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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01545453
Collaborator
(none)
205
Enrollment
64
Locations
4
Arms
16
Duration (Months)
3.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
205 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: lebrikizumab - highest dose

Drug: lebrikizumab
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - lowest dose

Drug: lebrikizumab
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - middle dose

Drug: lebrikizumab
subcutaneous dose every 4 weeks
Placebo Comparator: placebo

Drug: placebo
subcutaneous dose every 4 weeks

Outcome Measures

Primary Outcome Measures

  1. Rate of asthma exacerbations during the 52-week placebo-controlled period [weeks 0-52]

Secondary Outcome Measures

  1. Change in lung function: pre-bronchodilator FEV1 [from baseline to week 52]

  2. Time to first asthma exacerbation [from baseline to week 52]

  3. Change in fractional exhaled nitric oxide (FeNO) [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]) [from baseline to week 52]

  5. Change in asthma rescue medication use [from baseline to week 52]

  6. Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period [from baseline to week 52]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Oxford Alabama United States 36203-7190
2 Long Beach California United States 90808
3 Los Angeles California United States 90025
4 Orange California United States 92868
5 Redwood City California United States 94063
6 San Mateo California United States 94401
7 Stockton California United States 95207
8 Centennial Colorado United States 80112
9 Colorado Springs Colorado United States 80907
10 Kissimmee Florida United States 34741
11 Miami Florida United States 33173
12 Panama City Florida United States 32405
13 Columbus Georgia United States 31904
14 Decatur Georgia United States 30033
15 Woodstock Georgia United States 30188
16 Twin Falls Idaho United States 83301
17 Normal Illinois United States 61761
18 Indianapolis Indiana United States 46208
19 Lafayette Indiana United States 47904
20 Overland Park Kansas United States 66210
21 Baltimore Maryland United States 21236
22 Brockton Massachusetts United States 02301
23 Bay City Michigan United States 48706
24 Novi Michigan United States 48375
25 Ypsilanti Michigan United States 48197
26 Minneapolis Minnesota United States 55402
27 Plymouth Minnesota United States 55441
28 Chesterfield Missouri United States 63017
29 Saint Louis Missouri United States 63141
30 St Louis Missouri United States 63141
31 Missoula Montana United States 59808
32 Omaha Nebraska United States 68130
33 Brick New Jersey United States 08724
34 Edison New Jersey United States 08820
35 Ocean New Jersey United States 07712
36 Teaneck New Jersey United States 07666
37 Verona New Jersey United States 07044
38 North Syracuse New York United States 13212
39 Canton Ohio United States 44718
40 Centerville Ohio United States 45458
41 Cincinnati Ohio United States 45242
42 Toledo Ohio United States 43617
43 Oklahoma City Oklahoma United States 73120
44 Tulsa Oklahoma United States 74136
45 Medford Oregon United States 97504
46 Altoona Pennsylvania United States 16601
47 Hershey Pennsylvania United States 17033
48 Philadelphia Pennsylvania United States 19107
49 Pittsburgh Pennsylvania United States 15241
50 Pittsburg Pennsylvania United States PA
51 Sellersville Pennsylvania United States 18960
52 Columbia South Carolina United States 29201
53 Greenville South Carolina United States 29615
54 Austin Texas United States 78750
55 Austin Texas United States 78759
56 Boerne Texas United States 78006
57 El Paso Texas United States 79903
58 Houston Texas United States 77030
59 Sugar Land Texas United States 77479
60 Murray Utah United States 84107
61 Fairfax Virginia United States 22030
62 Spokane Washington United States 99204
63 Madison Wisconsin United States 53715
64 Brisbane Queensland Australia 4075

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01545453
Other Study ID Numbers:
  • GB27864
  • 2011-004205-24
First Posted:
Mar 6, 2012
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Asthma
Antibodies, Monoclonal

Study Results

No Results Posted as of Nov 2, 2016