A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
NCT ID: NCT04626297
Last Updated: 2023-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
254 participants
INTERVENTIONAL
2020-11-17
2022-09-30
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
DOUBLE
Study Groups
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Lebrikizumab
Participants received a loading dose of 500 milligram (mg) lebrikizumab injection administered subcutaneously (SC) at baseline and week 2, and 250 mg once every two weeks (Q2W) from week 4 to 14.
Lebrikizumab
Given SC
Placebo
Participants received placebo SC injection Q2W from baseline to week 14.
Placebo
Given SC
Interventions
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Lebrikizumab
Given SC
Placebo
Given SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
* Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit.
* ≥10% Body Surface Area (BSA) of AD involvement at the baseline visit.
* History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
* Have not received any tetanus-containing vaccine within approximately 5 years of baseline.
* Have never received a meningococcal conjugate vaccine or have received not more than 1 prior MCV dose at least 4 years prior to baseline, of a vaccine containing 1 or more meningococcal serogroups (serogroups A, C, W, Y).
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* a. Female participants of childbearing potential: must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of study drug. Women of non-childbearing potential (non-WOCBP) may participate without any contraception requirements.
* b. Male participants are not required to use any contraception except in compliance with specific local government study requirements.
Exclusion Criteria
* Evidence of active or chronic hepatitis
* History of human immunodeficiency virus (HIV) infection or positive HIV serology.
* Presence of skin comorbidities that may interfere with study assessments.
* History of malignancy, including mycosis fungoides, within 5 years before screening, except completely treated in situ carcinoma of the cervix or completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
* Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma.
* Have a prior history of Guillain-Barre syndrome.
* Allergic to latex.
* History of past vaccination allergy or Arthus-type hypersensitivity.
* Have an uncontrolled seizure disorder.
* Have known hypogammaglobulinemia or a screening serum immunoglobulin G (IgG) or immunoglobulin A (IgA) concentration less than the lower limit of the reporting laboratory's reference range.
* Treated with topical corticosteroids (TCS), calcineurin inhibitors, or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit.
* Treated with the following prior to baseline visit:
* a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer
* b. B Cell-depleting biologics, including rituximab, within 6 months
* c. Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer
* Received a Bacillus Calmette-Guerin (BCG) vaccination or treatment within 12 months of screening, or treated with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
* A contraindication to the Tdap vaccine or mean corpuscular volume (MCV).
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
18 Years
55 Years
ALL
No
Sponsors
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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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Clinical Research Center of Alabama- Birmingham
Birmingham, Alabama, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Arkansas Research Trials
North Little Rock, Arkansas, United States
Orange County Research Institute
Anaheim, California, United States
Wallace Medical Group, Inc.
Beverly Hills, California, United States
First OC Dermatology
Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States
Axon Clinical Research
Inglewood, California, United States
Sunwise Clinical Research
Lafayette, California, United States
Avance Trials
Laguna Niguel, California, United States
Keck School of Medicine University of Southern California
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
LA Universal Research Center, INC
Los Angeles, California, United States
Ablon Skin Institute and Research Center
Manhattan Beach, California, United States
Dermatology Clinical Trials
Newport Beach, California, United States
Cura Clinical Research
Palmdale, California, United States
MD Strategies Research Centers MDSRC
San Diego, California, United States
University Clinical Trials
San Diego, California, United States
Synergy Dermatology
San Francisco, California, United States
Care Access Research
San Jose, California, United States
San Luis Dermatology & Laser Clinic
San Luis Obispo, California, United States
Southern California Dermatology, Inc.
Santa Ana, California, United States
IMMUNOe International Research Centers
Centennial, Colorado, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
The Community Research of South Florida
Hialeah, Florida, United States
Solutions Through Advanced Research
Jacksonville, Florida, United States
C&R Research Services USA
Kendall, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Sanchez Clinical Research Inc
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Miami Dermatology and Laser Research
Miami, Florida, United States
Florida Research Center, Inc
Miami, Florida, United States
Wellness Clinical Research
Miami Lakes, Florida, United States
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
Georgia Skin & Cancer Clinic
Savannah, Georgia, United States
Sneeze, Wheeze, & Itch Associates LLC
Normal, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Kansas City Dermatology, PA
Overland Park, Kansas, United States
Kansas Medical Clinic, an Elligo Health Research, Inc.
Shawnee Mission, Kansas, United States
Kansas Medical Clinic
Topeka, Kansas, United States
Skin Sciences, PLLC
Louisville, Kentucky, United States
Tulane Univ School of Med
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
Oakland Dermatology
Auburn Hills, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Advanced Dermatology of the Midlands
Omaha, Nebraska, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
Hackensack, New Jersey, United States
JUVA Skin & Laser Center
New York, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Central States Research
Tulsa, Oklahoma, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Peak Research LLC
Upper Saint Clair, Pennsylvania, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
AAPRI Clinical Research Institute
Warwick, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Arlington Research Center, Inc
Arlington, Texas, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Modern Research Associates
Dallas, Texas, United States
Austin Institute for Clinical Research
Dripping Springs, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Suzanne Bruce and Associates, PA
Houston, Texas, United States
Laredo Dermatology Associates P.A.
Laredo, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Velocity Clinical Research - Woseth Dermatology
Salt Lake City, Utah, United States
Jordan Valley Dermatology Center
South Jordan, Utah, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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References
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Soung J, Laquer V, Merola JF, Moore A, Elmaraghy H, Hu C, Piruzeli MLB, Pierce E, Garcia Gil E, Jarell AD. The Impact of Lebrikizumab on Vaccine-Induced Immune Responses: Results from a Phase 3 Study in Adult Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Aug;14(8):2181-2193. doi: 10.1007/s13555-024-01217-w. Epub 2024 Jul 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
Other Identifiers
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J2T-MC-KGAK
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002572-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17946
Identifier Type: -
Identifier Source: org_study_id
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