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

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    240
  • sponsor
    Eli Lilly and Company
Updated on 10 October 2021
eczema
lebrikizumab
topical agents

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).

Details
Condition Eczema, ATOPIC DERMATITIS, Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Eczéma (Dermatite Atopique), Dermatite Atopique
Treatment Placebo, Lebrikizumab
Clinical Study IdentifierNCT04626297
SponsorEli Lilly and Company
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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
% 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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