Clinical trial NCT00983658: A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Anti-OX40L
Mild Allergic Asthma
Allergies
Allergic Asthma
Adult Asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo
timeFrame: 16 weeks after the first dose
Secondary outcomes:
measure: LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo
timeFrame: Approximately Day 56 prior to third dose
measure: Change in methacholine challenge response relative to the pre-allergen challenge PC20
timeFrame: 24 hours after each allergen challenge
measure: Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo
timeFrame: Between 0 and 2 hours after each allergen challenge
measure: Incidence and nature of treatment-emergent adverse events
timeFrame: Through study completion or early study discontinuation
measure: Incidence and nature of infusion reactions
timeFrame: Through study completion or early study discontinuation
measure: Incidence of infectious complications
timeFrame: Through study completion or early study discontinuation
measure: Incidence, nature, relatedness, and severity of adverse events
timeFrame: Through study completion or early study discontinuation
measure: Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures
timeFrame: Through study completion or early study discontinuation
measure: Incidence of anti-therapeutic antibodies
timeFrame: Through study completion or early study discontinuation
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Dana McClintock, M.D.
role: STUDY_DIRECTOR
References:
citation: Gauvreau GM, Boulet LP, Cockcroft DW, FitzGerald JM, Mayers I, Carlsten C, Laviolette M, Killian KJ, Davis BE, Larche M, Kipling C, Dua B, Mosesova S, Putnam W, Zheng Y, Scheerens H, McClintock D, Matthews JG, O'Byrne PM. OX40L blockade and allergen-induced airway responses in subjects with mild asthma. Clin Exp Allergy. 2014 Jan;44(1):29-37. doi: 10.1111/cea.12235.