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

NCT00983658 | Completed Phase 2

• 1 other identifier: OXF4696g
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma

Keywords

Anti-OX40L; Mild Allergic Asthma; Allergies; Allergic Asthma; Adult Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

huMAb OX40L

EXPERIMENTAL

Drug: huMAb OX40L

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

huMAb OX40L DRUG

Intravenous repeating dose

huMAb OX40L

placebo DRUG

Intravenous repeating dose

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (1)

• 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.

  PMID: 24224471 DERIVED

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Dana McClintock, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 24, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 2, 2016

Record last verified: 2013-08