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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01868061




Registration number
NCT01868061
Ethics application status
Date submitted
30/05/2013
Date registered
4/06/2013
Date last updated
19/05/2017

Titles & IDs
Public title
A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication
Scientific 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
Secondary ID [1] 0 0
2013-000176-15
Secondary ID [2] 0 0
GB28689
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 - Placebo

Experimental: Lebrikizumab (125 mg) - Participants will receive SC injection of lebrikizumab (125 mg) every 4 weeks for 104 weeks.

Experimental: Lebrikizumab (37.5 mg) - Participants will receive SC injection of lebrikizumab (37.5 mg) every 4 weeks for 104 weeks.

Placebo comparator: Placebo - Participants will receive SC injection of lebrikizumab matching placebo every 4 weeks for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at 125 or 37.5 mg for 52 weeks during active treatment extension period.


Treatment: Drugs: Lebrikizumab
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.

Treatment: Drugs: Placebo
Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period
Timepoint [1] 0 0
Baseline up to Week 52
Secondary outcome [1] 0 0
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Time to First Asthma Exacerbation
Timepoint [2] 0 0
Baseline up to Week 52
Secondary outcome [3] 0 0
Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments)
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Rate of Urgent Asthma-Related Urgent Health Care Utilization
Timepoint [5] 0 0
Baseline up to Week 52
Secondary outcome [6] 0 0
Percentage of Participants With Adverse Events
Timepoint [6] 0 0
Baseline up to Week 124
Secondary outcome [7] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab
Timepoint [7] 0 0
Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124)
Secondary outcome [8] 0 0
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score
Timepoint [8] 0 0
Baseline, Week 52
Secondary outcome [9] 0 0
Minimum Serum Concentration (Cmin) of Lebrikizumab
Timepoint [9] 0 0
Predose (0 hour) on Weeks 4, 12, 24, 36, and 52

Eligibility
Key inclusion criteria
* Asthma diagnosis for greater than equal to (>/=) 12 months at Visit 1
* Bronchodilator response at Visit 1, 2, or 3
* Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
* On ICS therapy at a total daily dose of 500-2000 microgram (mcg) of fluticasone propionate dry powder inhaler (DPI) or equivalent for >/= 6 months prior to Visit 1
* On an eligible second controller medication (long-acting Beta-agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], or theophylline) for 6 months prior to Visit 1
* Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3
* Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) confirming the absence of other clinically significant lung disease
* Demonstrated adherence with controller medication during the screening period
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
* Maintenance oral corticosteroid therapy within 3 months of Visit 1
* Treatment with systemic (oral, intravenous [IV], or intramuscular [IM]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
* Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
* Infection requiring hospital admission for >/=24 hours or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
* Active tuberculosis requiring treatment within 12 months prior to Visit 1
* Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
* Evidence of acute or chronic hepatitis or known liver cirrhosis
* History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
* Known current malignancy or current evaluation for potential malignancy
* Current smoker or former smoker with a history of greater than (>) 10 pack-years
* History of alcohol or drug abuse
* Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
* Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening

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
31/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/01/2017
Sample size
Target
Accrual to date
Final
1068
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital; Department Thoracic Medicine - Sydney
Recruitment hospital [2] 0 0
AusTrials - Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine - Brisbane
Recruitment hospital [4] 0 0
Respiratory Clinical Trials Pty Ltd - Toorak Gardens
Recruitment hospital [5] 0 0
The Lung Institute of Western Australia; Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment postcode(s) [2] 0 0
4075 - Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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Kiev Governorate
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Inverness
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Sheffield
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United Kingdom
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Westbury-on-Trym, Bristol

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01868061