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

NCT ID: NCT00781443

Last Updated: 2010-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31

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.

Conditions

Allergic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Group Type: EXPERIMENTAL

lebrikizumab (MILR1444A)

Intervention Type: DRUG

Repeating subcutaneous injection

B

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Repeating subcutaneous injection

Interventions

lebrikizumab (MILR1444A)

Repeating subcutaneous injection

Intervention Type: DRUG

placebo

Repeating subcutaneous injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Genentech, Inc.

Principal Investigators

Edward Conner, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

References

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.

Reference Type: DERIVED

PMID: 24131304 (View on PubMed)

Other Identifiers

ILR4544g

Identifier Type: -

Identifier Source: org_study_id