Psoriasis Clinical Trial
A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
Summary
The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.
Eligibility Criteria
Inclusion Criteria:
All participants must have prior treatment with dupilumab meeting one of the following conditions:
Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months.
Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.
Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.
Participants who have chronic AD that has been present for ≥1 year before screening.
Have EASI ≥16 at baseline
Have IGA score ≥3 (Scale of 0 to 4) at baseline
Have ≥10% body surface area (BSA) of AD involvement at baseline
Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
Adolescents body weight must be ≥40 kg at baseline.
Exclusion Criteria:
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA
Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA
Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.
Have uncontrolled asthma that
might require bursts of oral or systemic corticosteroids, or
required the following due to ≥1 exacerbations within 12 months before baseline
systemic (oral and/or parenteral) corticosteroid treatment, or
hospitalization for >24 hours.
Have known liver cirrhosis and/or chronic hepatitis of any etiology.
Had Dupilumab treatment within 4 weeks prior to baseline
Had prior treatment with tralokinumab.
Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline
Treatment with any of the following agents within 4 weeks prior to the baseline
systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)
small molecules (e.g. JAK inhibitors)
phototherapy and photochemotherapy for AD
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There are 48 Locations for this study
Birmingham Alabama, 35205, United States More Info
Principal Investigator
Montgomery Alabama, 36117, United States More Info
Principal Investigator
Phoenix Arizona, 85006, United States More Info
Principal Investigator
Fountain Valley California, 92708, United States More Info
Principal Investigator
Fremont California, 94538, United States More Info
Principal Investigator
Inglewood California, 90301, United States More Info
Principal Investigator
Laguna Niguel California, 92677, United States More Info
Principal Investigator
Los Angeles California, 90045, United States More Info
Principal Investigator
Los Angeles California, 90056, United States More Info
Principal Investigator
Santa Monica California, 90404, United States More Info
Principal Investigator
Sherman Oaks California, 91403, United States More Info
Principal Investigator
Boca Raton Florida, 33486, United States More Info
Principal Investigator
Boynton Beach Florida, 33436, United States More Info
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Boynton Beach Florida, 33437, United States More Info
Principal Investigator
Brooksville Florida, 34613, United States More Info
Principal Investigator
Hialeah Florida, 33012, United States More Info
Principal Investigator
Hollywood Florida, 33021, United States More Info
Principal Investigator
Lake Worth Florida, 33461, United States More Info
Principal Investigator
Miami Lakes Florida, 33014, United States More Info
Principal Investigator
Miami Florida, 33173, United States More Info
Principal Investigator
Miami Florida, 33173, United States More Info
Principal Investigator
Tampa Florida, 33614, United States More Info
Principal Investigator
West Palm Beach Florida, 33401, United States More Info
Principal Investigator
Macon Georgia, 31217, United States More Info
Principal Investigator
Marietta Georgia, 30060, United States More Info
Principal Investigator
Sandy Springs Georgia, 30328, United States More Info
Principal Investigator
Chicago Illinois, 60611, United States More Info
Principal Investigator
Skokie Illinois, 60077, United States More Info
Principal Investigator
West Dundee Illinois, 60118, United States More Info
Principal Investigator
Indianapolis Indiana, 46250, United States More Info
Principal Investigator
Lake Charles Louisiana, 70605, United States More Info
Principal Investigator
New Orleans Louisiana, 70115, United States More Info
Principal Investigator
Rockville Maryland, 20850, United States More Info
Principal Investigator
Beverly Massachusetts, 01915, United States More Info
Principal Investigator
Auburn Hills Michigan, 48326, United States More Info
Principal Investigator
Bay City Michigan, 48706, United States More Info
Principal Investigator
Caledonia Michigan, 49316, United States More Info
Principal Investigator
Troy Michigan, 48084, United States More Info
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Saint Joseph Missouri, 64506, United States More Info
Principal Investigator
Omaha Nebraska, 68144, United States More Info
Principal Investigator
East Windsor New Jersey, 08520, United States More Info
Principal Investigator
Fairport New York, 14450, United States More Info
Principal Investigator
New York New York, 10075, United States More Info
Principal Investigator
New York New York, 10128, United States More Info
Principal Investigator
Johnston Rhode Island, 02919, United States More Info
Principal Investigator
Arlington Texas, 76011, United States More Info
Principal Investigator
Sugar Land Texas, 77479, United States More Info
Principal Investigator
Spokane Washington, 99202, United States More Info
Principal Investigator
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