a study of lebrikizumab (ly3650150) on vaccine response in adults with atopic dermatitis (adopt-va)

Conditions: Atopic Dermatitis

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).


Eligibility 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.

Keywords: eczema skin diseases