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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545453
• Other study ID #: GB27864
• Secondary ID: 2011-004205-24
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2012
• Last updated: November 1, 2016
• Start date: March 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• lebrikizumab
subcutaneous dose every 4 weeks
• lebrikizumab
subcutaneous dose every 4 weeks
• lebrikizumab
subcutaneous dose every 4 weeks
• placebo
subcutaneous dose every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of asthma exacerbations during the 52-week placebo-controlled period		weeks 0-52	No
Secondary	Change in lung function: pre-bronchodilator FEV1		from baseline to week 52	No
Secondary	Time to first asthma exacerbation		from baseline to week 52	No
Secondary	Change in fractional exhaled nitric oxide (FeNO)		from baseline to week 52	No
Secondary	Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S])		from baseline to week 52	No
Secondary	Change in asthma rescue medication use		from baseline to week 52	No
Secondary	Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period		from baseline to week 52	No