A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio 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. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

Key facts

Study ID: NCT01867125
Run by: Hoffmann-La Roche
People needed: 1081
Starts: 2013-07-25
Expected to finish: 2016-12-28
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…

Asthma diagnosis for greater than equal to (>/=) 12 months prior to Visit 1
Bronchodilator response at Visit 1, 2, or 3
Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
On ICS therapy at a total daily dose of 500-2000 micrograms (mcg) of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/=6 months prior to Visit 1
On an eligible second controller medication (long-acting beta-agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], or theophylline) for 6 months prior to Visit 1
Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3
Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) confirming the absence of other clinically significant lung disease
Demonstrated adherence with controller medication during the screening period

You may not qualify if…

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 [IV], or intramuscular [IM]) 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 requiring hospital admission for >/=24 hours or requiring treatment with IV or IM antibiotics within 4 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 infection that required treatment with oral antibiotics within 2 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
Active tuberculosis requiring treatment within 12 months prior to Visit 1
Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
Evidence of acute or chronic hepatitis or known liver cirrhosis
History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
Known current malignancy or current evaluation for potential malignancy
Current smoker or former smoker with a history of greater than (>) 10 pack-years
History of alcohol or drug abuse
Past and/or current use of any anti-interleukin (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 prior to Visit 1 (whichever is longer) or during screening
Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening

Where it is running

Desert Sun Clinical Research LLC — Tucson, Arizona, United States
Allianz Medical and Research Center — Fountain Valley, California, United States
Allergy & Asthma Medical Group & Research Center, Pc — Long Beach, California, United States
Allergy Medical Clinic — Los Angeles, California, United States
CA Allergy & Asthma Med Grp — Los Angeles, California, United States
North Bay Clinical Trials — Napa, California, United States
Choc Psf, Amc — Orange, California, United States
Advances in Medicine — Rancho Mirage, California, United States
Allergy Assoc Medical Group — San Diego, California, United States
Bensch Research Associates — Stockton, California, United States
IMMUNOe Research Centers — Centennial, Colorado, United States
Waterbury Pulmonary Associates — Waterbury, Connecticut, United States
St. Francis Sleep; Allergy & Lung Institute — Clearwater, Florida, United States
Suncoast Research Group LLC — Miami, Florida, United States
Emerald Coast Research Associates — Panama City, Florida, United States
Allergy & Asthma Diagnostic; Treatment Center — Tallahassee, Florida, United States
Florida Pulmonary Research Institute, LLC — Winter Park, Florida, United States
Atlanta Allergy & Asthma Clini — Woodstock, Georgia, United States
Northeast Medical Research Associates, Inc — North Dartmouth, Massachusetts, United States
Midwest Clinical Research LLC — St Louis, Missouri, United States
Montana Medical Research LLC — Missoula, Montana, United States
Heartland Clinical Research Inc. — Omaha, Nebraska, United States
Asthma & Allergy Center, P.C. — Papillion, Nebraska, United States
Allergy & Asthma Associates — Las Vegas, Nevada, United States
Alabama Clinical Research Associates — Pell City, Alabama, United States

Full record on ClinicalTrials.gov

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