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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01582503
First received: April 19, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This randomized, double-blind, placebo-controlled study will evaluate the effica cy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled co rticosteroids 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 th roughout the study. Anticipated time on study treatment is 36 weeks, with a 48-w eek follow-up.


Condition Intervention Phase
Asthma
Drug: placebo
Drug: MEMP1972A
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:


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 ]

Enrollment: 578
Study Start Date: April 2012
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 147 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: August 4, 2014
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 August 27, 2014