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A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: March 1, 2012
Last updated: March 3, 2015
Last verified: March 2015
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo 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 is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.

Condition Intervention Phase
Drug: lebrikizumab
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Rate of asthma exacerbations during the 52-week placebo-controlled period [ Time Frame: weeks 0-52 ]

Secondary Outcome Measures:
  • Change in lung function: pre-bronchodilator FEV1 [ Time Frame: from baseline to week 52 ]
  • Time to first asthma exacerbation [ Time Frame: from baseline to week 52 ]
  • Change in fractional exhaled nitric oxide (FeNO) [ Time Frame: from baseline to week 52 ]
  • Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) [ Time Frame: from baseline to week 52 ]
  • Change in asthma rescue medication use [ Time Frame: from baseline to week 52 ]
  • Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period [ Time Frame: from baseline to week 52 ]

Enrollment: 258
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lebrikizumab - highest dose Drug: lebrikizumab
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - lowest dose Drug: lebrikizumab
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - middle dose Drug: lebrikizumab
subcutaneous dose every 4 weeks
Placebo Comparator: placebo Drug: placebo
subcutaneous dose every 4 weeks


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, 18 to 75 years of age at Visit 1
  • Asthma diagnosis for >/= 12 months prior to the start of screening (Visit 1)
  • Bronchodilator response during screening
  • Pre-bronchodilator FEV1 40%-80% of predicted during screening
  • On ICS (inhaled corticosteroids) 500-2000 mcg/day of fluticasone propionate DPI or equivalent for >/= 6 months prior to the start of screening (Visit 1) with no anticipated changes throughout the study
  • On an eligible second controller medication (LABA, LAMA, LTRA or theophylline within the prescribed dosing range)
  • Uncontrolled asthma as defined by protocol both during screening period and at time of randomization
  • Chest X-ray or computed tomography (CT) scan obtained within 12 months prior to screening or chest X-ray during screening period confirming the absence of other lung disease
  • Demonstrated adherence with controller medication during the screening period

Exclusion Criteria:

  • History of severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
  • Use of zileuton or roflumilast within 6 months prior to screening
  • Maintenance oral corticosteroid therapy, defined as daily or alternate day oral corticosteroid maintenance therapy within the 3 months prior to Visit 1
  • Treatment with systemic (oral, intravenous or intramuscular) corticosteroids within the 4 weeks prior to Visit 1
  • Major episode of infection within 4 weeks prior to Visit 1 or treatment with oral antibiotics within 2 weeks prior to Visit 1
  • Active parasitic infection within the 6 months prior to Visit 1
  • Active tuberculosis requiring treatment within the 12 months prior to Visit 1
  • Known immunodeficiency, including, but not limited to, HIV infection
  • Evidence of acute or chronic hepatitis or known liver cirrhosis
  • History of cystic fibrosis, chronic obstructive pulmonary disease, and/or other clinically significant lung disease other than asthma
  • Known malignancy or current evaluation for a potential malignancy
  • Current smoker or former smoker with a history >10 pack years
  • History of alcohol, drug or chemical abuse
  • Initiation or change in allergen immunotherapy within 3 months prior to Visit 1
  • Use of biologic therapy including omalizumab during 6 months prior to Visit 1
  • Receipt of live/attenuated vaccine within 4 weeks prior to Visit 1
  • Pregnant or lactating women
  • Body mass index (BMI) > 38 kg/m2
  • Body weight < 40 kg
  Contacts and Locations
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Please refer to this study by its identifier: NCT01545440

  Show 71 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Genentech, Inc. Identifier: NCT01545440     History of Changes
Other Study ID Numbers: GB27862
2011-004218-41 ( EudraCT Number )
Study First Received: March 1, 2012
Last Updated: March 3, 2015

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on April 21, 2017