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A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis
Sponsor: AbbVie
Summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to evaluate the clinical efficacy and safety of single therapies and/or combination therapies for moderate to severe AD through multiple substudies. 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.
Official title: A Phase 2 Multicenter Platform Trial of Targeted Immunomodulator Therapies for Moderate to Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2024-12-19
Completion Date
2027-05
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Lutikizumab
Subcutaneous (SC) Injection
Placebo
Subcutaneous (SC) Injection
Locations (30)
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