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

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:

MedlinePlus related topics: Asthma Choking

U.S. FDA Resources

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

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 May 16, 2013