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AsthmaPhase 2NCT01582503

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

A Phase 2 study testing MEMP1972A in people with Asthma, run by Genentech, Inc. at 145 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
MEMP1972A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
578 participants
Where
145 sitesin 14 countries
Study dates
Apr 2012to Nov 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

145 sites in 14 countries.

145 sites in 14 countries

United States51 sites

  • Study site

    Albany, Georgia, 31707

  • Study site

    Bakersfield, California, 93301

  • Study site

    Baltimore, Maryland, 21236

  • Study site

    Bellevue, Nebraska, 68123

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Canton, Ohio, 44718

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Centerville, Ohio, 45458

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Cincinnati, Ohio, 45231

  • Study site

    Costa Mesa, California, 92626

  • Study site

    Denver, Colorado, 80206

  • Study site

    Edison, New Jersey, 08820

  • Study site

    El Paso, Texas, 79903

  • Study site

    El Paso, Texas, 79925

  • Study site

    Fairfax, Virginia, 22030

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Greenfield, Wisconsin, 53228

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Long Beach, California, 90808

  • Study site

    Louisville, Kentucky, 40223

  • Study site

    Medford, Oregon, 97504

  • Study site

    Mission Viejo, California, 92691

  • Study site

    Murray, Utah, 84107

  • Study site

    New Haven, Connecticut, 06510

  • Study site

    Normal, Illinois, 61761

  • Study site

    Oklahoma City, Oklahoma, 73120

  • Study site

    Omaha, Nebraska, 68130

  • Study site

    Overland Park, Kansas, 66210

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Pittsburgh, Pennsylvania, 15241

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Rancho Cordova, California, 95762

