A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine

Korábbi kezelés

• Treatment with TCS within 1 week before the Baseline visit.
• Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit.
• Treatment with interleukin 4 (IL-4) or interleukin 13 (IL-13) antagonists biological therapies before the Baseline visit. Exception: previous treatment with dupilumab will be allowed in a subset of patients
• Treatment with immunosuppressive/immunomodulating drugs, phototherapy and photochemotherapy within 4 weeks before the Baseline visit

Más betegség

• Uncontrolled chronic disease that might require bursts of oral corticosteroids
• Serious, opportunistic, chronic or recurring infections within 3 months of Screening or before randomization
• Current or chronic infection with hepatitis B virus, current infection with hepatitis C virus, known liver cirrhosis and/or chronic hepatitis of any etiology
• Known or suspected history of immunosuppression, history of HIV infection or positive HIV serology at Screening

Laborértékek

• Any clinically significant laboratory test results obtained at the Screening visit

Egyéb

• Presence of skin comorbidities that may interfere with study assessments
• Have had an important side effect to TCS that would prevent further use.

• Adults and adolescents (aged greater than or equal to (>=) 12 to <18 years at the time of Informed Consent Form (ICF)/Informed Assent Form (IAF) and weighing >=40 kilograms).
• Chronic AD that has been present for >=1 year before the Screening visit.
• EASI score >=16 at the Baseline Visit.
• IGA score >=3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Baseline visit.
• >=10% BSA of AD involvement at the Baseline visit.
• Inadequate response to existing topical medications
• Failure to cyclosporine or non-medically advisable to receive/continue receiving cyclosporine
• Signed ICF (and informed assent for adolescents as required)