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

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ClinicalTrials.gov Identifier: NCT01875003
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.

Condition or disease Intervention/treatment Phase
Asthma Drug: Lebrikizumab Drug: Placebo Drug: Standard of Care Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : August 31, 2013
Actual Primary Completion Date : December 28, 2016
Actual Study Completion Date : December 28, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Lebrikizumab High
Participants with uncontrolled asthma on ICS therapy (total daily dose of 500−2000 micrograms [mcg] of fluticasone propionate dry powder inhaler [DPI] or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (high dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period.
Drug: Lebrikizumab
Lebrikizumab will be administered as SC injection at high or low dose Q4W.

Drug: Standard of Care
Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists [LABAs], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.

Experimental: Lebrikizumab Low
Participants with uncontrolled asthma on ICS therapy (total daily dose of 500−2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (low dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period.
Drug: Lebrikizumab
Lebrikizumab will be administered as SC injection at high or low dose Q4W.

Drug: Standard of Care
Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists [LABAs], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.

Placebo Comparator: Placebo
Participants with uncontrolled asthma on ICS therapy (total daily dose of 500−2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab matching placebo Q4W for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at high or low dose will be administered from Weeks 52 to 76 or 104 to participants who are willing to take part in optional active-treatment extension period.
Drug: Lebrikizumab
Lebrikizumab will be administered as SC injection at high or low dose Q4W.

Drug: Placebo
Lebrikizumab matching placebo will be administered as SC injection Q4W.

Drug: Standard of Care
Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists [LABAs], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.




Primary Outcome Measures :
  1. Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period [ Time Frame: Baseline up to Week 52 ]
  2. Percentage of Participants With Adverse Events (AEs) or Serious AEs [ Time Frame: Baseline up to Week 124 ]
  3. Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab [ Time Frame: Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 76, 104, 112, and 124 or at early termination [up to 108 weeks]) ]

Secondary Outcome Measures :
  1. Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at Week 52 [ Time Frame: Baseline , Week 52 ]
  2. Time to First Asthma Exacerbation [ Time Frame: Baseline up to 52 weeks ]
  3. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 52 [ Time Frame: Baseline , Week 52 ]
  4. Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and Older (AQLQ + 12) at Week 52 [ Time Frame: Baseline, Week 52 ]
  5. Change From Baseline in Asthma Rescue Medication Use at Week 52 [ Time Frame: Baseline, Week 52 ]
  6. Rate of Urgent Asthma-Related Health Care Utilization [ Time Frame: Baseline up to 52 weeks ]
  7. Injection Acceptability Questionnaire (IAQ) Score [ Time Frame: Baseline up to Week 104 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1
  • Bronchodilator response during screening
  • Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3
  • On high dose 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 prior to 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 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, human immunodeficiency virus (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 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 (whichever is longer) prior to Visit 1
  • Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
  • 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): NCT01875003


  Show 165 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01875003     History of Changes
Other Study ID Numbers: WB28183
2012-000180-25 ( EudraCT Number )
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Antibodies, Monoclonal
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Immunologic Factors