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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: MEMP1972A; Drug: placebo

• Registration Number: NCT01582503
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Primary Completion: 2014-05
• Study Completion: 2014-11
• Disposition First Submitted: 2016-08-09
• Disposition First Submitted QC: 2016-08-09
• Disposition First Posted: 2016-08-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 578

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEMP1972A 150 mg	MEMP1972A	-
MEMP1972A 450 mg	MEMP1972A	-
MEMP1972A 300 mg	MEMP1972A	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
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	36 weeks

Secondary Outcome Measures

Name	Time	Method
Relative change in pre-bronchodilator FEV1 (volume)	from baseline to Week 12
Relative change in FEV1 (volume)	from baseline to Week 36
Change in asthma symptoms	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	12 weeks
Safety: Incidence of adverse events	48 weeks
Incidence of anti-therapeutic antibodies (ATAs)	84 weeks
Pharmacokinetics: Area under the concentration-time curve (AUC)	Pre- and post-dose Weeks 0, 4, 12, 24 and 36