A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
- Registration Number
- NCT04626297
- Lead Sponsor
- Eli Lilly and Company
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
-
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.
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo SC injection Q2W from baseline to week 14. Lebrikizumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Develop a Booster Response to Tetanus Toxoid 4 Weeks After Tdap (Tetanus-diphtheria-pertussis) Vaccine Administration Week 16 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
Percentage of Participants Who Have Positive Antibody Response to Meningococcus C Antigen 4 Weeks After Meningococcal Conjugate Vaccine (MCV) Administration Week 16 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving a ≥75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-75) Week 16 The EASI-75 is defined as a ≥ 75% improvement from baseline in the EASI score. EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. MCMC-MI was used to handle missing data.
Percentage of Participants Achieving an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction of ≥2 Points From Baseline Week 16 The IGA measures the investigator's global assessment of the participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.
Percentage of Participants Achieving ≥90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-90) Week 16 The EASI-90 is defined as a ≥ 90% improvement from baseline in the EASI score. EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. MCMC-MI was used to handle missing data.
Change From Baseline in Sleep-Loss Score Baseline, Week 16 Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all)\]. Higher scores indicate a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary, and the week 16 score was calculated by averaging the daily scores from the previous 7 days and the average score was used to compute a change from baseline. MCMC-MI was used to handle missing data.
Percentage of Participants Achieving ≥4-Point Improvement From Baseline in Pruritus Numeric Rating Scale (NRS) Score Week 16 The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." MCMC-MI was used to handle missing data.
Change From Baseline in Percent Body Surface Area (BSA) Baseline, Week 16 The BSA assessment estimates the extent of disease or skin involvement with respect to AD and is expressed as a percentage of body surface area. It was assessed for 4 body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100%. BSA was calculated using the participant's palm, 1 palm = 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 for head and neck (10%), 20 for upper extremities (20%), 30 for trunk, including axilla and groin (30%), and 40 for lower extremities, including buttocks (40%). Percent of BSA for a body region = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA for an individual is arithmetic mean of % BSA of all 4 body regions and ranges from 0% to 100% with higher values representing greater severity of AD.
Trial Locations
- Locations (84)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Modern Research Associates
🇺🇸Dallas, Texas, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, 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
San Luis Dermatology & Laser Clinic
🇺🇸San Luis Obispo, California, United States
Southern California Dermatology, Inc.
🇺🇸Santa Ana, California, United States
Asthma and Allergy Associates, PC
🇺🇸Colorado Springs, Colorado, United States
Care Access Research
🇺🇸San Jose, California, United States
The Community Research of South Florida
🇺🇸Hialeah, Florida, United States
JUVA Skin & Laser Center
🇺🇸New York, New York, United States
Suzanne Bruce and Associates, PA
🇺🇸Houston, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
MD Strategies Research Centers MDSRC
🇺🇸San Diego, California, United States
University Clinical Trials
🇺🇸San Diego, California, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Kansas Medical Clinic
🇺🇸Topeka, Kansas, United States
Synergy Dermatology
🇺🇸San Francisco, California, United States
Unity Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Velocity Clinical Research - Woseth Dermatology
🇺🇸Salt Lake City, Utah, United States
Advanced Dermatology of the Midlands
🇺🇸Omaha, Nebraska, United States
Kansas City Dermatology, PA
🇺🇸Overland Park, Kansas, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Florida Academic Centers Research and Education, LLC
🇺🇸Coral Gables, Florida, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
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
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
Avance Trials
🇺🇸Laguna Niguel, California, United States
Sunwise Clinical Research
🇺🇸Lafayette, California, United States
Keck School of Medicine University of Southern California
🇺🇸Los Angeles, California, United States
Dermatology Clinical Trials
🇺🇸Newport Beach, California, United States
Ablon Skin Institute and Research Center
🇺🇸Manhattan Beach, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
LA Universal Research Center, INC
🇺🇸Los Angeles, California, United States
Cura Clinical Research
🇺🇸Palmdale, California, United States
IMMUNOe International Research Centers
🇺🇸Centennial, Colorado, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Solutions Through Advanced Research
🇺🇸Jacksonville, Florida, United States
C&R Research Services USA
🇺🇸Kendall, Florida, United States
Wellness Clinical Research
🇺🇸Miami Lakes, Florida, United States
Georgia Skin & Cancer Clinic
🇺🇸Savannah, Georgia, United States
Advanced Medical Research
🇺🇸Sandy Springs, Georgia, United States
Riverchase Dermatology and Cosmetic Surgery
🇺🇸Pembroke Pines, Florida, United States
Sneeze, Wheeze, & Itch Associates LLC
🇺🇸Normal, Illinois, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Dundee Dermatology
🇺🇸West Dundee, Illinois, United States
Kansas Medical Clinic, an Elligo Health Research, Inc.
🇺🇸Shawnee Mission, Kansas, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Metro Boston Clinical Partners
🇺🇸Brighton, Massachusetts, United States
Oakland Dermatology
🇺🇸Auburn Hills, Michigan, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, 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
Ohio Pediatric Research Association
🇺🇸Dayton, Ohio, 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
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Peak Research LLC
🇺🇸Upper Saint Clair, Pennsylvania, United States
AAPRI Clinical Research Institute
🇺🇸Warwick, Rhode Island, United States
Bellaire Dermatology Associates
🇺🇸Bellaire, Texas, United States
Arlington Research Center, Inc
🇺🇸Arlington, Texas, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
Austin Institute for Clinical Research
🇺🇸Dripping Springs, Texas, United States
Laredo Dermatology Associates P.A.
🇺🇸Laredo, Texas, United States
Jordan Valley Dermatology Center
🇺🇸South Jordan, Utah, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Skin Sciences, PLLC
🇺🇸Louisville, Kentucky, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Tulane Univ School of Med
🇺🇸New Orleans, Louisiana, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States