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

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: Asthma
• Intervention / Treatment: Drug: placebo; Drug: huMAb OX40L

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; Intravenous repeating dose
Experimental: huMAb OX40L	Drug: 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	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	Approximately Day 56 prior to third dose
Change in methacholine challenge response relative to the pre-allergen challenge PC20	24 hours after each allergen challenge
Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo	Between 0 and 2 hours after each allergen challenge
Incidence and nature of treatment-emergent adverse events	Through study completion or early study discontinuation
Incidence and nature of infusion reactions	Through study completion or early study discontinuation
Incidence of infectious complications	Through study completion or early study discontinuation
Incidence, nature, relatedness, and severity of adverse events	Through study completion or early study discontinuation
Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures	Through study completion or early study discontinuation
Incidence of anti-therapeutic antibodies	Through study completion or early study discontinuation

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Dana McClintock, M.D., Genentech, Inc.

Publications and helpful links

General Publications

• Gauvreau GM, Boulet LP, Cockcroft DW, FitzGerald JM, Mayers I, Carlsten C, Laviolette M, Killian KJ, Davis BE, Larche M, Kipling C, Dua B, Mosesova S, Putnam W, Zheng Y, Scheerens H, McClintock D, Matthews JG, O'Byrne PM. OX40L blockade and allergen-induced airway responses in subjects with mild asthma. Clin Exp Allergy. 2014 Jan;44(1):29-37. doi: 10.1111/cea.12235.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): January 5, 2011

Study Registration Dates

• First Submitted: September 21, 2009
• First Submitted That Met QC Criteria: September 22, 2009
• First Posted (Estimated): September 24, 2009

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Allergic Asthma; Allergies; Adult Asthma; Anti-OX40L; Mild Allergic Asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Asthma; Hypersensitivity
• Other Study ID Numbers: OXF4696g