A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.

Key facts

Study ID: NCT02104674
Run by: Hoffmann-La Roche
People needed: 313
Starts: 2014-06-07
Expected to finish: 2016-01-22
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18-75 years old at study start
Asthma diagnosis for >/= 12 months prior to study start
Bronchodilator response at screening
Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3
No other clinically significant lung disease as confirmed by chest X-ray or computed tomography (CT) scan
Stable and symptomatic asthma during the screening period
Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose

You may not qualify if…

Maintenance of corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start
Treatment with systemic or inhaled corticosteroids within 4 weeks prior to study start or during the screening period for any reason, including an acute exacerbation event
Treatment with a leukotriene receptor antagonist (LTRA), long-acting beta-agonist (LABA) long-acting muscarinic antagonist (LAMA), zileuton, roflumilast, or theophylline within 2 weeks prior to study start
Documented prior treatment failure with Montelukast
Treatment with intra-articular corticosteroids within 4 weeks prior to study start or during the screening period or anticipated need for intra articular corticosteroids during the course of the study
Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start. Any infection requiring oral antibiotic treatment within 2 weeks of study start, or any parasitic infection within 6 months of study start
Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study, or impact the study assessments
History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
History of alcohol or drug abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator
Current or history of smoking (> 10 pack-years), or unwillingness to abstain from smoking for the duration of the study
Past and/or current use of any anti-IL-13 or anti- IL4/IL-13 therapy, including lebrikizumab
Use of a licensed or investigational monoclonal antibody other than anti IL-13 or anti-IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to study start or during screening
Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening
Initiation of or change in allergen immunotherapy within 3 months prior to study start or during screening
Receipt of a live attenuated vaccine within 4 weeks prior to study start of during screening
Pregnancy or breast feeding
Body mass index > 38 kg/m2
Body weight < 40 kg
History of bronchial thermoplasty

Where it is running

Allergy & Asthma Immunology Associates — Scottsdale, Arizona, United States
Anaheim Clinical Trials — Anaheim, California, United States
CA Allergy & Asthma Med Grp; Medical Group, Inc. — Los Angeles, California, United States
Southern California Institute For Respiratory — Los Angeles, California, United States
North Bay Clinical Trials — Napa, California, United States
Advances in Medicine — Rancho Mirage, California, United States
Allergy & Asthma Consultants — Redwood City, California, United States
Integrated Research Group Inc — Riverside, California, United States
Storms Clinical Research; Institute — Colorado Springs, Colorado, United States
National Jewish Health — Denver, Colorado, United States
Florida Pulmonary Research Institute, LLC — Winter Park, Florida, United States
In-Quest Medical Research, LLC — Duluth, Georgia, United States
Sneeze, Wheeze, & Itch Associates — Normal, Illinois, United States
Asthma & Allergy Center of Chicago, S.C. — River Forest, Illinois, United States
Family Allergy & Asthma — Louisville, Kentucky, United States
Midwest Clinical Research LLC — St Louis, Missouri, United States
The Clinical Research Ctr — St Louis, Missouri, United States
Asthma & Allergy Center, P.C. — Papillion, Nebraska, United States
Advanced Research Institute — Reno, Nevada, United States
Atlantic Research Center, LLC — Ocean City, New Jersey, United States
Urban Health Plan, Inc. — The Bronx, New York, United States
Allergy, Asthma & Clinical Research Center — Oklahoma City, Oklahoma, United States
Clinical Research Inst. of Southern Oregon, Pc — Medford, Oregon, United States
Allergy Associates Research Center LLC - CRN — Portland, Oregon, United States
Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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