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

Allergic Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781443
• Other study ID #: ILR4544g
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2008
• Last updated: May 4, 2010
• Start date: December 2008

Study information

• Verified date: May 2010
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Meet criteria for the diagnosis of allergic asthma

• Diagnosis of asthma = 6 months

• Currently treated with only intermittent short-acting inhaled ß-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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Obstruction
• Allergic Asthma
• Asthma

Intervention

Drug:
• lebrikizumab (MILR1444A)
Repeating subcutaneous injection
• placebo
Repeating subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late asthmatic response (LAR)		Day 92	No
Secondary	Early asthmatic response (EAR)		Day 92	No