The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02104674




Registration number
NCT02104674
Ethics application status
Date submitted
26/03/2014
Date registered
4/04/2014
Date last updated
2/11/2016

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
Scientific 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
Secondary ID [1] 0 0
WA29249
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lebrikizumab
Treatment: Drugs - montelukast [Singulair]
Other interventions - placebo

Placebo Comparator: Placebo -

Active Comparator: Singulair (montelukast) -

Experimental: lebrikizumab -


Treatment: Drugs: lebrikizumab
Given SC on Days 1, 29, and 57

Treatment: Drugs: montelukast [Singulair]
10 mg given orally once daily for 12 weeks

Other interventions: placebo
SC injection given on Days 1, 29, and 57

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Timepoint [1] 0 0
From Baseline to Week 12
Secondary outcome [1] 0 0
Relative change in morning pre-bronchodilator peak expiratory flow (PEF)
Timepoint [1] 0 0
From Baseline to Week 12
Secondary outcome [2] 0 0
Time to treatment failure
Timepoint [2] 0 0
From Baseline to Week 12
Secondary outcome [3] 0 0
Change in asthma rescue medication use
Timepoint [3] 0 0
From Baseline to Week 12
Secondary outcome [4] 0 0
Incidence of adverse events
Timepoint [4] 0 0
Approximately 20 weeks
Secondary outcome [5] 0 0
Pharmacodynamics: Relative change in fractional exhaled nitric oxide (FeNO)
Timepoint [5] 0 0
From Baseline to Week 12
Secondary outcome [6] 0 0
Pharmacodynamics: Change in blood eosinophil count
Timepoint [6] 0 0
From Baseline to Week 12
Secondary outcome [7] 0 0
Pharmacokinetics: Maximum serum lebrikizumab concentration after the first dose (Cmax)
Timepoint [7] 0 0
Week 1
Secondary outcome [8] 0 0
Change in patient-reported outcome, as measured by the Standardized Asthma Quality of Life Questionnaire (AQLQ(S))
Timepoint [8] 0 0
From Baseline to Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Brazil
State/province [23] 0 0
RJ
Country [24] 0 0
Brazil
State/province [24] 0 0
RS
Country [25] 0 0
Brazil
State/province [25] 0 0
SC
Country [26] 0 0
Brazil
State/province [26] 0 0
SP
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Gabrovo
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Razgrad
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Ruse
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Varna
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Veliko Tarnovo
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Jablonec nad Nisou
Country [35] 0 0
Czech Republic
State/province [35] 0 0
Jindrichuv Hradec
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Karlovy Vary - Stará Role
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Strakonice
Country [38] 0 0
Georgia
State/province [38] 0 0
Tbilisi
Country [39] 0 0
New Zealand
State/province [39] 0 0
Auckland City
Country [40] 0 0
New Zealand
State/province [40] 0 0
Auckland
Country [41] 0 0
New Zealand
State/province [41] 0 0
Beckenham
Country [42] 0 0
Poland
State/province [42] 0 0
Bialystok
Country [43] 0 0
Poland
State/province [43] 0 0
Krakow
Country [44] 0 0
Poland
State/province [44] 0 0
Lodz
Country [45] 0 0
Poland
State/province [45] 0 0
Lublin
Country [46] 0 0
Poland
State/province [46] 0 0
Poznan
Country [47] 0 0
Poland
State/province [47] 0 0
Tarnow
Country [48] 0 0
Poland
State/province [48] 0 0
Wroclaw
Country [49] 0 0
Puerto Rico
State/province [49] 0 0
Caguas
Country [50] 0 0
Puerto Rico
State/province [50] 0 0
San Juan
Country [51] 0 0
Romania
State/province [51] 0 0
Bucuresti
Country [52] 0 0
Romania
State/province [52] 0 0
Cluj-Napoca
Country [53] 0 0
Romania
State/province [53] 0 0
Iasi
Country [54] 0 0
Romania
State/province [54] 0 0
Oradea
Country [55] 0 0
Romania
State/province [55] 0 0
Timisoara
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Ekaterinburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Moscow
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Ryazan
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Saint Petersburg
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Saratov
Country [61] 0 0
Russian Federation
State/province [61] 0 0
St Petersburg
Country [62] 0 0
Russian Federation
State/province [62] 0 0
St. Petersburg
Country [63] 0 0
Slovakia
State/province [63] 0 0
Spisska Nova Ves
Country [64] 0 0
South Africa
State/province [64] 0 0
Cape Town
Country [65] 0 0
South Africa
State/province [65] 0 0
Johannesburg
Country [66] 0 0
South Africa
State/province [66] 0 0
Lyttleton
Country [67] 0 0
South Africa
State/province [67] 0 0
Parow
Country [68] 0 0
South Africa
State/province [68] 0 0
Pretoria Gauteng Province
Country [69] 0 0
South Africa
State/province [69] 0 0
Soweto
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02104674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications