Status:
COMPLETED
A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Lead Sponsor:
Genentech, Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by IV infusion ...
Eligibility Criteria
Inclusion
- 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
- For women of childbearing potential, agreement to use an effective means of contraception while enrolled in the study
- For men with partners of childbearing potential, willingness to use condoms with spermicide during treatment
- Ability to comprehend and follow all required study procedures
- Positive skin prick test to common aeroallergens (e.g., cat, dust, mite, grass, and pollen)
- Positive allergen-induced early and late airway bronchoconstriction
Exclusion
- A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
- Acute infection (including viral infection) within the 6 weeks preceding dosing (8 weeks for respiratory infections) 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), tuberculosis, parasitic infection, etc.
- Lung disease other than mild allergic asthma
- History of heart, lung, kidney, liver, neurologic or chronic infectious disease
- Concomitant disease or condition, which could interfere with the conduct of the 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
- Pregnancy or lactation or positive serum pregnancy test at screening
- Chronic use of any other medication for treatment of allergic lung disease other than short-acting β2-agonists or ipratropium bromide
- 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
- Regular use of tobacco products of any kind or within the previous 6 months, or smoking history \> 10 pack-years
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00983658
Start Date
September 1 2009
End Date
January 1 2011
Last Update
August 2 2016
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