A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis
NCT ID: NCT06718101
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2024-12-19
2027-05-31
Brief Summary
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This study will consist of multiple sub-studies, Sub-Study 1 will have a randomized, placebo controlled period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio.
In Sub-Study 1, participants will receive subcutaneous (SC) injections of lutikizumab or matching placebo every other week for 16 weeks followed by an additional 32 weeks of subcutaneous (SC) injections of lutikizumab every other week for a total of 52 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sub-Study 1: 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.
Lutikizumab
Subcutaneous (SC) Injection
Sub-Study 1: 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.
Lutikizumab
Subcutaneous (SC) Injection
Placebo
Subcutaneous (SC) Injection
Interventions
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Lutikizumab
Subcutaneous (SC) Injection
Placebo
Subcutaneous (SC) Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
\-- 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550
Fountain Hills, Arizona, United States
Dermatology Research Associates - Los Angeles /ID# 272945
Los Angeles, California, United States
Integrative Skin Science and Research /ID# 274243
Sacramento, California, United States
Clinical Trials Research Institute /ID# 274234
Thousand Oaks, California, United States
Western States Clinical Res /ID# 271748
Wheat Ridge, Colorado, United States
Skin Care Research Boca Raton /ID# 272544
Boca Raton, Florida, United States
Research Associates of South Florida /ID# 272549
Miami, Florida, United States
Advanced Clinical Research Institute /ID# 272558
Tampa, Florida, United States
Encore Medical Research - Weston /ID# 272539
Weston, Florida, United States
Arlington Dermatology /ID# 271735
Rolling Meadows, Illinois, United States
Somnos Clinical Research /ID# 272943
Lincoln, Nebraska, United States
Equity Medical, LLC /ID# 272555
New York, New York, United States
Oregon Dermatology & Research Center /ID# 271733
Portland, Oregon, United States
Clinical Partners /ID# 271791
Johnston, Rhode Island, United States
Health Concepts /ID# 271744
Rapid City, South Dakota, United States
Orion Clinical Research /ID# 274236
Austin, Texas, United States
Complete Dermatology - Sugar Land /ID# 274240
Sugar Land, Texas, United States
Dermatology Associates of Tyler /ID# 273684
Tyler, Texas, United States
Center for Clinical Studies - Clear Lake /ID# 271749
Webster, Texas, United States
Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619
Sapporo, Hokkaido, Japan
Kyoto University Hospital /ID# 275237
Kyoto, Kyoto, Japan
Tachikawa Dermatology Clinic /ID# 273620
Tachikawa-shi, Tokyo, Japan
Korea University Ansan Hospital /ID# 271786
Ansan-si, Gyeonggido, South Korea
Soon Chun Hyang University Hospital Bucheon /ID# 271788
Bucheon-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 271787
Seoul, Seoul Teugbyeolsi, South Korea
Konkuk University Medical Center /ID# 271789
Seoul, Seoul Teugbyeolsi, South Korea
Hallym University Kangnam Sacred Heart Hospital /ID# 271785
Seoul, Seoul Teugbyeolsi, South Korea
Royal United Hospital /ID# 274328
Bath, Bath And North East Somerset, United Kingdom
Chapel Allerton Hospital /ID# 274762
Leeds, West Yorkshire, United Kingdom
Royal Liverpool University Hospital /ID# 272584
Liverpool, , United Kingdom
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M24-727
Identifier Type: -
Identifier Source: org_study_id
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