A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
This study has been completed.
Sponsor:
Genentech
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00983658
First received: September 21, 2009
Last updated: April 15, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: huMAb OX40L Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo [ Time Frame: Approximately Day 56 prior to third dose ] [ Designated as safety issue: No ]
- Change in methacholine challenge response relative to the pre-allergen challenge PC20 [ Time Frame: 24 hours after each allergen challenge ] [ Designated as safety issue: No ]
- Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo [ Time Frame: Between 0 and 2 hours after each allergen challenge ] [ Designated as safety issue: No ]
- Incidence and nature of treatment-emergent adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- Incidence and nature of infusion reactions [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- Incidence of infectious complications [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- Incidence, nature, relatedness, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- Incidence of anti-therapeutic antibodies [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
| Enrollment: | 29 |
| Study Start Date: | September 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: huMAb OX40L
Intravenous repeating dose
|
| Placebo Comparator: 2 |
Drug: placebo
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Clinical Trials Posting Group, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00983658 History of Changes |
| Other Study ID Numbers: | OXF4696g |
| Study First Received: | September 21, 2009 |
| Last Updated: | April 15, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Genentech:
|
Anti-OX40L Mild Allergic Asthma Allergies Allergic Asthma Adult Asthma |
Additional relevant MeSH terms:
|
Airway Obstruction Asthma Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013