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

NCT ID: NCT00983658

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

huMAb OX40L

Group Type: EXPERIMENTAL

huMAb OX40L

Intervention Type: DRUG

Intravenous repeating dose

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Intravenous repeating dose

Interventions

huMAb OX40L

Intravenous repeating dose

Intervention Type: DRUG

placebo

Intravenous repeating dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana McClintock, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

References

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.

Reference Type: DERIVED

PMID: 24224471 (View on PubMed)

Other Identifiers

OXF4696g

Identifier Type: -

Identifier Source: org_study_id