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.