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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
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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
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Secondary ID [1]
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2013-000176-15
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Secondary ID [2]
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GB28689
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period
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Assessment method [1]
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Timepoint [1]
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Baseline up to Week 52
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Secondary outcome [1]
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Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
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Assessment method [1]
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Timepoint [1]
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Baseline, Week 52
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Secondary outcome [2]
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Time to First Asthma Exacerbation
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Assessment method [2]
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Timepoint [2]
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Baseline up to Week 52
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Secondary outcome [3]
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Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score
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Assessment method [3]
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Timepoint [3]
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Baseline, Week 52
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Secondary outcome [4]
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Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments)
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Assessment method [4]
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Timepoint [4]
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Baseline, Week 52
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Secondary outcome [5]
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Rate of Urgent Asthma-Related Urgent Health Care Utilization
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Assessment method [5]
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Timepoint [5]
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Baseline up to Week 52
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Secondary outcome [6]
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Percentage of Participants With Adverse Events
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Assessment method [6]
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Timepoint [6]
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Baseline up to Week 124
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Secondary outcome [7]
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Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab
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Assessment method [7]
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Timepoint [7]
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Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124)
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Secondary outcome [8]
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Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score
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Assessment method [8]
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Timepoint [8]
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Baseline, Week 52
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Secondary outcome [9]
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Minimum Serum Concentration (Cmin) of Lebrikizumab
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Assessment method [9]
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Timepoint [9]
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Predose (0 hour) on Weeks 4, 12, 24, 36, and 52
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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
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Minimum age
18
Years
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/01/2017
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Sample size
Target
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Accrual to date
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Final
1068
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital; Department Thoracic Medicine - Sydney
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AusTrials - Brisbane
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Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine - Brisbane
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Recruitment hospital [4]
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Respiratory Clinical Trials Pty Ltd - Toorak Gardens
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Recruitment hospital [5]
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The Lung Institute of Western Australia; Sir Charles Gairdner Hospital - Nedlands
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2139 - Sydney
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Recruitment postcode(s) [2]
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4075 - Brisbane
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4102 - Brisbane
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5065 - Toorak Gardens
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6009 - Nedlands
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Recruitment outside Australia
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Russian Federation
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Novosibirsk
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Russian Federation
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Penza
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Russian Federation
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Ryazan
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Russian Federation
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Saratov
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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Sremska Kamenica
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Serbia
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Zemun
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Slovakia
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Bratislava
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Slovakia
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Levice
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Slovakia
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Nitra
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Tabazimbi
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South Africa
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Umkomaas
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South Africa
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Worcester
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Spain
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La Coruña
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Spain
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Madrid
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Spain
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Sevilla
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Alicante
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Spain
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Barcelona
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Spain
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Girona
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Ukraine
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Kiev Governorate
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Ukraine
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Cherkasy
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Mykolaiv
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Ukraine
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Odesa
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Ukraine
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Poltava
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhia
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Ukraine
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Zaporizhzhye
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United Kingdom
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Inverness
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United Kingdom
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Preston
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United Kingdom
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Sheffield
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United Kingdom
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Westbury-on-Trym, Bristol
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Funding & Sponsors
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Commercial sector/industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection 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. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
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Trial website
https://clinicaltrials.gov/study/NCT01868061
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Trial related presentations / publications
Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7. N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019. Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.
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Public notes
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Contacts
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Clinical Trials
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Hoffmann-La Roche
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What supporting documents are/will be available?
No Supporting Document Provided
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Results not provided in
https://clinicaltrials.gov/study/NCT01868061
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