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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01545440




Registration number
NCT01545440
Ethics application status
Date submitted
1/03/2012
Date registered
6/03/2012
Date last updated
5/03/2015

Titles & IDs
Public title
A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)
Scientific 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
Secondary ID [1] 0 0
2011-004218-41
Secondary ID [2] 0 0
GB27862
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lebrikizumab
Treatment: Drugs - lebrikizumab
Treatment: Drugs - lebrikizumab
Treatment: Drugs - placebo

Experimental: lebrikizumab - highest dose -

Experimental: lebrikizumab - lowest dose -

Experimental: lebrikizumab - middle dose -

Placebo Comparator: placebo -


Treatment: Drugs: lebrikizumab
subcutaneous dose every 4 weeks

Treatment: Drugs: lebrikizumab
subcutaneous dose every 4 weeks

Treatment: Drugs: lebrikizumab
subcutaneous dose every 4 weeks

Treatment: Drugs: placebo
subcutaneous dose every 4 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of asthma exacerbations during the 52-week placebo-controlled period
Timepoint [1] 0 0
weeks 0-52
Secondary outcome [1] 0 0
Change in lung function: pre-bronchodilator FEV1
Timepoint [1] 0 0
from baseline to week 52
Secondary outcome [2] 0 0
Time to first asthma exacerbation
Timepoint [2] 0 0
from baseline to week 52
Secondary outcome [3] 0 0
Change in fractional exhaled nitric oxide (FeNO)
Timepoint [3] 0 0
from baseline to week 52
Secondary outcome [4] 0 0
Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S])
Timepoint [4] 0 0
from baseline to week 52
Secondary outcome [5] 0 0
Change in asthma rescue medication use
Timepoint [5] 0 0
from baseline to week 52
Secondary outcome [6] 0 0
Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period
Timepoint [6] 0 0
from baseline to week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Maine
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Missouri
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Nebraska
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Nevada
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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United States of America
State/province [28] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01545440
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications