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

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01545440
• Collaborator: (none)
• Enrollment: 258
• Locations: 71
• Arms: 4
• Duration (Months): 16
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.2

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
Asthma	Drug: lebrikizumab; Drug: lebrikizumab; Drug: lebrikizumab; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 258 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 Safety and Efficacy 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: Mar 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		Pell City	Alabama	United States	35128
2		Scottsdale	Arizona	United States	85251
3		Scottsdale	Arizona	United States	85266
4		Tucson	Arizona	United States	85712
5		Bakersfield	California	United States	93301
6		Fountain Valley	California	United States	92708
7		Fullerton	California	United States	92835
8		Los Angeles	California	United States	90025
9		Los Angeles	California	United States	90048
10		Mission Viejo	California	United States	92691
11		Napa	California	United States	94558
12		Orange	California	United States	92868
13		Rancho Mirage	California	United States	92270
14		Sacramento	California	United States	95819
15		San Diego	California	United States	92108
16		Studio City	California	United States	91607
17		Upland	California	United States	91786
18		Walnut Creek	California	United States	94598
19		Centennial	Colorado	United States	80112
20		Colorado Springs	Colorado	United States	80907
21		Denver	Colorado	United States	80206
22		Wheat Ridge	Colorado	United States	80033
23		Waterbury	Connecticut	United States	06708
24		Gainesville	Florida	United States	32605
25		North Palm Beach	Florida	United States	33408
26		Ocala	Florida	United States	34471
27		Tallahassee	Florida	United States	32308
28		Tampa	Florida	United States	33613
29		Winter Park	Florida	United States	32789
30		Albany	Georgia	United States	31707
31		Savannah	Georgia	United States	31406
32		Honolulu	Hawaii	United States	96814
33		River Forest	Illinois	United States	60305
34		Topeka	Kansas	United States	66606
35		Metairie	Louisiana	United States	70006
36		Bangor	Maine	United States	04401
37		Kansas City	Missouri	United States	64114
38		Bellevue	Nebraska	United States	68123
39		Las Vegas	Nevada	United States	89106
40		Las Vegas	Nevada	United States	89119
41		Albuquerque	New Mexico	United States	87131
42		Bronx	New York	United States	10461
43		Great Neck	New York	United States	11021
44		New York	New York	United States	10016
45		Rockville Centre	New York	United States	11570
46		High Point	North Carolina	United States	27262
47		Wilmington	North Carolina	United States	28401
48		Cincinnati	Ohio	United States	45231
49		Eugene	Oregon	United States	97401-7721
50		Lake Oswego	Oregon	United States	97035
51		Portland	Oregon	United States	97202
52		Blue Bell	Pennsylvania	United States	19422
53		Easton	Pennsylvania	United States	18045
54		Harrisburg	Pennsylvania	United States	17110
55		Philadelphia	Pennsylvania	United States	19115
56		Upland	Pennsylvania	United States	19013
57		Warwick	Rhode Island	United States	02865
58		Greenville	South Carolina	United States	29607
59		Spartanburg	South Carolina	United States	29303
60		Knoxville	Tennessee	United States	37909
61		Arlington	Texas	United States	76018
62		Dallas	Texas	United States	75230
63		El Paso	Texas	United States	79925
64		Fort worth	Texas	United States	76109
65		McKinney	Texas	United States	75069
66		San Antonio	Texas	United States	78224
67		San Antonio	Texas	United States	78251
68		Henrico	Virginia	United States	23233
69		Seattle	Washington	United States	98105
70		Madison	Wisconsin	United States	53792
71		Nedlands	Western Australia	Australia	6009

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• study website

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01545440
• Other Study ID Numbers: GB27862; 2011-004218-41
• First Posted: Mar 6, 2012
• Last Update Posted: Mar 5, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Asthma; Antibodies, Monoclonal

Study Results

No Results Posted as of Mar 5, 2015