A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis

Launched by ABBVIE · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at new treatments for moderate to severe atopic dermatitis (AD), a skin condition that causes itchy rashes due to inflammation. The study will test a medication called lutikizumab, both alone and in combination with other therapies, to see how effective and safe it is for people who have not had enough relief from their current treatments. The trial will involve different groups of participants, with some receiving lutikizumab and others receiving a placebo (a treatment with no active medication), over a total of 52 weeks.

To participate in this trial, individuals must have a confirmed diagnosis of atopic dermatitis for at least one year and have not responded well to standard treatments like topical creams or other therapies. Participants will have to visit a clinic regularly for assessments, blood tests, and other evaluations, which may require more time and commitment than their usual care. It's important to note that participants should not have used certain medications for a specific period before joining the trial, as this ensures the study's results are reliable. If you're interested or think you might qualify, discussing this with a healthcare provider can help you understand your options better.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of AD with onset of symptoms at least 1 year prior to the Baseline Visit and participant meets Hanifin and Rajka criteria.
• • Participant has applied non-medicated, additive-free bland emollient twice daily for at least 7 days before the Baseline Visit.
• • History of inadequate response to topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or topical JAK inhibitors, OR systemic treatment for AD, OR participants for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
• Exclusion Criteria:
• * Use of the following AD treatments within the specified washout period prior to the Baseline Visit:
• • -- Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4) inhibitors, IFN-γ, and mycophenolate mofetil within 5 half-lives \[if known\] or within 4 weeks, whichever is longer;
• • -- Any biologic treatments, (within 5 half-lives \[if known\]) or within 12 weeks (whichever is longer), or as specified below: \< 8 weeks for dupilumab; \< 12 weeks for nemolizumab; \< 16 weeks for tralokinumab and lebrikizumab.
• • Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
• • Herbal treatments (e.g., traditional Chinese medicines) within 4 weeks.
• • Topical treatments (with the exception of non-medicated, additive-free bland emollients), including but not limited to TCS, TCIs, or topical PDE-4 inhibitors within 7 days.
• • Topical JAK inhibitor within 14 days.
• • Systemic JAK inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, upadacitinib, abrocitinib \[PF-04965842\], and filgotinib) within 5 half-lives \[if known\] or within 14 days, whichever is longer.