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

Lilly

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Lebrikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04626297

2020-002572-12 (EudraCT Number)

17946

J2T-MC-KGAK (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 254 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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254 participants in 2 patient groups, including a placebo group

Lebrikizumab

Experimental group

Description:

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.

Treatment:

Drug: Lebrikizumab

Placebo

Placebo Comparator group

Description:

Participants received placebo SC injection Q2W from baseline to week 14.

Treatment:

Drug: Placebo