A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)

November 1, 2016 updated by: Genentech, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
578

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1056
      • Buenos Aires, Argentina, 1186
      • Ciudad Autónoma de Buenos Aires, Argentina, C1425BEN
      • Florencio Varela, Argentina, 1888
      • Mendoza, Argentina, 5500
      • Quilmes, Argentina, 1878
      • Rosario, Argentina, 2000
      • Salta, Argentina, 4400
      • San Miguel de Tucuman, Argentina, 4000
      • Tucuman, Argentina, 4000
  • Belgium
      • Gembloux, Belgium, 5030
      • Halen, Belgium, 3545
      • Leuven, Belgium, 3000
  • Bulgaria
      • Pleven, Bulgaria, 5800
      • Plovdiv, Bulgaria, 4003
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1336
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1680
      • Stara Zagora, Bulgaria, 6003
      • Varna, Bulgaria, 9010
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • Ontario
      • Mississauga, Ontario, Canada, L5A 3V4
      • Ottawa, Ontario, Canada, K1Y 4G2
      • Toronto, Ontario, Canada, M6H 3M2
      • Toronto, Ontario, Canada, M4V 1R2
      • Toronto, Ontario, Canada, M5T 3A9
  • Germany
      • Berlin, Germany, 10117
      • Berlin, Germany, 14050
      • Bochum, Germany, 44789
      • Coswig, Germany, 01640
      • Freiburg, Germany, 79106
      • Geesthacht, Germany, 21502
      • Jena, Germany, 07740
      • Landsberg, Germany, 86899
      • Magdeburg, Germany, 39120
      • Mainz, Germany, 55131
      • Muenster, Germany, 48149
  • Hungary
      • Balassagyarmat, Hungary, 2660
      • Debrecen, Hungary, 4031
      • Mosonmagyaróvar, Hungary, 9200
  • Mexico
      • Guadalajara, Mexico, 44130
      • Mexico, Mexico, 03100
      • Nuevo Leon, Mexico, 64710
  • New Zealand
      • Auckland, New Zealand, 1023
      • Aucklund, New Zealand, 2025
      • Christchurch, New Zealand, 8011
      • Dunedin, New Zealand
      • Hamilton, New Zealand
      • Wellington, New Zealand
  • Peru
      • Lima, Peru, Lima 27
      • Lima, Peru, Lima 33
      • Lima, Peru, 31
      • Lima, Peru, Lima 1
      • Lima, Peru, Lima 41
      • Lima, Peru, Lima 21
      • Lima, Peru, Lima 07
      • Miraflores, Peru, Lima 18
      • Piura, Peru, 20000
  • Poland
      • Bialystok, Poland, 15-276
      • Bialystok, Poland, 15-003
      • Bialystok, Poland, 15-010
      • Katowice, Poland, 40-752
      • Kielce, Poland, 25-734
      • Krakow, Poland, 31-023
      • Lublin, Poland, 20-552
      • Poznan, Poland, 60-214
      • Skierniewice, Poland, 96-100
      • Tarnow, Poland, 33-100
      • Warszawa, Poland, 01-868
      • Wroclaw, Poland, 54-239
  • Romania
      • Brasov, Romania, 16
      • Brasov, Romania, 500283
      • Bucharest, Romania, 050159
      • Bucuresti, Romania, 020125
      • Bucuresti, Romania, 011426
      • Cluj-Napoca, Romania, 400349
      • Craiova, Romania, 200515
      • Deva, Romania, 330084
  • Russian Federation
      • Moscow, Russian Federation, 117292
      • S. Petersburg, Russian Federation, 194291
      • Smolensk, Russian Federation, 214006
      • St Petersburg, Russian Federation, 193231
      • St. Petersburg, Russian Federation, 194354
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49000
      • Dnipropetrovsk, Ukraine, 49027
      • Dnipropetrovsk, Ukraine, 49066
      • Ivano-Frankivsk, Ukraine, 76018
      • Kiev, Ukraine, 03680
      • Kyiv, Ukraine, 02232
      • Kyiv, Ukraine, 03680
      • Lviv, Ukraine, 79010
      • Odessa, Ukraine, 65114
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
    • California
      • Bakersfield, California, United States, 93301
      • Costa Mesa, California, United States, 92626
      • Fountain Valley, California, United States, 92708
      • Long Beach, California, United States, 90808
      • Mission Viejo, California, United States, 92691
      • Rancho Cordova, California, United States, 95762
      • Redwood City, California, United States, 94063
      • Stockton, California, United States, 95207
      • Torrance, California, United States, 90505
      • Upland, California, United States, 91786
    • Colorado
      • Centennial, Colorado, United States, 80112
      • Denver, Colorado, United States, 80206
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Florida
      • Tampa, Florida, United States, 33613
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Albany, Georgia, United States, 31707
    • Idaho
      • Twin Falls, Idaho, United States, 83301
    • Illinois
      • Normal, Illinois, United States, 61761
      • River Forest, Illinois, United States, 60305
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Overland Park, Kansas, United States, 66210
    • Kentucky
      • Louisville, Kentucky, United States, 40223
    • Maryland
      • Baltimore, Maryland, United States, 21236
    • Missouri
      • Saint Louis, Missouri, United States, 63141
      • St Louis, Missouri, United States, 63141
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
      • Omaha, Nebraska, United States, 68130
    • New Jersey
      • Edison, New Jersey, United States, 08820
      • Teaneck, New Jersey, United States, 07666
    • New York
      • Bronx, New York, United States, 10461
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Canton, Ohio, United States, 44718
      • Centerville, Ohio, United States, 45458
      • Cincinnati, Ohio, United States, 45231
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
      • Tulsa, Oklahoma, United States, 74136
    • Oregon
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Pittsburgh, Pennsylvania, United States, 15241
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
      • Warwick, Rhode Island, United States, 02865
    • South Carolina
      • Charleston, South Carolina, United States, 29407
    • Texas
      • El Paso, Texas, United States, 79925
      • El Paso, Texas, United States, 79903
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78224
      • Waco, Texas, United States, 76712
    • Utah
      • Murray, Utah, United States, 84107
    • Virginia
      • Fairfax, Virginia, United States, 22030
    • Washington
      • Spokane, Washington, United States, 99204
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: placebo
Subcutaneous repeating dose
Experimental: MEMP1972A 150 mg
Drug: MEMP1972A
Subcutaneous repeating dose
Experimental: MEMP1972A 300 mg
Drug: MEMP1972A
Subcutaneous repeating dose
Experimental: MEMP1972A 450 mg
Drug: MEMP1972A
Subcutaneous repeating dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 36 weeks
36 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Relative change in pre-bronchodilator FEV1 (volume)
Time Frame: from baseline to Week 12
from baseline to Week 12
Relative change in FEV1 (volume)
Time Frame: from baseline to Week 36
from baseline to Week 36
Change in asthma symptoms
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in asthma symptoms
Time Frame: from baseline to Week 36
from baseline to Week 36
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
Time Frame: 12 weeks
12 weeks
Safety: Incidence of adverse events
Time Frame: 48 weeks
48 weeks
Incidence of anti-therapeutic antibodies (ATAs)
Time Frame: 84 weeks
84 weeks
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time Frame: Pre- and post-dose Weeks 0, 4, 12, 24 and 36
Pre- and post-dose Weeks 0, 4, 12, 24 and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GB27980
  • 2011-003997-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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