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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01545453
First received: March 1, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This randomized, multicenter, double-blind, placebo-controlled, parallel-group s tudy will assess the efficacy and safety of lebrikizumab in patients with asthm a whose disease remains uncontrolled despite daily therapy with an inhaled cort icosteroid 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 a ddition to their standard-of-care therapy. This will be followed by a 52-week do uble-blind active treatment extension. The anticipated time on study treatment i s up to 104 weeks. There will be a safety follow-up of 24 weeks after the last d ose 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:


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: 205
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: January 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 63 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

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: September 2, 2014
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 September 18, 2014