A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Lebrikizumab in Adolescent Patients with Uncontrolled Asthma who are on Inhaled Corticosteroids and a Second Controller Medication (IRB# 43985)
- Principal Investigator: Adam Spanier, MD, PhD, MPH
The burden of asthma is high in the pediatric population. Uncontrolled asthma, in particular, accounts for a major proportion of the overall burden of asthma. Even with guidelines-based asthma therapy (NHLBI 2007), asthma in up to 50% of asthma patients is not well controlled. The evidence indicates that severe asthma is not a uniform condition and that phenotypic variability is a key aspect of the disease.
Lebrikizumab is being developed for the treatment of patients with uncontrolled asthma despite treatment with a combination of inhaled corticosteroid (ICS) therapy and a second asthma controller medication. The proposed clinical development program for lebrikizumab will evaluate whether specific modulation of a type 2 helper T cell immune pathway that is mediated by interleukin-13 will improve clinical outcomes in patients with asthma whose disease remains uncontrolled by standard guideline-based therapies.
Inclusion criteria includes:
1) Adolescent between 12-17 years of age at all three screening visits.
2) Asthma diagnosis at least 12 months prior to the first screening visit.
3) A bronchodilator response less than or equal to 12% FEV1 improvement at all screening visits.
4) A pre-bronchodilator FEV1 between 40%-90% predicted at the second and third screening visits.
5) Inhaled corticosteroids or ICS therapy at a daily dose of 500-2000 µg of fluticasone propionate DPI or equivalent 6 months or more prior to the first home visit, no changes should be made within 4 weeks of the first home visit and no changes should be anticipated.
6) Adolescent must be on a second controller medication such as LABAs, LTRAs, LAMAs, or theophylline for 6 months prior to the first visits with no changes 4 weeks prior to the first visits and no anticipated changes.
7) Uncontrolled asthma defined as a ACQ-5 score and at least one of these guidelines (symptoms of asthma more than 2 days in a week, night-time awakening more than 1 time per week, use of SABA rescue medication more than 2 days in a week, or interference with normal daily activity).
8) Adolescent showing 70% adherence to their asthma controller therapy during the screening process.
Additional Study Details:
We will recruit participants from the Penn State Milton S. Hershey Medical Center via physician or nurse referral.
Penn State Milton S. Hershey Medical Center
Pediatrics at 35 Hope Drive
Pediatric Clinical Research Office