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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983658
• Other study ID #: OXF4696g
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2009
• Last updated: August 1, 2016
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: August 2013
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ß2-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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Obstruction
• Asthma

Intervention

Drug:
• huMAb OX40L
Intravenous repeating dose
• placebo
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo		16 weeks after the first dose	No
Secondary	LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo		Approximately Day 56 prior to third dose	No
Secondary	Change in methacholine challenge response relative to the pre-allergen challenge PC20		24 hours after each allergen challenge	No
Secondary	Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo		Between 0 and 2 hours after each allergen challenge	No
Secondary	Incidence and nature of treatment-emergent adverse events		Through study completion or early study discontinuation	No
Secondary	Incidence and nature of infusion reactions		Through study completion or early study discontinuation	No
Secondary	Incidence of infectious complications		Through study completion or early study discontinuation	No
Secondary	Incidence, nature, relatedness, and severity of adverse events		Through study completion or early study discontinuation	No
Secondary	Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures		Through study completion or early study discontinuation	No
Secondary	Incidence of anti-therapeutic antibodies		Through study completion or early study discontinuation	No