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

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ClinicalTrials.gov Identifier: NCT02104674
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: lebrikizumab Drug: montelukast [Singulair] Other: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN ADULT PATIENTS WITH MILD TO MODERATE ASTHMA
Study Start Date : June 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Placebo Other: placebo
SC injection given on Days 1, 29, and 57

Active Comparator: Singulair (montelukast) Drug: montelukast [Singulair]
10 mg given orally once daily for 12 weeks

Experimental: lebrikizumab Drug: lebrikizumab
Given SC on Days 1, 29, and 57




Primary Outcome Measures :
  1. Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: From Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Relative change in morning pre-bronchodilator peak expiratory flow (PEF) [ Time Frame: From Baseline to Week 12 ]
  2. Time to treatment failure [ Time Frame: From Baseline to Week 12 ]
  3. Change in asthma rescue medication use [ Time Frame: From Baseline to Week 12 ]
  4. Incidence of adverse events [ Time Frame: Approximately 20 weeks ]
  5. Pharmacodynamics: Relative change in fractional exhaled nitric oxide (FeNO) [ Time Frame: From Baseline to Week 12 ]
  6. Pharmacodynamics: Change in blood eosinophil count [ Time Frame: From Baseline to Week 12 ]
  7. Pharmacokinetics: Maximum serum lebrikizumab concentration after the first dose (Cmax) [ Time Frame: Week 1 ]
  8. Change in patient-reported outcome, as measured by the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)) [ Time Frame: From Baseline to Week 12 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104674


  Show 113 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02104674     History of Changes
Other Study ID Numbers: WA29249
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Antibodies, Monoclonal
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Immunologic Factors