A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT03443024
Last Updated: 2021-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
280 participants
INTERVENTIONAL
2018-01-30
2019-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)
125 mg Lebrikizumab administered subcutaneously (SC) once Q4W.
Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-milliliter (mL) of 125 mg/mL Lebrikizumab and 1-mL placebo).
Week 2: Four 1-mL SC injections placebo.
Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo.
Weeks 6, 10, 14: Two 1-mL SC placebo.
Lebrikizumab
Sterile liquid solution administered subcutaneously.
Placebo
Solution administered subcutaneously.
250 mg Lebrikizumab - Q4W
250 mg Lebrikizumab administered SC once Q4W.
Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab).
Week 2: Four 1-mL SC injections of placebo.
Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab).
Weeks 6, 10, 14: Two 1-mL injections of placebo.
Lebrikizumab
Sterile liquid solution administered subcutaneously.
Placebo
Solution administered subcutaneously.
250 mg Lebrikizumab - Every 2 Weeks (Q2W)
250 mg Lebrikizumab administered SC once Q2W.
Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab).
Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab).
Lebrikizumab
Sterile liquid solution administered subcutaneously.
Placebo
Solution administered subcutaneously.
Group 4 - Placebo
Placebo administered SC once Q2W.
Baseline and Week 2: Four 1-mL SC injections of placebo.
Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo.
Placebo
Solution administered subcutaneously.
Interventions
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Lebrikizumab
Sterile liquid solution administered subcutaneously.
Placebo
Solution administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .
* Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.
* Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.
* ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.
Exclusion Criteria
* Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
* Phototherapy and photochemotherapy (PUVA) for AD.
* Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit.
* Treatment with:
* An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.
* Dupilumab within 3 months prior to baseline visit.
* Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.
* Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer).
* Use of prescription moisturizers within 7 days of the baseline visit.
18 Years
ALL
No
Sponsors
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Dermira, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, United States
Dermatology Trial Associates
Bryant, Arkansas, United States
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
University of Southern California
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Stanford Medicine Outpatient Center-Medical Dermatology Clinic
Redwood City, California, United States
Center for Dermatology and Laser Surgery
Sacramento, California, United States
UCSD Dermatology
San Diego, California, United States
TCR Medical Corporation
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
Total Vein and Skin
Boynton Beach, Florida, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, United States
Olympian Clinical Research
Largo, Florida, United States
Tory Sullivan, MD PA
North Miami Beach, Florida, United States
International Clinical Research - US, LLC
Sanford, Florida, United States
Integrated Clinical Research, LLC
West Palm Beach, Florida, United States
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, United States
Advanced Medical Research, PC
Sandy Springs, Georgia, United States
Dundee Dermatology
West Dundee, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Kansas City Dermatology, PA
Overland Park, Kansas, United States
Skin Sciences, PLLC
Louisville, Kentucky, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, United States
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, United States
ActivMed Practices & Research, Inc.
Beverly, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States
Somerset Skin Centre
Troy, Michigan, United States
JDR Dermatology Research
Las Vegas, Nevada, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Schweiger Dermatology, PLLC
New York, New York, United States
Icahn School of Medicine
New York, New York, United States
Sadick Research Group, LLC.
New York, New York, United States
DermResearchCenter of New York, Inc.
Stony Brook, New York, United States
Piedmont Plastic Surgery and Dermatology
Charlotte, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
Rivergate Dermatology Clinical Research Center
Goodlettsville, Tennessee, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
Westlake Dermatology Clinical Research Center
Austin, Texas, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Menter Dermatology Research
Dallas, Texas, United States
The University of Texas Health
Houston, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Dermatology Associates of Seattle
Seattle, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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References
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Rams A, Baldasaro J, Bunod L, Delbecque L, Strzok S, Meunier J, ElMaraghy H, Sun L, Pierce E. Assessing Itch Severity: Content Validity and Psychometric Properties of a Patient-Reported Pruritus Numeric Rating Scale in Atopic Dermatitis. Adv Ther. 2024 Apr;41(4):1512-1525. doi: 10.1007/s12325-024-02802-3. Epub 2024 Feb 16.
Guttman-Yassky E, Blauvelt A, Eichenfield LF, Paller AS, Armstrong AW, Drew J, Gopalan R, Simpson EL. Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis: A Phase 2b Randomized Clinical Trial. JAMA Dermatol. 2020 Apr 1;156(4):411-420. doi: 10.1001/jamadermatol.2020.0079.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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J2T-DM-KGAF
Identifier Type: OTHER
Identifier Source: secondary_id
DRM06-AD01
Identifier Type: OTHER
Identifier Source: secondary_id
17826
Identifier Type: -
Identifier Source: org_study_id
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