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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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).

Key facts

Study ID: NCT04626297
Run by: Eli Lilly and Company
People needed: 254
Starts: 2020-11-17
Expected to finish: 2022-09-30
Last updated by the study team: 2023-10-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
Arkansas Research Trials — North Little Rock, Arkansas, United States
Orange County Research Institute — Anaheim, California, United States
Wallace Medical Group, Inc. — Beverly Hills, California, United States
First OC Dermatology — Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc. — Fremont, California, United States
Axon Clinical Research — Inglewood, California, United States
Sunwise Clinical Research — Lafayette, California, United States
Avance Trials — Laguna Niguel, California, United States
Keck School of Medicine University of Southern California — Los Angeles, California, United States
Dermatology Research Associates — Los Angeles, California, United States
LA Universal Research Center, INC — Los Angeles, California, United States
Ablon Skin Institute and Research Center — Manhattan Beach, California, United States
Dermatology Clinical Trials — Newport Beach, California, United States
Cura Clinical Research — Palmdale, California, United States
MD Strategies Research Centers MDSRC — San Diego, California, United States
University Clinical Trials — San Diego, California, United States
Synergy Dermatology — San Francisco, California, United States
Care Access Research — San Jose, California, United States
San Luis Dermatology & Laser Clinic — San Luis Obispo, California, United States
Southern California Dermatology, Inc. — Santa Ana, California, United States
IMMUNOe International Research Centers — Centennial, Colorado, United States
Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States
Florida Academic Centers Research and Education, LLC — Coral Gables, Florida, United States
Clinical Research Center of Alabama- Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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