An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
Inclusion Criteria:
Exclusion Criteria:
Participation in a prior lebrikizumab clinical study.
Treatment with the following prior to the baseline visit:
Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
Uncontrolled chronic disease that might require bursts of oral corticosteroids.
Evidence of active acute or chronic hepatitis
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
San Diego, California 92123, United States
Iwonicz-Zdrój, Podkarpackie Voivodeship 38-440, Poland
Lodz, Łódź Voivodeship 90-436, Poland