Overview

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

Status:
Recruiting
Trial end date:
2022-01-14
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
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.