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AsthmaPhase 2NCT01545440

A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)

A Phase 2 study testing lebrikizumab in people with Asthma, run by Genentech, Inc. at 71 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
lebrikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
258 participants
Where
71 sitesin 2 countries
Study dates
Mar 2012to Jul 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

71 sites in 2 countries.

71 sites in 2 countries

United States70 sites

  • Study site

    Albany, Georgia, 31707

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Arlington, Texas, 76018

  • Study site

    Bakersfield, California, 93301

  • Study site

    Bangor, Maine, 04401

  • Study site

    Bellevue, Nebraska, 68123

  • Study site

    Blue Bell, Pennsylvania, 19422

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Cincinnati, Ohio, 45231

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Dallas, Texas, 75230

  • Study site

    Denver, Colorado, 80206

  • Study site

    Easton, Pennsylvania, 18045

  • Study site

    El Paso, Texas, 79925

  • Study site

    Eugene, Oregon, 97401-7721

  • Study site

    Fort Worth, Texas, 76109

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Fullerton, California, 92835

  • Study site

    Gainesville, Florida, 32605

  • Study site

    Great Neck, New York, 11021

  • Study site

    Greenville, South Carolina, 29607

  • Study site

    Harrisburg, Pennsylvania, 17110

  • Study site

    Henrico, Virginia, 23233

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Knoxville, Tennessee, 37909

  • Study site

    Lake Oswego, Oregon, 97035

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Las Vegas, Nevada, 89119

  • Study site

    Los Angeles, California, 90025

  • Study site

    Los Angeles, California, 90048

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    McKinney, Texas, 75069

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Mission Viejo, California, 92691

  • Study site

    Napa, California, 94558

  • Study site

    New York, New York, 10016

  • Study site

    North Palm Beach, Florida, 33408

  • Study site

    Ocala, Florida, 34471

  • Study site

    Orange, California, 92868

  • Study site

    Pell City, Alabama, 35128

  • Study site

    Philadelphia, Pennsylvania, 19115

  • Study site

    Portland, Oregon, 97202

  • Study site

    Rancho Mirage, California, 92270

  • Study site

    River Forest, Illinois, 60305

  • Study site

    Rockville Centre, New York, 11570

  • Study site

    Sacramento, California, 95819

  • Study site

    San Antonio, Texas, 78224

  • Study site

    San Antonio, Texas, 78251

  • Study site

    San Diego, California, 92108

  • Study site

    Savannah, Georgia, 31406

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    Scottsdale, Arizona, 85266

  • Study site

    Seattle, Washington, 98105

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Studio City, California, 91607

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    Tampa, Florida, 33613

  • Study site

    The Bronx, New York, 10461

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Upland, California, 91786

  • Study site

    Upland, Pennsylvania, 19013

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Warwick, Rhode Island, 02865

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    Wheat Ridge, Colorado, 80033

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winter Park, Florida, 32789

Other trials in United States

Australia1 site

  • Study site

    Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official 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

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.

Conditions
Asthma
Being tested
lebrikizumab, placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lebrikizumabDrug

    subcutaneous dose every 4 weeks

  • lebrikizumabDrug

    subcutaneous dose every 4 weeks

  • lebrikizumabDrug

    subcutaneous dose every 4 weeks

  • placeboDrug

    subcutaneous dose every 4 weeks

Study groups in NCT01545440
Study groupRoleWhat they receive
lebrikizumab - highest doseExperimentalNot described
Receives: Drug: lebrikizumab
lebrikizumab - lowest doseExperimentalNot described
Receives: Drug: lebrikizumab
lebrikizumab - middle doseExperimentalNot described
Receives: Drug: lebrikizumab
placeboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of asthma exacerbations during the 52-week placebo-controlled period

    Measured: weeks 0-52

Secondary outcomes (6)

  1. Change in lung function: pre-bronchodilator FEV1

    Measured: from baseline to week 52

  2. Time to first asthma exacerbation

    Measured: from baseline to week 52

  3. Change in fractional exhaled nitric oxide (FeNO)

    Measured: from baseline to week 52

  4. Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S])

    Measured: from baseline to week 52

  5. Change in asthma rescue medication use

    Measured: from baseline to week 52

  6. Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period

    Measured: from baseline to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMar 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01545440
Sponsor's protocol ID
GB27862
Other IDs
2011-004218-41
Status last verified
Mar 2015
First submitted
1 Mar 2012
Last updated
5 Mar 2015
Results posted
No

Publications

  • Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.

    PubMed 33217063

  • Hanania NA, Noonan M, Corren J, Korenblat P, Zheng Y, Fischer SK, Cheu M, Putnam WS, Murray E, Scheerens H, Holweg CT, Maciuca R, Gray S, Doyle R, McClintock D, Olsson J, Matthews JG, Yen K. Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies. Thorax. 2015 Aug;70(8):748-56. doi: 10.1136/thoraxjnl-2014-206719. Epub 2015 May 22.

    PubMed 26001563

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lebrikizumab in people with Asthma, run by Genentech, Inc. at 71 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of asthma exacerbations during the 52-week placebo-controlled period (time frame: weeks 0-52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01545440, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.

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