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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00781443
First Posted: October 29, 2008
Last Update Posted: May 6, 2010
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.
Information provided by:
Genentech, Inc.
  Purpose
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 Intervention Phase
Allergic Asthma Drug: lebrikizumab (MILR1444A) Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

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

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

Enrollment: 29
Study Start Date: December 2008
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: lebrikizumab (MILR1444A)
Repeating subcutaneous injection
Placebo Comparator: B Drug: placebo
Repeating subcutaneous injection

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00781443


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Edward Conner, M.D. Genentech, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00781443     History of Changes
Other Study ID Numbers: ILR4544g
First Submitted: October 27, 2008
First Posted: October 29, 2008
Last Update Posted: May 6, 2010
Last Verified: May 2010

Keywords provided by Genentech, Inc.:
Asthma

Additional relevant MeSH terms:
Asthma
Airway Obstruction
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Insufficiency
Respiration Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs