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

Genentech

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Drug: huMAb OX40L

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00983658

OXF4696g

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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