Back to resultsA Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Primary Purpose
Allergic Asthma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
lebrikizumab (MILR1444A)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Asthma focused on measuring Asthma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Late asthmatic response (LAR)
Secondary Outcome Measures
Early asthmatic response (EAR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00781443
Brief Title
A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
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 Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
lebrikizumab (MILR1444A)
Intervention Description
Repeating subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Repeating subcutaneous injection
Primary Outcome Measure Information:
Title
Late asthmatic response (LAR)
Time Frame
Day 92
Secondary Outcome Measure Information:
Title
Early asthmatic response (EAR)
Time Frame
Day 92
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Conner, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
24131304
Citation
Scheerens H, Arron JR, Zheng Y, Putnam WS, Erickson RW, Choy DF, Harris JM, Lee J, Jarjour NN, Matthews JG. The effects of lebrikizumab in patients with mild asthma following whole lung allergen challenge. Clin Exp Allergy. 2014 Jan;44(1):38-46. doi: 10.1111/cea.12220.
Results Reference
derived
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A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
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