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

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ClinicalTrials.gov Identifier: NCT04626297
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Lebrikizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : September 20, 2022
Estimated Study Completion Date : November 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Lebrikizumab
Lebrikizumab given by subcutaneous (SC) injection.
Drug: Lebrikizumab
Given SC
Other Names:
  • LY3650150
  • DRM06

Placebo Comparator: Placebo
Placebo given by SC injection.
Drug: Placebo
Given SC




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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."

  5. 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.

  6. 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).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626297


Contacts
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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

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04626297    
Other Study ID Numbers: 17946
J2T-MC-KGAK ( Other Identifier: Eli Lilly and Company )
2020-002572-12 ( EudraCT Number )
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Eczema
Skin Diseases
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases