A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
A Phase 3, 16-week, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Assess the Impact of Lebrikizumab on Vaccine Responses in Adult Patients With Moderate-to-Severe Atopic Dermatitis
3 other identifiers
interventional
254
1 country
85
Brief Summary
The reason for this study is to assess the impact of lebrikizumab on vaccine immune response in adult participants with moderate to severe atopic dermatitis (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2020
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedStudy Start
First participant enrolled
November 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedResults Posted
Study results publicly available
August 28, 2023
CompletedOctober 17, 2023
October 1, 2023
1.7 years
November 6, 2020
August 2, 2023
October 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Develop a Booster Response to Tetanus Toxoid 4 Weeks After Tdap (Tetanus-diphtheria-pertussis) Vaccine Administration
Booster response to tetanus toxoid is defined as: ≥4-fold increase in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration if the pre-vaccination level was \>0.10 International units per milliliter (IU/mL) and ≤2.7 IU/mL; OR ≥2-fold increase in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination level was \>2.7 IU/mL; OR ≥4-fold increase in anti-tetanus toxoid IgG antibody concentration and a post-vaccination level ≥0.10 IU/mL if the pre-vaccination level was ≤0.10 IU/mL
Week 16
Percentage of Participants Who Have Positive Antibody Response to Meningococcus C Antigen 4 Weeks After Meningococcal Conjugate Vaccine (MCV) Administration
Positive antibody response to Meningococcus C antigen as measured by group C serum bactericidal antibodies is defined as: post-vaccination rabbit complement serum bactericidal assay (rSBA) titer ≥4 times the lower limit of quantitation (LLOQ), if the pre-vaccination rSBA titer is less than the LLOQ; OR post-vaccination rSBA titer ≥4 times the pre-vaccination titer, if the pre-vaccination rSBA titer is greater than or equal to the LLOQ.
Week 16
Secondary Outcomes (6)
Percentage of Participants Achieving an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction of ≥2 Points From Baseline
Week 16
Percentage of Participants Achieving a ≥75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-75)
Week 16
Percentage of Participants Achieving ≥90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-90)
Week 16
Percentage of Participants Achieving ≥4-Point Improvement From Baseline in Pruritus Numeric Rating Scale (NRS) Score
Week 16
Change From Baseline in Percent Body Surface Area (BSA)
Baseline, Week 16
- +1 more secondary outcomes
Study Arms (2)
Lebrikizumab
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants received placebo SC injection Q2W from baseline to week 14.
Interventions
Eligibility Criteria
You may qualify if:
- Chronic atopic dermatitis (AD) according to American Academy of Dermatology Consensus Criteria that has been present for ≥1 year before screening.
- 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.
You may not qualify if:
- Recurring herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Clinical Research Center of Alabama- Birmingham
Birmingham, Alabama, 35244, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Arkansas Research Trials
North Little Rock, Arkansas, 72117, United States
Orange County Research Institute
Anaheim, California, 92801, United States
Wallace Medical Group, Inc.
Beverly Hills, California, 90211, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Axon Clinical Research
Inglewood, California, 90301, United States
Sunwise Clinical Research
Lafayette, California, 94549, United States
Avance Trials
Laguna Niguel, California, 92677, United States
Keck School of Medicine University of Southern California
Los Angeles, California, 90033, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
LA Universal Research Center, INC
Los Angeles, California, 90057, United States
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266, United States
Dermatology Clinical Trials
Newport Beach, California, 92660, United States
Cura Clinical Research
Palmdale, California, 93551, United States
MD Strategies Research Centers MDSRC
San Diego, California, 92119, United States
University Clinical Trials
San Diego, California, 92123, United States
Synergy Dermatology
San Francisco, California, 94132, United States
Care Access Research
San Jose, California, 95117, United States
San Luis Dermatology & Laser Clinic
San Luis Obispo, California, 93405, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
IMMUNOe International Research Centers
Centennial, Colorado, 80112, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907-6231, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
The Community Research of South Florida
Hialeah, Florida, 33016, United States
Solutions Through Advanced Research
Jacksonville, Florida, 32256, United States
C&R Research Services USA
Kendall, Florida, 33183, United States
International Dermatology Research, Inc.
Miami, Florida, 33144, United States
Sanchez Clinical Research Inc
Miami, Florida, 33157, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Miami Dermatology and Laser Research
Miami, Florida, 33173, United States
Florida Research Center, Inc
Miami, Florida, 33174, United States
Wellness Clinical Research
Miami Lakes, Florida, 33016, United States
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, 33028, United States
Tampa General Hospital
Tampa, Florida, 33612, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Olympian Clinical Research
Tampa, Florida, 33614, United States
Advanced Medical Research
Sandy Springs, Georgia, 30328, United States
Georgia Skin & Cancer Clinic
Savannah, Georgia, 31419, United States
Sneeze, Wheeze, & Itch Associates LLC
Normal, Illinois, 61761, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Kansas City Dermatology, PA
Overland Park, Kansas, 66215, United States
Kansas Medical Clinic, an Elligo Health Research, Inc.
Shawnee Mission, Kansas, 66216, United States
Kansas Medical Clinic
Topeka, Kansas, 66614, United States
Skin Sciences, PLLC
Louisville, Kentucky, 40217, United States
Tulane Univ School of Med
New Orleans, Louisiana, 70112, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135, United States
Oakland Dermatology
Auburn Hills, Michigan, 48326, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Advanced Dermatology of the Midlands
Omaha, Nebraska, 68144, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
Hackensack, New Jersey, 07601, United States
JUVA Skin & Laser Center
New York, New York, 10022-3350, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414, United States
Unity Clinical Research
Oklahoma City, Oklahoma, 73118, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Peak Research LLC
Upper Saint Clair, Pennsylvania, 15241, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
AAPRI Clinical Research Institute
Warwick, Rhode Island, 02886, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Arlington Research Center, Inc
Arlington, Texas, 76011, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401, United States
Dermatology Treatment and Research Center
Dallas, Texas, 75230, United States
Modern Research Associates
Dallas, Texas, 75231, United States
Austin Institute for Clinical Research
Dripping Springs, Texas, 78620, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
Suzanne Bruce and Associates, PA
Houston, Texas, 77056, United States
Laredo Dermatology Associates P.A.
Laredo, Texas, 78041, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Velocity Clinical Research - Woseth Dermatology
Salt Lake City, Utah, 84117, United States
Jordan Valley Dermatology Center
South Jordan, Utah, 84095, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Related Publications (1)
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.
PMID: 39009804DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 12, 2020
Study Start
November 17, 2020
Primary Completion
August 3, 2022
Study Completion
September 30, 2022
Last Updated
October 17, 2023
Results First Posted
August 28, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.