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

STATUS

Recruiting
End date

Oct 28, 2022
participants needed

240
sponsor

Eli Lilly and Company

Updated on 2 May 2022

See if I qualify

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	Atopic Dermatitis
Treatment	Placebo, Lebrikizumab
Clinical Study Identifier	NCT04626297
Sponsor	Eli Lilly and Company
Last Modified on	2 May 2022

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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
	≥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
	A contraindication to the Tdap vaccine or mean corpuscular volume (MCV)
	screening, or treated with a live (attenuated) vaccine within 12 weeks of the
	Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
	baseline visit or planned during the study

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Step 4 Get your study results

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