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 : April 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Lebrikizumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||August 19, 2022|
|Estimated Study Completion Date :||October 28, 2022|
Lebrikizumab given by subcutaneous (SC) injection.
Placebo Comparator: Placebo
Placebo given by SC injection.
- 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
- 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).
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
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||Clinicaltrials.email@example.com|
|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|