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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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Romania
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Brasov
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Lviv
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Odessa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety
of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately
controlled on chronic therapy with high dose inhaled corticosteroids and a second controller
medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of
either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual
asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with
a 48-week follow-up.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01582503
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01582503