- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00983658
A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
August 1, 2016 updated by: Genentech, Inc.
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
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 Overview
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Intravenous repeating dose
|
Experimental: huMAb OX40L
|
Intravenous repeating dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
16 weeks after the first dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo
Time Frame: Approximately Day 56 prior to third dose
|
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
|
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
|
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
|
Through study completion or early study discontinuation
|
Incidence and nature of infusion reactions
Time Frame: Through study completion or early study discontinuation
|
Through study completion or early study discontinuation
|
Incidence of infectious complications
Time Frame: Through study completion or early study discontinuation
|
Through study completion or early study discontinuation
|
Incidence, nature, relatedness, and severity of adverse events
Time Frame: Through study completion or early study discontinuation
|
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
|
Through study completion or early study discontinuation
|
Incidence of anti-therapeutic antibodies
Time Frame: Through study completion or early study discontinuation
|
Through study completion or early study discontinuation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dana McClintock, M.D., Genentech, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
September 21, 2009
First Submitted That Met QC Criteria
September 22, 2009
First Posted (Estimate)
September 24, 2009
Study Record Updates
Last Update Posted (Estimate)
August 2, 2016
Last Update Submitted That Met QC Criteria
August 1, 2016
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OXF4696g
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarRecruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States