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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:
ClinicalTrials.gov Identifier:
NCT00983658
First Posted: September 24, 2009
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  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 (Participant, 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, Inc.:

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 ]

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 ]
  • Change in methacholine challenge response relative to the pre-allergen challenge PC20 [ Time Frame: 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 ]
  • Incidence and nature of treatment-emergent adverse events [ Time Frame: Through study completion or early study discontinuation ]
  • Incidence and nature of infusion reactions [ Time Frame: Through study completion or early study discontinuation ]
  • Incidence of infectious complications [ Time Frame: Through study completion or early study discontinuation ]
  • Incidence, nature, relatedness, and severity of adverse events [ Time Frame: 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 ]
  • Incidence of anti-therapeutic antibodies [ Time Frame: Through study completion or early study discontinuation ]

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: huMAb OX40L Drug: huMAb OX40L
Intravenous repeating dose
Placebo Comparator: Placebo Drug: placebo
Intravenous repeating dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983658


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Dana McClintock, M.D. Genentech, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00983658     History of Changes
Other Study ID Numbers: OXF4696g
First Submitted: September 21, 2009
First Posted: September 24, 2009
Last Update Posted: August 2, 2016
Last Verified: August 2013

Keywords provided by Genentech, Inc.:
Anti-OX40L
Mild Allergic Asthma
Allergies
Allergic Asthma
Adult Asthma

Additional relevant MeSH terms:
Asthma
Airway Obstruction
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Insufficiency
Respiration Disorders