Psoriasis Clinical Trial
A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
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).
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.
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.
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There are 83 Locations for this study
Birmingham Alabama, 35244, United States
Hot Springs Arkansas, 71913, United States
North Little Rock Arkansas, 72117, United States
Anaheim California, 92801, United States
Beverly Hills California, 90211, United States
Fountain Valley California, 92708, United States
Fremont California, 94538, United States
Inglewood California, 90301, United States
Lafayette California, 94549, United States
Laguna Niguel California, 92677, United States
Los Angeles California, 90033, United States
Los Angeles California, 90045, United States
Los Angeles California, 90057, United States
Manhattan Beach California, 90266, United States
Newport Beach California, 92660, United States
Palmdale California, 93551, United States
San Diego California, 92119, United States
San Diego California, 92123, United States
San Francisco California, 94132, United States
San Jose California, 95117, United States
San Luis Obispo California, 93405, United States
Santa Ana California, 92701, United States
Centennial Colorado, 80112, United States
Colorado Springs Colorado, 80907, United States
Coral Gables Florida, 33134, United States
Hialeah Florida, 33012, United States
Hialeah Florida, 33016, United States
Jacksonville Florida, 32256, United States
Kendall Florida, 33183, United States
Miami Lakes Florida, 33016, United States
Miami Florida, 33144, United States
Miami Florida, 33157, United States
Miami Florida, 33165, United States
Miami Florida, 33173, United States
Miami Florida, 33174, United States
Pembroke Pines Florida, 33028, United States
Tampa Florida, 33612, United States
Tampa Florida, 33613, United States
Tampa Florida, 33614, United States
Sandy Springs Georgia, 30328, United States
Savannah Georgia, 31419, United States
Normal Illinois, 61761, United States
West Dundee Illinois, 60118, United States
Plainfield Indiana, 46168, United States
Overland Park Kansas, 66215, United States
Shawnee Mission Kansas, 66216, United States
Topeka Kansas, 66614, United States
Louisville Kentucky, 40217, United States
New Orleans Louisiana, 70112, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02115, United States
Brighton Massachusetts, 02135, United States
Auburn Hills Michigan, 48326, United States
Warren Michigan, 48088, United States
Saint Joseph Missouri, 64506, United States
Omaha Nebraska, 68144, United States
East Windsor New Jersey, 08520, United States
Hackensack New Jersey, 07601, United States
New York New York, 10022, United States
Cleveland Ohio, 44106, United States
Dayton Ohio, 45414, United States
Oklahoma City Oklahoma, 73118, United States
Tulsa Oklahoma, 74136, United States
Tulsa Oklahoma, 74136, United States
Portland Oregon, 97223, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Upper Saint Clair Pennsylvania, 15241, United States
Johnston Rhode Island, 02919, United States
Warwick Rhode Island, 02886, United States
Charleston South Carolina, 29425, United States
Arlington Texas, 76011, United States
Bellaire Texas, 77401, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Dripping Springs Texas, 78620, United States
Houston Texas, 77004, United States
Houston Texas, 77056, United States
Laredo Texas, 78041, United States
San Antonio Texas, 78213, United States
San Antonio Texas, 78218, United States
Webster Texas, 77598, United States
Salt Lake City Utah, 84117, United States
South Jordan Utah, 84095, United States
Spokane Washington, 99202, United States
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