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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.

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

Details

• Lead Sponsor: Almirall, S.A.
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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 3 (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

• 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

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

• Presence of skin comorbidities that may interfere with study assessments

• Have had an important side effect to TCS that would prevent further use.