NIPH Clinical Trials Search

[M24-727]A Phase 2 Multicenter Platform Trial of Targeted Immunomodulator Therapies for Moderate to Severe Atopic Dermatitis

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Atopic Dermatitis
Date of first enrollment	17/03/2025
Target sample size	9
Countries of recruitment	United States of America,Japan,United Kingdom,Japan,South Korea,Japan
Study type	Interventional
Intervention(s)	Lutikizumab Monotherapy: In Period 1, participants will be receive lutikizumab Dose A at Baseline randomization, followed by Dose B every other week starting at Week 2 for 16 weeks. participants will continue into Period 2 at Week 16 with Dose C every other week until Week 52. Placebo to Lutikizumab: In Period 1, participants will be receive a matching placebo Dose A at Baseline randomization, followed by matching placebo Dose B every other week starting at Week 2 for 16 weeks. At Week 16, participants that were assigned placebo will then enter Period 2 and receive open-label lutikizumab Dose A , followed by lutikizumab Dose B every other week starting at Week 18, and lutikizumab Dose C every other week starting at Week 32 until Week 52.

Outcome(s)

Primary Outcome

- Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 - Percentage of Participants Who Reported Adverse Events

Secondary Outcome

- At Week 4 -- Percentage of Participants Achieving an Improvement (Reduction) of 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) - At Week 16 -- Percentage of Participants Achieving an EASI 50 Response -- Percentage of Participants Achieving an EASI 90 Response -- Percentage of Participants Achieving an EASI 100 Response -- Percentage of Participants Achieving a Validated Investigator's Global Assessmentfor AD (vIGA-AD) of 0 or 1 With a Reduction From Baseline of 2 Points -- Percentage of Participants Achieving an Improvement (Reduction) of 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) -- Absolute Change from Baseline for EASI -- Percent Change From Baseline in EASI Score -- Absolute Change from Baseline in Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) -- Percent Change From Baseline in Worst Pruritus Numerical Rating Scale(WP-NRS) -- Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) -- Absolute Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis(AD) Involvement -- Percent Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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).
Exclude 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-, 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.