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A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02104674
Collaborator
(none)
313
Enrollment
113
Locations
3
Arms
23
Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
313 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 EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN ADULT PATIENTS WITH MILD TO MODERATE ASTHMA
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Other: placebo
SC injection given on Days 1, 29, and 57
Active Comparator: Singulair (montelukast)

Drug: montelukast [Singulair]
10 mg given orally once daily for 12 weeks
Experimental: lebrikizumab

Drug: lebrikizumab
Given SC on Days 1, 29, and 57

Outcome Measures

Primary Outcome Measures

  1. Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) [From Baseline to Week 12]

Secondary Outcome Measures

  1. Relative change in morning pre-bronchodilator peak expiratory flow (PEF) [From Baseline to Week 12]

  2. Time to treatment failure [From Baseline to Week 12]

  3. Change in asthma rescue medication use [From Baseline to Week 12]

  4. Incidence of adverse events [Approximately 20 weeks]

  5. Pharmacodynamics: Relative change in fractional exhaled nitric oxide (FeNO) [From Baseline to Week 12]

  6. Pharmacodynamics: Change in blood eosinophil count [From Baseline to Week 12]

  7. Pharmacokinetics: Maximum serum lebrikizumab concentration after the first dose (Cmax) [Week 1]

  8. Change in patient-reported outcome, as measured by the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)) [From Baseline to Week 12]

Eligibility Criteria

Criteria

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

  • Age 18-75 years old at study start

  • Asthma diagnosis for >/= 12 months prior to study start

  • Bronchodilator response at screening

  • Pre-bronchodilator FEV1 of 60% - 85% predicted at both screening visits 2 and 3

  • No other clinically significant lung disease as confirmed by chest X-ray or computed tomography (CT) scan

  • Stable and symptomatic asthma during the screening period

  • Use of effective contraception, as defined by the protocol, until 24 weeks after the last dose

Exclusion Criteria:

  • Maintenance of corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy within 3 months prior to study start

  • Treatment with systemic or inhaled corticosteroids within 4 weeks prior to study start or during the screening period for any reason, including an acute exacerbation event

  • Treatment with a leukotriene receptor antagonist (LTRA), long-acting beta-agonist (LABA) long-acting muscarinic antagonist (LAMA), zileuton, roflumilast, or theophylline within 2 weeks prior to study start

  • Documented prior treatment failure with Montelukast

  • Treatment with intra-articular corticosteroids within 4 weeks prior to study start or during the screening period or anticipated need for intra articular corticosteroids during the course of the study

  • Any infection requiring hospital, IV or IM antibiotic treatment or any respiratory infection within 4 weeks of study start. Any infection requiring oral antibiotic treatment within 2 weeks of study start, or any parasitic infection within 6 months of study start

  • Clinically significant abnormality found during screening or clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study, or impact the study assessments

  • History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma

  • History of alcohol or drug abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator

  • Current or history of smoking (> 10 pack-years), or unwillingness to abstain from smoking for the duration of the study

  • Past and/or current use of any anti-IL-13 or anti- IL4/IL-13 therapy, including lebrikizumab

  • Use of a licensed or investigational monoclonal antibody other than anti IL-13 or anti-IL-4/IL-13, including, but not limited to, omalizumab, anti-IL-5, or anti IL-17, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening

  • Use of a systemic immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to study start or during screening

  • Use of other investigational therapy within 4 weeks or 5 drug half-lives prior to study start (whichever is longer) or during screening

  • Initiation of or change in allergen immunotherapy within 3 months prior to study start or during screening

  • Receipt of a live attenuated vaccine within 4 weeks prior to study start of during screening

  • Pregnancy or breast feeding

  • Body mass index > 38 kg/m2

  • Body weight < 40 kg

  • History of bronchial thermoplasty

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birmingham Alabama United States 35209
2 Flagstaff Arizona United States 86001
3 Scottsdale Arizona United States 85251
4 Alhambra California United States 91801
5 Anaheim California United States 92801
6 Los Angeles California United States 90025
7 Los Angeles California United States 90048
8 Napa California United States 94558
9 Rancho Mirage California United States 92270
10 Redwood City California United States 94063
11 Stockton California United States 95207
12 Upland California United States 91786
13 Colorado Springs Colorado United States 80907
14 Denver Colorado United States 80206
15 Waterbury Connecticut United States 06708
16 Cooper City Florida United States 33024
17 Kissimmee Florida United States 34741
18 New Port Richey Florida United States 34653
19 Winter Park Florida United States 32789
20 Columbus Georgia United States 31904
21 Duluth Georgia United States 30096
22 Normal Illinois United States 61761
23 Oak Lawn Illinois United States 60453
24 River Forest Illinois United States 60305
25 Avon Indiana United States 46123
26 Louisville Kentucky United States 40223
27 Minneapolis Minnesota United States 55402
28 Plymouth Minnesota United States 55441
29 Saint Louis Missouri United States 63141
30 Papillion Nebraska United States 68046
31 Ocean New Jersey United States 07712
32 Bronx New York United States 10459
33 Rochester New York United States 14618
34 Hendersonville North Carolina United States 28739
35 High Point North Carolina United States 27262
36 Oklahoma City Oklahoma United States 73120
37 Medford Oregon United States 97504
38 Portland Oregon United States 97202
39 Greer South Carolina United States 29651
40 Boerne Texas United States 78006
41 Dallas Texas United States 75231
42 Houston Texas United States 77034
43 Humble Texas United States 77338
44 McKinney Texas United States 75069
45 San Antonio Texas United States 78207
46 San Antonio Texas United States 78249
47 San Antonio Texas United States 78251
48 Tomball Texas United States 77375
49 Waco Texas United States 76712
50 Fairfax Virginia United States 22030
51 Henrico Virginia United States 23233
52 Greenfield Wisconsin United States 53228
53 Rio de Janeiro RJ Brazil 22271-100
54 Porto Alegre RS Brazil 90020-090
55 Florianopolis SC Brazil 88040-970
56 Santo Andre SP Brazil 09060-650
57 Santo Andre SP Brazil 09080-000
58 Gabrovo Bulgaria 5300
59 Razgrad Bulgaria 7200
60 Ruse Bulgaria 7002
61 Sofia Bulgaria 1000
62 Sofia Bulgaria 1431
63 Varna Bulgaria 9019
64 Veliko Tarnovo Bulgaria 5000
65 Brampton Ontario Canada L6T 0G1
66 Toronto Ontario Canada M9V 4B4
67 Jablonec nad Nisou Czech Republic 46601
68 Jindrichuv Hradec Czech Republic 37701
69 Karlovy Vary - Stará Role Czech Republic 360 17
70 Strakonice Czech Republic 38601
71 Tbilisi Georgia 0119
72 Auckland City New Zealand 0626
73 Auckland New Zealand 1010
74 Beckenham New Zealand 8024
75 Bialystok Poland 15-276
76 Krakow Poland 31-023
77 Krakow Poland 31-159
78 Lodz Poland 90-153
79 Lublin Poland 20-089
80 Poznan Poland 60-693
81 Poznan Poland 60-823
82 Tarnow Poland 33-100
83 Wroclaw Poland 53-201
84 Wroclaw Poland 54-239
85 Caguas Puerto Rico 00725
86 San Juan Puerto Rico 00909-1711
87 San Juan Puerto Rico 00918
88 Bucuresti Romania 030303
89 Cluj-Napoca Romania 400371
90 Iasi Romania 700115
91 Oradea Romania 410176
92 Timisoara Romania 300310
93 Ekaterinburg Russian Federation 620109
94 Moscow Russian Federation 119991
95 Ryazan Russian Federation 390011
96 Saint Petersburg Russian Federation 190068
97 Saint Petersburg Russian Federation 194295
98 Saratov Russian Federation 410053
99 St Petersburg Russian Federation 193231
100 St Petersburg Russian Federation 197089
101 St. Petersburg Russian Federation 194354
102 St. Petersburg Russian Federation 197089
103 St. Petersburg Russian Federation 197706
104 Spisska Nova Ves Slovakia 052 01
105 Cape Town South Africa 7130
106 Cape Town South Africa 7530
107 Cape Town South Africa 7700
108 Johannesburg South Africa 2113
109 Lyttleton South Africa 0157
110 Parow South Africa 7505
111 Pretoria Gauteng Province South Africa 0087
112 Soweto South Africa 1818
113 Manchester United Kingdom M23 9QZ

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02104674
Other Study ID Numbers:
  • WA29249
First Posted:
Apr 4, 2014
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Asthma
Montelukast

Study Results

No Results Posted as of Nov 2, 2016