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

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582503
• Other study ID #: GB27980
• Secondary ID: 2011-003997-10
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2012
• Last updated: November 1, 2016
• Start date: April 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• MEMP1972A
Subcutaneous repeating dose
• MEMP1972A
Subcutaneous repeating dose
• MEMP1972A
Subcutaneous repeating dose
• placebo
Subcutaneous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  Canada,  Germany,  Hungary,  Mexico,  New Zealand,  Peru,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

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