Trial record 4 of 12 for:    Ox40

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00983658
First received: September 21, 2009
Last updated: August 16, 2013
Last verified: August 2013

September 21, 2009
August 16, 2013
September 2009
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00983658 on ClinicalTrials.gov Archive Site
  • LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo [ Time Frame: Approximately Day 56 prior to third dose ] [ Designated as safety issue: No ]
  • Change in methacholine challenge response relative to the pre-allergen challenge PC20 [ Time Frame: 24 hours after each allergen challenge ] [ Designated as safety issue: No ]
  • Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo [ Time Frame: Between 0 and 2 hours after each allergen challenge ] [ Designated as safety issue: No ]
  • Incidence and nature of treatment-emergent adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence and nature of infusion reactions [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence of infectious complications [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature, relatedness, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo [ Time Frame: Approximately Day 56 prior to third dose ] [ Designated as safety issue: No ]
  • Change in methacholine challenge response relative to the pre-allergen challenge PC20 [ Time Frame: 24 hours after each allergen challenge ] [ Designated as safety issue: No ]
  • Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo [ Time Frame: Between 0 and 2 hours after each allergen challenge ] [ Designated as safety issue: No ]
  • Incidence and nature of treatment-emergent adverse events [ Time Frame: Through study completion (Day 253) or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence and nature of infusion reactions [ Time Frame: Through study completion (Day 253) or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence of infectious complications [ Time Frame: Through study completion (Day 253) or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature, relatedness, and severity of adverse events [ Time Frame: Through study completion (Day 253) or early study discontinuation ] [ Designated as safety issue: No ]
  • Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures [ Time Frame: Through study completion (Day 253) or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies [ Time Frame: Through study completion (Day 253) or early study discontinuation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: huMAb OX40L
    Intravenous repeating dose
  • Drug: placebo
    Intravenous repeating dose
  • Experimental: 1
    Intervention: Drug: huMAb OX40L
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Gauvreau GM, Boulet LP, Cockcroft DW, FitzGerald JM, Mayers I, Carlsten C, Laviolette M, Killian KJ, Davis BE, Larché 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
January 2011
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00983658
OXF4696g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Dana McClintock, M.D. Genentech
Genentech
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP