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

Status

Completed

Conditions

Intervention / Treatment

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

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.

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