A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma

Genentech, Inc.0 sites29 target enrollmentDecember 2010

ConditionsAsthma

InterventionsMEMP1972A placebo

Overview

Phase: Phase 2
Intervention: MEMP1972A
Conditions: Asthma
Sponsor: Genentech, Inc.
Enrollment: 29
Primary Endpoint: Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to patients by intravenous (IV) infusion for the treatment of allergen-induced asthma.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

January 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Mild, stable allergic asthma
•History of episodic wheeze and shortness of breath
•FEV1 at baseline \>= 70% of the predicted value
•Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 5 months following the last administration of study drug
•Documented PC20 value for prediction of the starting allergen concentration at screening
•Positive skin prick test to common standard aeroallergens extracts
•Positive allergen-induced early and late airway response

Exclusion Criteria

•A worsening of asthma within 6 weeks preceding Visit 1
•Acute respiratory infection within 6 weeks preceding Visit 2 or any ongoing chronic infection
•History of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition
•Risk of exposure, as determined by the investigator, to water-borne parasites or clinical diagnosis of parasitic infection that is untreated within 3 months prior to Visit 5
•Lung disease other than mild allergic asthma
•History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
•History or symptoms of cardiovascular disease
•History or symptoms of significant neurologic disease
•History of significant hepatic or renal impairment
•Evidence of an active or suspected cancer or history of treatment for cancer

Arms & Interventions

A

Intervention: MEMP1972A

B

Intervention: placebo

Outcomes

Primary Outcomes

Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time)

Time Frame: Between 3 and 7 hours after allergen challenge at Day 86 after the first dose

Secondary Outcomes

Maximum percent decline in FEV1(Immediately prior to the allergen challenge to between 3 and 7 hours after allergen challenge on Day 86 after the first dose)
Change in methacholine challenge PC20 relative to the pre-allergen challenge PC20(Day 87)
Maximum percent decline in FEV1 and early airway response (EAR) AUC (percent decline in FEV1 over time)(Between 0 and 3 hours after post-treatment allergen challenge)