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 36 Locations for this study
Montgomery Alabama, 36117, United States
Phoenix Arizona, 85006, United States
Fountain Valley California, 92708, United States
Inglewood California, 90301, United States
Laguna Niguel California, 92677, United States
Los Angeles California, 90045, United States
Los Angeles California, 90056, United States
Santa Monica California, 90404, United States
Sherman Oaks California, 91403, United States
Farmington Connecticut, 06030, United States
Boynton Beach Florida, 33436, United States
Boynton Beach Florida, 33437, United States
Hialeah Florida, 33012, United States
Hollywood Florida, 33021, United States
Miami Florida, 33173, United States
North Miami Beach Florida, 33162, United States
Tampa Florida, 33614, United States
Macon Georgia, 31217, United States
Sandy Springs Georgia, 30328, United States
West Dundee Illinois, 60118, United States
Indianapolis Indiana, 46250, United States
Lake Charles Louisiana, 70605, United States
Rockville Maryland, 20850, United States
Beverly Massachusetts, 01915, United States
Auburn Hills Michigan, 48326, United States
Caledonia Michigan, 49316, United States
Troy Michigan, 48084, United States
Saint Joseph Missouri, 64506, United States
Portsmouth New Hampshire, 03801, United States
East Windsor New Jersey, 08520, United States
New York New York, 10075, United States
New York New York, 10128, United States
Bexley Ohio, 43209, United States
Johnston Rhode Island, 02919, United States
Sugar Land Texas, 77479, United States
Spokane Washington, 99202, United States
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