Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01582503




Registration number
NCT01582503
Ethics application status
Date submitted
19/04/2012
Date registered
20/04/2012
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)
Scientific title
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)
Secondary ID [1] 0 0
2011-003997-10
Secondary ID [2] 0 0
GB27980
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 - MEMP1972A
Treatment: Drugs - MEMP1972A
Treatment: Drugs - MEMP1972A
Treatment: Drugs - placebo

Experimental: MEMP1972A 150 mg -

Experimental: MEMP1972A 300 mg -

Experimental: MEMP1972A 450 mg -

Placebo comparator: Placebo -


Treatment: Drugs: MEMP1972A
Subcutaneous repeating dose

Treatment: Drugs: MEMP1972A
Subcutaneous repeating dose

Treatment: Drugs: MEMP1972A
Subcutaneous repeating dose

Treatment: Drugs: placebo
Subcutaneous repeating dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36
Timepoint [1] 0 0
36 weeks
Secondary outcome [1] 0 0
Relative change in pre-bronchodilator FEV1 (volume)
Timepoint [1] 0 0
from baseline to Week 12
Secondary outcome [2] 0 0
Relative change in FEV1 (volume)
Timepoint [2] 0 0
from baseline to Week 36
Secondary outcome [3] 0 0
Change in asthma symptoms
Timepoint [3] 0 0
from baseline to Week 12
Secondary outcome [4] 0 0
Change in asthma symptoms
Timepoint [4] 0 0
from baseline to Week 36
Secondary outcome [5] 0 0
Proportion of "well-controlled" weeks (no nighttime awakenings due to asthma symptoms and </= 2 days of SABA use per weeks, as documented by patient diary) from Week 24 to Week 36
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Safety: Incidence of adverse events
Timepoint [6] 0 0
48 weeks
Secondary outcome [7] 0 0
Incidence of anti-therapeutic antibodies (ATAs)
Timepoint [7] 0 0
84 weeks
Secondary outcome [8] 0 0
Pharmacokinetics: Area under the concentration-time curve (AUC)
Timepoint [8] 0 0
Pre- and post-dose Weeks 0, 4, 12, 24 and 36

Eligibility
Key inclusion criteria
* Adult patients, 18 to 75 years of age inclusive
* Body weight >/= 40 kg
* Physician's diagnosis of asthma for at least 12 months
* Evidence of documented bronchodilator reversibility as defined by protocol
* Prebronchodilator FEV1 >/= 40% and </= 80% predicted at Visit 1
* Required daily use of ICS and a second controller for a minimum of 3 consecutive months prior to Visit 1
* History of at least one protocol-defined asthma exacerbation in the 18 months prior to Visit 1
* Inadequately controlled asthma despite compliance with asthma controller therapy
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Asthma exacerbation requiring systemic steroids in the 30 days prior to Visit 1
* Pre-existing active lung disease other than asthma
* Any infection
* Clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology
* Known immunodeficiency, including but not limited to HIV infection, regardless of treatment status
* Current substance abuse
* Former smoker with >10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to Visit 1
* History of anaphylaxis
* Pregnant and lactating women

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
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
578
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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Colorado
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Connecticut
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Florida
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United States of America
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Georgia
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Idaho
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United States of America
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Illinois
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Iowa
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Kansas
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Kentucky
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Maryland
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Missouri
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Florencio Varela
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Argentina
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Mendoza
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Argentina
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Quilmes
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Argentina
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Rosario
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Argentina
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Salta
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Argentina
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San Miguel de Tucuman
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Argentina
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Tucuman
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Belgium
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Gembloux
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Belgium
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Halen
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Belgium
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Leuven
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Bulgaria
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Varna
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Canada
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British Columbia
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Canada
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Ontario
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Coswig
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Germany
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Freiburg
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Germany
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Geesthacht
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Germany
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Jena
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Germany
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Landsberg
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Muenster
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Hungary
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Balassagyarmat
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Hungary
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Debrecen
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Hungary
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Mosonmagyaróvar
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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Nuevo Leon
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New Zealand
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Auckland
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New Zealand
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Aucklund
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Wellington
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Peru
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Lima
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Peru
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Miraflores
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Peru
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Piura
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Bialystok
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Katowice
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Kielce
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Krakow
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Lublin
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Poznan
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Skierniewice
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Tarnow
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Warszawa
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Poland
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Wroclaw
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Deva
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Russian Federation
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Moscow
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Russian Federation
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S. Petersburg
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Russian Federation
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Smolensk
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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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Ukraine
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Dnepropetrovsk
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Ukraine
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Dnipropetrovsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
State/province [100] 0 0
Lviv
Country [101] 0 0
Ukraine
State/province [101] 0 0
Odessa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
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
Genentech, Inc.
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/NCT01582503