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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous huMAb OX40L (RO4989991) in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: huMAb OX40L
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: huMAb OX40L<br> | Drug: huMAb OX40L<br>* Intravenous repeating dose<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Intravenous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo |  | 16 weeks after the first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo |  | Approximately Day 56 prior to third dose | 
| Change in methacholine challenge response relative to the pre-allergen challenge PC20 |  | 24 hours after each allergen challenge | 
| Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo |  | Between 0 and 2 hours after each allergen challenge | 
| Incidence and nature of treatment-emergent adverse events |  | Through study completion or early study discontinuation | 
| Incidence and nature of infusion reactions |  | Through study completion or early study discontinuation | 
| Incidence of infectious complications |  | Through study completion or early study discontinuation | 
| Incidence, nature, relatedness, and severity of adverse events |  | Through study completion or early study discontinuation | 
| Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures |  | Through study completion or early study discontinuation | 
| Incidence of anti-therapeutic antibodies |  | Through study completion or early study discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-OX40L, Mild Allergic Asthma, Allergies, Allergic Asthma, Adult Asthma