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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01987492




Registration number
NCT01987492
Ethics application status
Date submitted
12/11/2013
Date registered
19/11/2013
Date last updated
22/05/2017

Titles & IDs
Public title
A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
Scientific title
A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma
Secondary ID [1] 0 0
2012-000190-24
Secondary ID [2] 0 0
WB28182
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 High Dose - Participants will receive lebrikizumab at high dose level as subcutaneous (SC) injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.

Experimental: Lebrikizumab Low Dose - Participants will receive lebrikizumab at low dose level as SC injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.

Placebo comparator: Placebo - Participants will receive placebo matching to lebrikizumab SC injection every 4 weeks during the 44-week DBPC period. Participants will then be randomized to receive either high- or low-dose lebrikizumab every 4 weeks during the 32-week ATE period and will continue same treatment in the LTE period.


Treatment: Drugs: Lebrikizumab
Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.

Treatment: Drugs: Placebo
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relative Change From Baseline in Daily OCS Dose at Week 44
Timepoint [1] 0 0
Baseline, Week 44
Secondary outcome [1] 0 0
Absolute Change From Baseline in Daily OCS Dose at Week 44
Timepoint [1] 0 0
Baseline, Week 44
Secondary outcome [2] 0 0
Relative Change From Week 12 in Average OCS Dose at Week 44
Timepoint [2] 0 0
Week 12, Week 44
Secondary outcome [3] 0 0
Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline
Timepoint [3] 0 0
Baseline, Week 44
Secondary outcome [4] 0 0
Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44
Timepoint [4] 0 0
Week 44
Secondary outcome [5] 0 0
Percentage of Participants With Asthma Exacerbations
Timepoint [5] 0 0
Baseline up to Week 44
Secondary outcome [6] 0 0
Percentage of Participants With Adverse Events
Timepoint [6] 0 0
Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)
Secondary outcome [7] 0 0
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Lebrikizumab
Timepoint [7] 0 0
Predose (0 hours) at Weeks 0, 4, 12, 24, 36, 44, 52, 64, and 76, at early discontinuation (up to a minimum of approximately 2 years), and at 24 weeks after last dose administration (up to a minimum of approximately 2 years)
Secondary outcome [8] 0 0
Minimum Observed Serum Lebrikizumab Concentration (Cmin)
Timepoint [8] 0 0
Predose (0 hours) at Weeks 4, 12, 24, 36, and 44

Eligibility
Key inclusion criteria
* Severe asthma despite intensive follow-up by an asthma specialist for >/=6 months prior to Visit 1
* Baseline forced expiratory volume in 1 second (FEV1) >/=40% of predicted prior to randomization
* Receiving high doses of inhaled glucocorticosteroids at a total daily dose of >/=1500 micrograms (mcg) beclomethasone dipropionate or equivalent and long-acting beta-adrenoceptor agonist (LABA), with or without an additional controller, for at least 3 months prior to Visit 1
* Chronic treatment with maintenance OCS for >/=6 months prior to Visit 1
* Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
* Asthma exacerbation within 28 days prior to Visit 1 or during screening (prior to Visit 3)
* For adults: Active tuberculosis requiring treatment within the 12 months prior to Visit 1
* For adolescents: History of active tuberculosis requiring treatment
* Evidence of acute or chronic hepatitis or known liver cirrhosis
* Known current malignancy or current evaluation for a potential malignancy
* History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
* Infection requiring hospital admission or requiring treatment with intravenous (IV) or intramuscular (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
* Current smoker or former smoker with a smoking history of more than 15 pack-years
* Current use of an immunomodulatory/ immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to Visit 1
* Use of a licensed or investigational monoclonal antibody other than anti-interleukin (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 (whichever is longer) prior to Visit 1
* Receipt of a live attenuated vaccine within the 4 weeks prior to Visit 1 during screening or anticipation of receipt of a live attenuated vaccine throughout the study

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 2
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
28/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2016
Sample size
Target
Accrual to date
Final
230
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine - Brisbane
Recruitment hospital [2] 0 0
Monash Medical Centre; Respiratory and Sleep Medicine - Clayton
Recruitment hospital [3] 0 0
Institute for Respiratory Health Inc - Nedlands
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oklahoma
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Belgium
State/province [8] 0 0
Bruxelles
Country [9] 0 0
Belgium
State/province [9] 0 0
Genk
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Czechia
State/province [12] 0 0
Brno
Country [13] 0 0
Czechia
State/province [13] 0 0
Liberec 1
Country [14] 0 0
Czechia
State/province [14] 0 0
Nový Jicín
Country [15] 0 0
Czechia
State/province [15] 0 0
Rokycany
Country [16] 0 0
Denmark
State/province [16] 0 0
Hellerup
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France
State/province [17] 0 0
Grenoble Cedex 9
Country [18] 0 0
France
State/province [18] 0 0
Le Kremlin Bicetre
Country [19] 0 0
France
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Lyon
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France
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Montpellier
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France
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Nantes
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France
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Nice Cedex 1
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Pessac
Country [25] 0 0
France
State/province [25] 0 0
Strabourg
Country [26] 0 0
Mexico
State/province [26] 0 0
Guadalajara
Country [27] 0 0
Mexico
State/province [27] 0 0
Querétaro
Country [28] 0 0
Netherlands
State/province [28] 0 0
Amsterdam
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Netherlands
State/province [29] 0 0
Hoofddorp
Country [30] 0 0
Netherlands
State/province [30] 0 0
Nieuwegein
Country [31] 0 0
New Zealand
State/province [31] 0 0
Auckland
Country [32] 0 0
New Zealand
State/province [32] 0 0
Dunedin
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New Zealand
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Tauranga
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New Zealand
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Wellington
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Ostrow Wielkopolski
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Poland
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Ruda Slaska
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Poland
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Warszawa
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Poland
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Wroclaw
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Puerto Rico
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Caguas
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Puerto Rico
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Cidra
Country [43] 0 0
Slovakia
State/province [43] 0 0
Levice
Country [44] 0 0
Slovakia
State/province [44] 0 0
Spisska Nova Ves
Country [45] 0 0
Slovenia
State/province [45] 0 0
Golnik
Country [46] 0 0
Spain
State/province [46] 0 0
La Coruña
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
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Salamanca
Country [49] 0 0
Spain
State/province [49] 0 0
Valencia
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Belfast
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Birmingham
Country [52] 0 0
United Kingdom
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Glasgow
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United Kingdom
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Hampshire
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Leicester
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United Kingdom
State/province [55] 0 0
London
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United Kingdom
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Manchester
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United Kingdom
State/province [57] 0 0
Newcastle upon Tyne
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Plymouth
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Sheffield

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/NCT01987492