Clinical trial NCT01582503: A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 36 weeks
Secondary outcomes:
measure: Relative change in pre-bronchodilator FEV1 (volume)
timeFrame: from baseline to Week 12
measure: Relative change in FEV1 (volume)
timeFrame: from baseline to Week 36
measure: Change in asthma symptoms
timeFrame: from baseline to Week 12
measure: Change in asthma symptoms
timeFrame: from baseline to Week 36
measure: 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
timeFrame: 12 weeks
measure: Safety: Incidence of adverse events
timeFrame: 48 weeks
measure: Incidence of anti-therapeutic antibodies (ATAs)
timeFrame: 84 weeks
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: Pre- and post-dose Weeks 0, 4, 12, 24 and 36
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Bakersfield
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Rancho Cordova
country: United States
state: California
city: Redwood City
country: United States
state: California
city: Stockton
country: United States
state: California
city: Torrance
country: United States
state: California
city: Upland
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Tampa
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Albany
country: United States
state: Georgia
city: Twin Falls
country: United States
state: Idaho
city: Normal
country: United States
state: Illinois
city: River Forest
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Saint Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Bellevue
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Edison
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Centerville
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Warwick
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: El Paso
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Greenfield
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Ciudad Autónoma de Buenos Aires
country: Argentina
city: Florencio Varela
country: Argentina
city: Mendoza
country: Argentina
city: Quilmes
country: Argentina
city: Rosario
country: Argentina
city: Salta
country: Argentina
city: San Miguel de Tucuman
country: Argentina
city: Tucuman
country: Argentina
city: Gembloux
country: Belgium
city: Halen
country: Belgium
city: Leuven
country: Belgium
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Vancouver
country: Canada
state: British Columbia
city: Mississauga
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Coswig
country: Germany
city: Freiburg
country: Germany
city: Geesthacht
country: Germany
city: Jena
country: Germany
city: Landsberg
country: Germany
city: Magdeburg
country: Germany
city: Mainz
country: Germany
city: Muenster
country: Germany
city: Balassagyarmat
country: Hungary
city: Debrecen
country: Hungary
city: Mosonmagyaróvar
country: Hungary
city: Guadalajara
country: Mexico
city: Mexico
country: Mexico
city: Nuevo Leon
country: Mexico
city: Auckland
country: New Zealand
city: Aucklund
country: New Zealand
city: Christchurch
country: New Zealand
city: Dunedin
country: New Zealand
city: Hamilton
country: New Zealand
city: Wellington
country: New Zealand
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Miraflores
country: Peru
city: Piura
country: Peru
city: Bialystok
country: Poland
city: Bialystok
country: Poland
city: Bialystok
country: Poland
city: Katowice
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Skierniewice
country: Poland
city: Tarnow
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Brasov
country: Romania
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Deva
country: Romania
city: Moscow
country: Russian Federation
city: S. Petersburg
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Dnepropetrovsk
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.