with these chronic inflammatory skin diseases.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with moderate to severe HS or AD who have not responded adequately to previous biologic treatments.

Not a fit: Patients with a history of malignancy within the last 5 years or those with active skin diseases unrelated to HS or AD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from moderate to severe hidradenitis suppurativa and atopic dermatitis.

How similar studies have performed: Other studies have shown promise with similar biologic treatments for HS and AD, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Sacramento, California and 1 other locations

• Physioseq, LLC /ID# 267266 — Sacramento, California, United States (RECRUITING)
• University of Michigan Health System - Ann Arbor /ID# 267275 — Ann Arbor, Michigan, United States (RECRUITING)

Study contacts

• Study coordinator: ABBVIE CALL CENTER

Conditions: Hidradenitis Suppurativa, Atopic Dermatitis, Lutikizumab, ABT-981