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

Purpose

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

  • Atopic Dermatitis

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
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. - 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
Eli Lilly and Company

Study Contact