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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01545453




Registration number
NCT01545453
Ethics application status
Date submitted
1/03/2012
Date registered
6/03/2012
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication
Secondary ID [1] 0 0
2011-004205-24
Secondary ID [2] 0 0
GB27864
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
Sex
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
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Brisbane
Recruitment postcode(s) [1] 0 0
4075 - Brisbane
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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California
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Colorado
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kansas
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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New Jersey
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Texas
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Utah
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Virginia
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Washington
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United States of America
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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/ct2/show/NCT01545453
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01545453