Asthma, Adolescent
THIS TRIAL IS NOW CLOSED
A Study of Lebrikizumab in Adolescent Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Investigator: Adam Williams, MD
Status: Recruiting
Phase: 3
Sponsor: Hoffmann-La Roche
Contact: Lisa Baert, 541-706-6590 or lbaert@bmctotalcare.com
Location: Bend, Oregon (Central Oregon)
Purpose: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of lebrikizumab in adolescent patients with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid therapy and at least one second controller medication. Patients will be randomized 1:1:1 to receive double-blind treatment with either lebrikizumab (“high” or “low”) or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment up to 104 weeks. After study treatment, all patients will complete a 20 week safety follow-up.
Inclusion Criteria:
- Adolescent patients, 12 – 17 years of age at the time of screening and randomization
- Asthma diagnosis for >/= 12 months at Visit 1
- Bronchodilator response during screening
- Pre-bronchodilator FEV1 of 40% – 90% predicted at both Visits 2 and 3
- On high dose inhaled corticosteroid (ICS) therapy for >/= 6 months prior to Visit 1
- On an eligible second controller medication for 6 months prior to Visit 1
- Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization
- Demonstrated adherence with controller medication during the screening period
Exclusion Criteria:
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Maintenance oral corticosteroid therapy within 3 months of Visit 1
- Treatment with systemic (oral, intravenous, or intramuscular) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
- Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
- Infection that meets the following criteria:
- Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening:
- Any active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening; Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening;
- History of active tuberculosis requiring treatment
- Known immunodeficiency, including, but not limited to, HIV infection
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma
- Diagnosis or history of malignancy or current evaluation for potential malignancy
- Current smoker or former smoker with a history of > 10 pack-years
- History of alcohol or drug abuse
- Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1
- Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
See this trial at ClinicalTrials.gov
For general inquiries, please contact the BMC Research Department at research@bmctotalcare.com or 877-692-8338.