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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
Intravenous repeating dose
Intravenous repeating dose
The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo
Time frame: 16 weeks after the first dose
LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo
Time frame: Approximately Day 56 prior to third dose
Change in methacholine challenge response relative to the pre-allergen challenge PC20
Time frame: 24 hours after each allergen challenge
Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo
Time frame: Between 0 and 2 hours after each allergen challenge
Incidence and nature of treatment-emergent adverse events
Time frame: Through study completion or early study discontinuation
Incidence and nature of infusion reactions
Time frame: Through study completion or early study discontinuation
Incidence of infectious complications
Time frame: Through study completion or early study discontinuation
Incidence, nature, relatedness, and severity of adverse events
Time frame: Through study completion or early study discontinuation
Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures
Time frame: Through study completion or early study discontinuation
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Incidence of anti-therapeutic antibodies
Time frame: Through study completion or early study discontinuation