Asthma
Conditions
Keywords
Anti-OX40L, Mild Allergic Asthma, Allergies, Allergic Asthma, Adult Asthma
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 for the treatment of allergen-induced asthma.
Interventions
DRUGhuMAb OX40L
Intravenous repeating dose
DRUGplacebo
Intravenous repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Contacts
STUDY_DIRECTORDana McClintock, M.D.
Genentech, Inc.
Outcome results
None listed