A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

• Status: Not yet recruiting
• Trial end date: 2023-12-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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