A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma

September 4, 2017 updated by: Hoffmann-La Roche

A Phase II, Randomized, Double-Blind, Placebo-Controlled Bronchoscopy Study to Evaluate the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2S2
        • University of Alberta Hospital-SCC/WCM
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
        • VGH Research Pavilion
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Health Sciences Center
  • France
      • Montpellier, France, 34295
        • Hopital Arnaud de Villeneuve
      • Pessac, France, 33600
        • Groupe Hospitalier Sud - Hôpital Haut Lévêque
  • Ireland
      • Dublin, Ireland, 15
        • Connolly Hospital
  • Sweden
      • Lund, Sweden, 221 85
        • Skånes universitetssjukhus, Lund
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Queen's University Belfast; NICRN Respiratory Research Office
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital
      • London, United Kingdom, W2 1NY
        • St Mary's Hospital
      • Manchester, United Kingdom, M23 9QZ
        • The Medicines Evaluation Unit
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724-5030
        • University of Arizona
    • California
      • Los Angeles, California, United States, 90033
        • LAC-USC Medical Center
      • Sacramento, California, United States, 95817
        • University of California Davis Health System; Division of Pulmonary and Critical Care Medicine
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
    • Florida
      • Deerfield Beach, Florida, United States, Suite 200
        • University of Miami School of Medicine - Sylvester at Deerfield
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics; Internal Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital; Pulmonary Division
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University; Pediatrics
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157-1045
        • Wake Forest University Baptist Medical Center; Gastroenterology & Digestive Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital ; Lung Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Pen Memory Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Health System
    • Texas
      • Galveston, Texas, United States, 77555-0743
        • UTMB Pathology Clinical Services
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asthma diagnosis for greater than or equal to (>/=) 12 months prior to Visit 1
  • Bronchodilator response demonstrated within the 12 months before Visit 1 or at Visit 1, 2, or 3 of screening
  • 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 mcg of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study
  • On an eligible second controller medication (long-acting Beta-agonist [LABA), leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonists [LAMAs] or theophylline) for 6 months prior to Visit 1, with no changes within 4 weeks prior to Visit 1, and no anticipated changes throughout the study
  • Uncontrolled asthma at Visit 1 and/or 2 and at Visit 3
  • Chest X-ray or computed tomography (CT) scan within 12 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) that confirms the absence of other clinically significant lung disease
  • Demonstrated adherence with controller medication during the screening period

Exclusion Criteria:

  • Maintenance oral corticosteroid therapy, defined as daily alternate-day oral corticosteroid maintenance therapy within 3 months prior to Visit 1
  • Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the screening period for any reason, including an acute exacerbation event
  • Any infection requiring hospital, intravenous (IV) or intramuscular (IM) antibiotic treatment or any respiratory infection within 4 weeks prior to Visit 1 or during screening. Any infection requiring oral antibiotic treatment with 2 weeks prior to Visit 1 or during screening, or any parasitic 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
  • 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 a potential malignancy
  • Unable to safely undergo elective flexible fiberoptic bronchoscopy
  • Clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigator, to impact the participant's ability to participate in the study, or to impact the study assessments
  • History of alcohol or drug abuse that would impair or risk the participant's full participation in the study, in the opinion of the investigator
  • Current smoker or history of smoking (greater than [>] 10 pack-years), or unwillingness to abstain from smoking for the duration of the study
  • Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/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 Visit 1 (whichever is longer) or during screening
  • Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
  • Initiation of or increase in allergen immunotherapy within 3 months prior to Visit 1 or during screening
  • Body mass index >38 kilograms per square meter (kg/m^2)
  • Body weight <40 kilograms (kg)
  • History of bronchial thermoplasty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lebrikizumab
Participants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab on Days 1 and 8, and on Weeks 4 and 8.
Drug: Lebrikizumab
Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Other Names:
  • RO5490255
Drug: Inhaled corticposteroids (ICS)
Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
Drug: Second Asthma Controller Medication
Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
Placebo Comparator: Placebo
Participants with uncontrolled asthma on ICS therapy (not specified in the protocol) and a second controller medication, will receive SC injection of lebrikizumab matching placebo on Days 1 and 8, and on Weeks 4 and 8.
Drug: Inhaled corticposteroids (ICS)
Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
Drug: Second Asthma Controller Medication
Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
Drug: Placebo
Lebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Relative Change From Baseline in the Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells per Square Millimeter [Cells/mm^2])
Time Frame: From Baseline to Week 12
From Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Relative Change From Baseline in the Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Epithelial Eosinophils per Surface Area of Basal Lamina (Cells/mm^2)
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Relative Change From Baseline in Number of Airway Submucosal Eosinophils per Volume of Submucosa (Cells per Cubic Millimeter [Cells/mm^3])
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Submucosal Eosinophils per Volume of Submucosa (Cells/mm^3)
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Relative Change From Baseline in Number of Airway Epithelial Eosinophils per Volume of Epithelium (Cells/mm^3)
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Absolute Change From Baseline in Number of Airway Epithelial Eosinophils per Volume of Epithelium (Cells/mm^3)
Time Frame: Form Baseline to Week 12
Form Baseline to Week 12
Change From Baseline in Blood Eosinophil Count
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Change From Baseline in Immunoglobulin E (IgE) Levels
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Change From Baseline in Serum Periostin Levels
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Change From Baseline in Chemokine Ligand (CCL)-13 Levels
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Change From Baseline in CCL-17 Levels
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Chloride Channel Accessory 1 (CLCA1) Gene Expression
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell SerpinB2 Gene Expression at Week 12
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell CCL-26 Gene Expression
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Nitric Oxide Synthase 2 (NOS2) Gene Expression
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Change From Baseline in Lung Epithelial Cell Periostin (POSTN) Gene Expression
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Relative Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: From Baseline to Week 12
From Baseline to Week 12
Percentage of Participants With Treatment-Emergent Adverse Events
Time Frame: From Baseline to Week 20
From Baseline to Week 20
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Lebrikizumab
Time Frame: Baseline up to Week 20 (assessed at Baseline, Weeks 8 and 20/dosing termination or early termination)
Baseline up to Week 20 (assessed at Baseline, Weeks 8 and 20/dosing termination or early termination)
Serum Lebrikizumab Concentration at Week 12
Time Frame: Predose (Hour 0) at Week 12
Predose (Hour 0) at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GB29260
  • 2014-000275-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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