  • Study site

    Redwood City, California, 94063

  • Study site

    River Forest, Illinois, 60305

  • Study site

    San Antonio, Texas, 78224

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stockton, California, 95207

  • Study site

    Tampa, Florida, 33613

  • Study site

    Teaneck, New Jersey, 07666

  • Study site

    The Bronx, New York, 10461

  • Study site

    Torrance, California, 90505

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Twin Falls, Idaho, 83301

  • Study site

    Upland, California, 91786

  • Study site

    Waco, Texas, 76712

  • Study site

    Warwick, Rhode Island, 02865

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winter Park, Florida, 32789

Other trials in United States

Poland12 sites

  • Study site

    Bialystok, 15-003

  • Study site

    Bialystok, 15-010

  • Study site

    Bialystok, 15-276

  • Study site

    Katowice, 40-752

  • Study site

    Kielce, 25-734

  • Study site

    Krakow, 31-023

  • Study site

    Lublin, 20-552

  • Study site

    Poznan, 60-214

  • Study site

    Skierniewice, 96-100

  • Study site

    Tarnów, 33-100

  • Study site

    Warsaw, 01-868

  • Study site

    Wroclaw, 54-239

Other trials in Poland

Germany11 sites

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 14050

  • Study site

    Bochum, 44789

  • Study site

    Coswig, 01640

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Geesthacht, 21502

  • Study site

    Jena, 07740

  • Study site

    Landsberg, 86899

  • Study site

    Magdeburg, 39120

  • Study site

    Mainz, 55131

  • Study site

    Münster, 48149

Other trials in Germany

Bulgaria10 sites

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4003

  • Study site

    Rousse, 7002

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1336

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1606

  • Study site

    Sofia, 1680

  • Study site

    Stara Zagora, 6003

  • Study site

    Varna, 9010

Other trials in Bulgaria

Argentina9 sites

  • Study site

    Buenos Aires, 1056

  • Study site

    Buenos Aires, 1186

  • Study site

    Buenos Aires, C1425BEN

  • Study site

    Mendoza, 5500

  • Study site

    Quilmes, 1878

  • Study site

    Rosario, 2000

  • Study site

    Salta, 4400

  • Study site

    San Juan Bautista, 1888

  • Study site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Peru9 sites

  • Study site

    Lima, 31

  • Study site

    Lima, Lima 07

  • Study site

    Lima, Lima 1

  • Study site

    Lima, Lima 21

  • Study site

    Lima, Lima 27

  • Study site

    Lima, Lima 33

  • Study site

    Lima, Lima 41

  • Study site

    Miraflores, Lima 18

  • Study site

    Piura, 20000

Other trials in Peru

Ukraine9 sites

  • Study site

    Dnipro, 49000

  • Study site

    Dnipropetrovsk, 49027

  • Study site

    Dnipropetrovsk, 49066

  • Study site

    Ivano-Frankivsk, 76018

  • Study site

    Kiev, 03680

  • Study site

    Kyiv, 02232

  • Study site

    Kyiv, 03680

  • Study site

    Lviv, 79010

  • Study site

    Odesa, 65114

Other trials in Ukraine

Romania8 sites

  • Study site

    Brasov, 16

  • Study site

    Brasov, 500283

  • Study site

    Bucharest, 011426

  • Study site

    Bucharest, 020125

  • Study site

    Bucharest, 050159

  • Study site

    Cluj-Napoca, 400349

  • Study site

    Craiova, 200515

  • Study site

    Deva, 330084

Other trials in Romania

Canada6 sites

  • Study site

    Mississauga, Ontario, L5A 3V4

  • Study site

    Ottawa, Ontario, K1Y 4G2

  • Study site

    Toronto, Ontario, M4V 1R2

  • Study site

    Toronto, Ontario, M5T 3A9

  • Study site

    Toronto, Ontario, M6H 3M2

  • Study site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

New Zealand6 sites

  • Study site

    Auckland, 1023

  • Study site

    Aucklund, 2025

  • Study site

    Christchurch, 8011

  • Study site

    Dunedin

  • Study site

    Hamilton

  • Study site

    Wellington

Other trials in New Zealand

Russia5 sites

  • Study site

    Moscow, 117292

  • Study site

    S. Petersburg, 194291

  • Study site

    Saint Petersburg, 193231

  • Study site

    Saint Petersburg, 194354

  • Study site

    Smolensk, 214006

Other trials in Russia

Belgium3 sites

  • Study site

    Gembloux, 5030

  • Study site

    Halen, 3545

  • Study site

    Leuven, 3000

Other trials in Belgium

Hungary3 sites

  • Study site

    Balassagyarmat, 2660

  • Study site

    Debrecen, 4031

  • Study site

    Mosonmagyaróvar, 9200

Other trials in Hungary

Mexico3 sites

  • Study site

    Guadalajara, 44130

  • Study site

    México, 03100

  • Study site

    Nuevo León, 64710

Other trials in Mexico

About this study

Official 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)

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.

Conditions
Asthma
Being tested
MEMP1972A, placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEMP1972ADrug

    Subcutaneous repeating dose

  • MEMP1972ADrug

    Subcutaneous repeating dose

  • MEMP1972ADrug

    Subcutaneous repeating dose

  • placeboDrug

    Subcutaneous repeating dose

Study groups in NCT01582503
Study groupRoleWhat they receive
MEMP1972A 150 mgExperimentalNot described
Receives: Drug: MEMP1972A
MEMP1972A 300 mgExperimentalNot described
Receives: Drug: MEMP1972A
MEMP1972A 450 mgExperimentalNot described
Receives: Drug: MEMP1972A
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 36 weeks

Secondary outcomes (8)

  1. Relative change in pre-bronchodilator FEV1 (volume)

    Measured: from baseline to Week 12

  2. Relative change in FEV1 (volume)

    Measured: from baseline to Week 36

  3. Change in asthma symptoms

    Measured: from baseline to Week 12

  4. Change in asthma symptoms

    Measured: from baseline to Week 36

  5. 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

    Measured: 12 weeks

  6. Safety: Incidence of adverse events

    Measured: 48 weeks

  7. Incidence of anti-therapeutic antibodies (ATAs)

    Measured: 84 weeks

  8. Pharmacokinetics: Area under the concentration-time curve (AUC)

    Measured: Pre- and post-dose Weeks 0, 4, 12, 24 and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionMay 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
578 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01582503
Sponsor's protocol ID
GB27980
Other IDs
2011-003997-10
Status last verified
Nov 2016
First submitted
19 Apr 2012
Last updated
2 Nov 2016
Results posted
No

Publications

  • Harris JM, Maciuca R, Bradley MS, Cabanski CR, Scheerens H, Lim J, Cai F, Kishnani M, Liao XC, Samineni D, Zhu R, Cochran C, Soong W, Diaz JD, Perin P, Tsukayama M, Dimov D, Agache I, Kelsen SG. A randomized trial of the efficacy and safety of quilizumab in adults with inadequately controlled allergic asthma. Respir Res. 2016 Mar 18;17:29. doi: 10.1186/s12931-016-0347-2.

    PubMed 26993628

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEMP1972A in people with Asthma, run by Genentech, Inc. at 145 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Poland, Germany, Bulgaria, Argentina and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01582503, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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