A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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 for the treatment of allergen-induced asthma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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