Back to resultsA Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
huMAb OX40L
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Anti-OX40L, Mild Allergic Asthma, Allergies, Allergic Asthma, Adult 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
huMAb OX40L
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo
Secondary Outcome Measures
LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo
Change in methacholine challenge response relative to the pre-allergen challenge PC20
Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo
Incidence and nature of treatment-emergent adverse events
Incidence and nature of infusion reactions
Incidence of infectious complications
Incidence, nature, relatedness, and severity of adverse events
Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures
Incidence of anti-therapeutic antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00983658
Brief Title
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
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Anti-OX40L, Mild Allergic Asthma, Allergies, Allergic Asthma, Adult Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
huMAb OX40L
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
huMAb OX40L
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo
Time Frame
Approximately Day 56 prior to third dose
Title
Change in methacholine challenge response relative to the pre-allergen challenge PC20
Time Frame
24 hours after each allergen challenge
Title
Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo
Time Frame
Between 0 and 2 hours after each allergen challenge
Title
Incidence and nature of treatment-emergent adverse events
Time Frame
Through study completion or early study discontinuation
Title
Incidence and nature of infusion reactions
Time Frame
Through study completion or early study discontinuation
Title
Incidence of infectious complications
Time Frame
Through study completion or early study discontinuation
Title
Incidence, nature, relatedness, and severity of adverse events
Time Frame
Through study completion or early study discontinuation
Title
Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures
Time Frame
Through study completion or early study discontinuation
Title
Incidence of anti-therapeutic antibodies
Time Frame
Through study completion or early study discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana McClintock, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
24224471
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.
Results Reference
derived
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A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
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