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:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00781443
First received: October 27, 2008
Last updated: May 4, 2010
Last verified: May 2010
  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 Blind (Subject, Caregiver)
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:

Primary Outcome Measures:
  • Late asthmatic response (LAR) [ Time Frame: Day 92 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Early asthmatic response (EAR) [ Time Frame: Day 92 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781443

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

No publications provided by Genentech

Additional 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
Study First Received: October 27, 2008
Last Updated: May 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Asthma

Additional relevant MeSH terms:
Airway Obstruction
Asthma
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014