A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OFINTRAVENOUS MEMP1972A IN THE PREVENTION OF ALLERGEN-INDUCED AIRWAY OBSTRUCTION IN PATIENTS WITH MILD ASTHMA

• Conditions: asthma; MedDRA version: 12.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2010-021170-11-SE
• Lead Sponsor: GENENTECH, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-12
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Signed informed consent
• Men and women between 18 and 65 years old
• Weight between 50 and 125 kg
• 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 (excluding abstinence) against pregnancy through at least 5 months (predicted 5 half -lives of the study drug) following the last administration of study drug (see Appendix B for definitions of highly effective contraception)
• ECG at screening within normal limits as assessed by the study investigator
• Ability to comprehend and willingness to follow all required study procedures
• Methacholine challenge at screening must be documented to confirm a
diagnosis of asthma and provide a PC20 value for prediction of the starting
allergen concentration for inhalation in the screening test for responsiveness
to allergen.
• Positive skin prick test to common standard aeroallergens extracts
(e.g., ragweed, tree mix, grass mix, dog, cat, horse, feathers, dust mites)
• Positive allergen-induced early and late airway response
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• A worsening of asthma within 6 weeks preceding Visit 1
• Acute respiratory infection (including viral 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, including (but not limited to) parasitic infection
• 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, particularly coronary artery
disease, arrhythmias, hypertension, or congestive heart failure
• History or symptoms of significant neurologic disease, including transient
ischemic attack, stroke, seizure disorder, or behavioral disturbances
• History of significant hepatic or renal impairment
• Evidence of an active or suspected cancer or history of treatment for cancer
• History or symptoms of clinically significant autoimmune disease
• Any acquired or congenital immune deficiency
• Confirmed positive test for HIV or hepatitis B or C
• Concomitant disease or condition, which could interfere with the conduct
of the study, or for which the treatment might interfere with the conduct
of the study, or which would, in the opinion of the investigator, poses an
unacceptable risk to the patients in this study, including, but not limited to
cancer, alcoholism, drug dependency or abuse, or psychiatric disease
• History of serious adverse reaction or hypersensitivity to any drug
• Clinically significant abnormal chest radiograph within the last 12 months
• Clinically significant abnormalities in laboratory test results (including complete
blood count, coagulation, serum chemistry panel, and urinalysis)
• Pregnancy or lactation or positive serum pregnancy test at screening
• Use of corticosteroids (oral, systemic or inhaled), immunosuppressives,
anticoagulants (warfarin or heparin), or any medications that may interact
with study drug within 4 weeks prior to Visit 2
• Chronic use of any other medication for treatment of allergic lung disease
other than short-acting ß2-agonists or ipratropium bromide
• Use of cromoglycate, nedocromil, leukotriene receptor antagonists
(zafirlukast, pranlukast, montelukast), and inhibitors of 5-lipoxygenase
(zileuton) are not permitted within 4 weeks prior to Visit 2
• Allergen or peptide immunotherapy within 6 months prior to Visit 1
• Participation in any other investigational drug study within the preceding
30 days or 5 half-lives of that drug, whichever is longer at the time of Visit 2
• Current (or history of) treatment with a monoclonal antibody or
chimeric biomolecule within the past 5 months (5 half-lives of the drug),
including omalizumab, at the time of Visit 2
• Use of statins are not permitted within 4 weeks prior to Visit 2
• Received live or attenuated vaccine (including but not limited to FluMist-brand influenza vaccine, MMR (measles, mumps, rubella), VZV (varicella zoster/chickenpox), oral polio, etc. within 30 days prior to Visit 5
• Regular use of tobacco products of any kind or within the previous 6 months,
or smoking history > 10 pack-years
• History of drug or alcohol abuse, which, in the judgment of the investigator,
may put the patient at risk for being unable to participate ful

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified