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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.