asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Anti-M1 prime
Product Code: MEMP1972A (RO5541079)
Pharmaceutical Form: Solution for infusion
Current Sponsor code: MEMP1972A (RO5541079)
Other descriptive name: Anti-M1 prime
Concentrati
Sponsors
GENENTECH, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate whether MEMP1972A decreases the allergen-induced late airway response (LAR) after 12 weeks of exposure.;Secondary Objective: • To assess the safety and tolerability of MEMP1972A • To evaluate whether MEMP1972A decreases allergen-induced early airway response (EAR) after 12 weeks of exposure • To evaluate whether MEMP1972A decreases bronchial hyper-responsiveness in response to methacholine challenge 24 hours after the airway allergen challenge • To characterize the pharmacokinetics of MEMP1972A;Primary end point(s): The primary outcome measure is the LAR AUC (percent decline in FEV1 over time) between 3 and 7 hours after allergen challenge at 12 weeks (Day 86) after the first dose. The safety and tolerability of MEMP1972A will be assessed using the following measures: • Incidence and nature of treatment-emergent adverse events as well as incidence, nature, relatedness, and severity of adverse events • Incidence and nature of infusion reactions • Incidence of infectious complications • Clinically significant changes in vital signs, ECG, FEV1, and safety laboratory measures • Incidence of anti-therapeutic antibodies (ATA) | — |
Countries
Sweden
Outcome results
None listed