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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04626297
Collaborator
(none)
240
Enrollment
85
Locations
2
Arms
22.8
Anticipated Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 17, 2020
Actual Primary Completion Date :
Aug 3, 2022
Anticipated Study Completion Date :
Oct 12, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants who Develop a Booster Response to Tetanus Toxoid 4 Weeks after Vaccine Administration [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 [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 [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) [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 [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 [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) [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 [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

      1. 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.
      1. 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:

      1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer
      1. B Cell-depleting biologics, including rituximab, within 6 months
      1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Center of Alabama- Birmingham Birmingham Alabama United States 35244
    2 Burke Pharmaceutical Research Hot Springs Arkansas United States 71913
    3 Arkansas Research Trials North Little Rock Arkansas United States 72117
    4 Orange County Research Institute Anaheim California United States 92801
    5 Wallace Medical Group, Inc. Beverly Hills California United States 90211
    6 First OC Dermatology Fountain Valley California United States 92708
    7 Center For Dermatology Clinical Research, Inc. Fremont California United States 94538
    8 Axon Clinical Research Inglewood California United States 90301
    9 Sunwise Clinical Research Lafayette California United States 94549
    10 Avance Trials Laguna Niguel California United States 92677
    11 Keck School of Medicine University of Southern California Los Angeles California United States 90033
    12 Dermatology Research Associates Los Angeles California United States 90045
    13 LA Universal Research Center, INC Los Angeles California United States 90057
    14 Ablon Skin Institute and Research Center Manhattan Beach California United States 90266
    15 Dermatology Clinical Trials Newport Beach California United States 92660
    16 Cura Clinical Research Palmdale California United States 93551
    17 MD Strategies Research Centers MDSRC San Diego California United States 92119
    18 University Clinical Trials San Diego California United States 92123
    19 Synergy Dermatology San Francisco California United States 94132
    20 Care Access Research San Jose California United States 95117
    21 San Luis Dermatology & Laser Clinic San Luis Obispo California United States 93405
    22 Southern California Dermatology, Inc. Santa Ana California United States 92701
    23 IMMUNOe International Research Centers Centennial Colorado United States 80112
    24 Asthma and Allergy Associates, PC Colorado Springs Colorado United States 80907-6231
    25 Florida Academic Centers Research and Education, LLC Coral Gables Florida United States 33134
    26 Direct Helpers Research Center Hialeah Florida United States 33012
    27 The Community Research of South Florida Hialeah Florida United States 33016
    28 Solutions Through Advanced Research Jacksonville Florida United States 32256
    29 C&R Research Services USA Kendall Florida United States 33183
    30 Wellness Clinical Research Miami Lakes Florida United States 33016
    31 International Dermatology Research, Inc. Miami Florida United States 33144
    32 Sanchez Clinical Research Inc Miami Florida United States 33157
    33 New Horizon Research Center Miami Florida United States 33165
    34 Miami Dermatology and Laser Research Miami Florida United States 33173
    35 Florida Research Center, Inc Miami Florida United States 33174
    36 Riverchase Dermatology and Cosmetic Surgery Pembroke Pines Florida United States 33028
    37 Tampa General Hospital Tampa Florida United States 33612
    38 ForCare Clinical Research Tampa Florida United States 33613-1244
    39 Olympian Clinical Research Tampa Florida United States 33614
    40 Advanced Medical Research Sandy Springs Georgia United States 30328
    41 Georgia Skin & Cancer Clinic Savannah Georgia United States 31419
    42 Sneeze, Wheeze, & Itch Associates LLC Normal Illinois United States 61761
    43 Dundee Dermatology West Dundee Illinois United States 60118
    44 The Indiana Clinical Trials Center Plainfield Indiana United States 46168
    45 Kansas City Dermatology, PA Overland Park Kansas United States 66215
    46 Kansas Medical Clinic, an Elligo Health Research, Inc. Shawnee Mission Kansas United States 66216
    47 Kansas Medical Clinic Topeka Kansas United States 66614
    48 Skin Sciences, PLLC Louisville Kentucky United States 40217
    49 Tulane Univ School of Med New Orleans Louisiana United States 70112
    50 Tufts Medical Center Boston Massachusetts United States 02111
    51 Brigham and Women's Hospital Boston Massachusetts United States 02115
    52 Metro Boston Clinical Partners Brighton Massachusetts United States 02135
    53 Oakland Dermatology Auburn Hills Michigan United States 48326
    54 Grekin Skin Institute Warren Michigan United States 48088
    55 MediSearch Clinical Trials Saint Joseph Missouri United States 64506
    56 Advanced Dermatology of the Midlands Omaha Nebraska United States 68144
    57 Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey United States 08520
    58 Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology Hackensack New Jersey United States 07601
    59 JUVA Skin & Laser Center New York New York United States 10022-3350
    60 University Hospitals Case Medical Center Cleveland Ohio United States 44106
    61 Ohio Pediatric Research Association Dayton Ohio United States 45414
    62 Unity Clinical Research Oklahoma City Oklahoma United States 73118
    63 Central States Research Tulsa Oklahoma United States 74136
    64 Vital Prospects Clinical Research Institute, PC Tulsa Oklahoma United States 74136
    65 Oregon Medical Research Center Portland Oregon United States 97223
    66 University of Pennsylvania Hospital Philadelphia Pennsylvania United States 19104
    67 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    68 Peak Research LLC Upper Saint Clair Pennsylvania United States 15241
    69 Clinical Partners, LLC Johnston Rhode Island United States 02919
    70 AAPRI Clinical Research Institute Warwick Rhode Island United States 02886
    71 Medical University of South Carolina Charleston South Carolina United States 29425
    72 Arlington Research Center, Inc Arlington Texas United States 76011
    73 Bellaire Dermatology Associates Bellaire Texas United States 77401
    74 Dermatology Treatment and Research Center Dallas Texas United States 75230
    75 Modern Research Associates Dallas Texas United States 75231
    76 Austin Institute for Clinical Research Dripping Springs Texas United States 78620
    77 Center for Clinical Studies Houston Texas United States 77004
    78 Suzanne Bruce and Associates, PA Houston Texas United States 77056
    79 Laredo Dermatology Associates P.A. Laredo Texas United States 78041
    80 Progressive Clinical Research San Antonio Texas United States 78213
    81 Texas Dermatology and Laser Specialists San Antonio Texas United States 78218
    82 Center for Clinical Studies Webster Texas United States 77598
    83 Velocity Clinical Research - Woseth Dermatology Salt Lake City Utah United States 84117
    84 Jordan Valley Dermatology Center South Jordan Utah United States 84095
    85 Premier Clinical Research Spokane Washington United States 99202

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04626297
    Other Study ID Numbers:
    • 17946
    • J2T-MC-KGAK
    • 2020-002572-12
    First Posted:
    Nov 12, 2020
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Aug 19, 2022