A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: lebrikizumab Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Steroids

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Rate of asthma exacerbations during the 52-week placebo-controlled period [ Time Frame: weeks 0-52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in lung function: pre-bronchodilator FEV1 [ Time Frame: from baseline to week 52 ] [ Designated as safety issue: No ]
Time to first asthma exacerbation [ Time Frame: from baseline to week 52 ] [ Designated as safety issue: No ]
Change in fractional exhaled nitric oxide (FeNO) [ Time Frame: from baseline to week 52 ] [ Designated as safety issue: No ]
Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) [ Time Frame: from baseline to week 52 ] [ Designated as safety issue: No ]
Change in asthma rescue medication use [ Time Frame: from baseline to week 52 ] [ Designated as safety issue: No ]
Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period [ Time Frame: from baseline to week 52 ] [ Designated as safety issue: No ]

Enrollment:	204
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: lebrikizumab - highest dose	Drug: lebrikizumab subcutaneous dose every 4 weeks
Experimental: lebrikizumab - middle dose	Drug: lebrikizumab subcutaneous dose every 4 weeks
Experimental: lebrikizumab - lowest dose	Drug: lebrikizumab subcutaneous dose every 4 weeks
Placebo Comparator: placebo	Drug: placebo subcutaneous dose every 4 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 screeing period

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 druing 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545453

Show 66 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Clinical Trials

Genentech

More Information

Additional Information:

study website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01545453 History of Changes
Other Study ID Numbers:	GB27864, 2011-004205-24
Study First Received:	March 1, 2012
Last Updated:	March 8, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013