Trial record 4 of 12 for:    Ox40

A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

This study has been completed.
Information provided by (Responsible Party):
Genentech Identifier:
First received: September 21, 2009
Last updated: August 16, 2013
Last verified: August 2013

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
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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00983658

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

No publications provided by Genentech

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Genentech Identifier: NCT00983658     History of Changes
Other Study ID Numbers: OXF4696g
Study First Received: September 21, 2009
Last Updated: August 16, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Genentech:
Mild Allergic Asthma
Allergic Asthma
Adult Asthma

Additional relevant MeSH terms:
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on April 17, 2014