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

NCT00781443 | Completed Phase 2

• 1 other identifier: ILR4544g
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Late asthmatic response (LAR)

  Day 92

Secondary Outcomes (1)

• Early asthmatic response (EAR)

  Day 92

Study Arms (2)

A

EXPERIMENTAL

Drug: lebrikizumab (MILR1444A)

B

PLACEBO COMPARATOR

Drug: placebo

Interventions

lebrikizumab (MILR1444A) DRUG

Repeating subcutaneous injection

A

placebo DRUG

Repeating subcutaneous injection

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (1)

• 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.

  PMID: 24131304 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Edward Conner, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 29, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Last Updated: May 6, 2010

Record last verified: 2010-05