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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04626297
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 6, 2020
First Posted Date  ICMJE November 12, 2020
Last Update Posted Date January 19, 2022
Actual Study Start Date  ICMJE November 17, 2020
Estimated Primary Completion Date August 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
  • Percentage of Participants who Develop a Booster Response to Tetanus Toxoid 4 Weeks after Vaccine Administration [ Time Frame: Week 16 ]
    Booster response 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 MCV (Group C Serum Bactericidal Antibodies) 4 Weeks after Vaccine Administration [ Time Frame: Week 16 ]
    Positive antibody response to Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (GlaxoSmithKline) (MCV) is defined as: post-vaccination human complement serum bactericidal assay (hSBA) titer ≥4 times the lower limit of quantitation (LLOQ), if the pre-vaccination hSBA titer is less than the LLOQ; OR post-vaccination hSBA titer ≥4 times the pre-vaccination titer, if the prevaccination hSBA titer is greater than or equal to the LLOQ
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
  • Percentage of Participants Achieving an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction of ≥2 Points from Baseline [ Time Frame: 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.
  • Percentage of Participants Achieving a ≥75% Reduction from Baseline in Eczema Area and Severity Index Score (EASI-75) [ Time Frame: Week 16 ]
    The EASI-75 is defined as a ≥ 75% improvement from baseline in the EASI score and ranges from 0 - 72 (severe).
  • Percentage of Participants Achieving EASI-90 [ Time Frame: Week 16 ]
    The EASI-90 is defined as a ≥ 90% improvement from baseline in the EASI score and ranges from 0 - 72 (severe).
  • Percentage of Participants Achieving ≥4-Point Improvement from Baseline in Pruritus Numeric Rating Scale (NRS) Score [ Time Frame: Week 16 ]
    Participants will assess pruritus using a Pruritus NRS. 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."
  • Change from Baseline in Percent Body Surface Area (BSA) [ Time Frame: 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 total body surface.
  • Change from Baseline in Sleep-Loss Score [ Time Frame: Baseline, Week 16 ]
    Participants will assess their Sleep-Loss due to pruritus. They will rate their sleep based on a 5-point Likert scale: 0 (not at all) to 4 (unable to sleep at all).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Lebrikizumab
    Given SC
    Other Names:
    • LY3650150
    • DRM06
  • Drug: Placebo
    Given SC
Study Arms  ICMJE
  • Experimental: Lebrikizumab
    Lebrikizumab given by subcutaneous (SC) injection.
    Intervention: Drug: Lebrikizumab
  • Placebo Comparator: Placebo
    Placebo given by SC injection.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2020)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 28, 2022
Estimated Primary Completion Date August 19, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04626297
Other Study ID Numbers  ICMJE 17946
J2T-MC-KGAK ( Other Identifier: Eli Lilly and Company )
2020-002572-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (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.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date January 2, 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP