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A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00781443
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : May 6, 2010
Information provided by:
Genentech, Inc.

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The study will randomize approximately 24 patients at five study centers. In the event of patient discontinuation from the study, additional patients may be enrolled at the discretion of the Sponsor.

Condition or disease Intervention/treatment Phase
Allergic Asthma Drug: lebrikizumab (MILR1444A) Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Study Start Date : December 2008
Actual Primary Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Choking

Arm Intervention/treatment
Experimental: A Drug: lebrikizumab (MILR1444A)
Repeating subcutaneous injection

Placebo Comparator: B Drug: placebo
Repeating subcutaneous injection

Primary Outcome Measures :
  1. Late asthmatic response (LAR) [ Time Frame: Day 92 ]

Secondary Outcome Measures :
  1. Early asthmatic response (EAR) [ Time Frame: Day 92 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meet criteria for the diagnosis of allergic asthma
  • Diagnosis of asthma ≥ 6 months
  • Currently treated with only intermittent short-acting inhaled β-adrenergic agonists
  • Body weight between 40-120 kg
  • Normal chest X-ray within 2 years of screening

Exclusion Criteria:

  • Require daily controller medication for asthma
  • History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin)
  • Documented medical history of anaphylaxis
  • Immunotherapy currently or within the past 3 months prior to screening
  • Lung disease other than mild allergic asthma
  • Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
  • Pregnant or lactating
  • Significant concurrent medical illness other than asthma
  • Clinically significant abnormality on ECG at the screening visit
  • Smoked in the previous 6 months or have a history of smoking more than 10 pack-years
  • History of helminthic infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00781443

Sponsors and Collaborators
Genentech, Inc.
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Study Director: Edward Conner, M.D. Genentech, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Clinical Trials Posting Group, Genentech, Inc. Identifier: NCT00781443    
Other Study ID Numbers: ILR4544g
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: May 6, 2010
Last Verified: May 2010
Keywords provided by Genentech, Inc.:
Additional relevant MeSH terms:
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Airway Obstruction
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Insufficiency
Respiration Disorders