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

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: MEMP1972A Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Asthma Steroids

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative change in pre-bronchodilator FEV1 (volume) [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
Relative change in FEV1 (volume) [ Time Frame: from baseline to Week 36 ] [ Designated as safety issue: No ]
Change in asthma symptoms [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
Change in asthma symptoms [ Time Frame: from baseline to Week 36 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Incidence of anti-therapeutic antibodies (ATAs) [ Time Frame: 84 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre- and post-dose Weeks 0, 4, 12, 24 and 36 ] [ Designated as safety issue: No ]

Estimated Enrollment:	560
Study Start Date:	April 2012
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MEMP1972A 300 mg	Drug: MEMP1972A Subcutaneous repeating dose
Experimental: MEMP1972A 150 mg	Drug: MEMP1972A Subcutaneous repeating dose
Experimental: MEMP1972A 450 mg	Drug: MEMP1972A Subcutaneous repeating dose
Placebo Comparator: Placebo	Drug: placebo Subcutaneous repeating dose

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582503

Contacts

Contact: Please reference Study ID Number: GB27980 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 159 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Clinical Trials

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01582503 History of Changes
Other Study ID Numbers:	GB27980, 2011-003997-10
Study First Received:	April 19, 2012
Last Updated:	April 1, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013