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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

578

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

April 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 19, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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