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

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).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Lebrikizumab

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Clinical Research Center of Alabama- Birmingham
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials
  • California
    • Anaheim, California, United States, 92801
      • Orange County Research Institute
    • Beverly Hills, California, United States, 90211
      • Wallace Medical Group, Inc.
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, Inc.
    • Inglewood, California, United States, 90301
      • Axon Clinical Research
    • Lafayette, California, United States, 94549
      • Sunwise Clinical Research
    • Laguna Niguel, California, United States, 92677
      • Avance Trials
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine University of Southern California
    • Los Angeles, California, United States, 90057
      • LA Universal Research Center, INC
    • Manhattan Beach, California, United States, 90266
      • Ablon Skin Institute and Research Center
    • Newport Beach, California, United States, 92660
      • Dermatology Clinical Trials
    • Palmdale, California, United States, 93551
      • Cura Clinical Research
    • San Diego, California, United States, 92119
      • MD Strategies Research Centers MDSRC
    • San Diego, California, United States, 92123
      • University Clinical Trials
    • San Francisco, California, United States, 94132
      • Synergy Dermatology
    • San Jose, California, United States, 95117
      • Care Access Research
    • San Luis Obispo, California, United States, 93405
      • San Luis Dermatology & Laser Clinic
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology, Inc.
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe International Research Centers
    • Colorado Springs, Colorado, United States, 80907-6231
      • Asthma and Allergy Associates, PC
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research and Education, LLC
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Hialeah, Florida, United States, 33016
      • The Community Research of South Florida
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research
    • Kendall, Florida, United States, 33183
      • C&R Research Services USA
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • Miami, Florida, United States, 33157
      • Sanchez Clinical Research Inc
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Research
    • Miami, Florida, United States, 33174
      • Florida Research Center, Inc
    • Miami Lakes, Florida, United States, 33016
      • Wellness Clinical Research
    • Pembroke Pines, Florida, United States, 33028
      • Riverchase Dermatology and Cosmetic Surgery
    • Tampa, Florida, United States, 33614
      • Olympian Clinical Research
    • Tampa, Florida, United States, 33613-1244
      • Forcare Clinical Research
    • Tampa, Florida, United States, 33612
      • Tampa General Hospital
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research
    • Savannah, Georgia, United States, 31419
      • Georgia Skin & Cancer Clinic
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, & Itch Associates LLC
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Kansas City Dermatology, PA
    • Shawnee Mission, Kansas, United States, 66216
      • Kansas Medical Clinic, an Elligo Health Research, Inc.
    • Topeka, Kansas, United States, 66614
      • Kansas Medical Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Skin Sciences, Pllc
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Univ School of Med
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Dermatology
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medisearch Clinical Trials
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Advanced Dermatology of the Midlands
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
  • New York
    • New York, New York, United States, 10022-3350
      • Juva Skin & Laser Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, PC
    • Tulsa, Oklahoma, United States, 74136
      • Central States Research
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • Peak Research LLC
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
    • Warwick, Rhode Island, United States, 02886
      • AAPRI Clinical Research Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
    • Dallas, Texas, United States, 75231
      • Modern Research Associates
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center
    • Dripping Springs, Texas, United States, 78620
      • Austin Institute for Clinical Research
    • Houston, Texas, United States, 77004
      • Center For Clinical Studies
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, PA
    • Laredo, Texas, United States, 78041
      • Laredo Dermatology Associates P.A.
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
    • Webster, Texas, United States, 77598
      • Center For Clinical Studies
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Velocity Clinical Research - Woseth Dermatology
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology Center
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Lebrikizumab; Given SC; Other Names: LY3650150; DRM06
Placebo Comparator: Placebo; Participants received placebo SC injection Q2W from baseline to week 14.	Drug: Placebo; Given SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction of ≥2 Points From Baseline	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.	Week 16
Percentage of Participants Achieving a ≥75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-75)	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.	Week 16
Percentage of Participants Achieving ≥90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-90)	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.	Week 16
Percentage of Participants Achieving ≥4-Point Improvement From Baseline in Pruritus Numeric Rating Scale (NRS) Score	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.	Week 16
Change From Baseline in Percent Body Surface Area (BSA)	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.	Baseline, Week 16
Change From Baseline in Sleep-Loss Score	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.	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Publications and helpful links

Helpful Links

• A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): August 3, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Eczema; Skin Diseases
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 17946; J2T-MC-KGAK (Other Identifier: Eli Lilly and Company); 2020-002572-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No