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

May 4, 2010 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Drug: lebrikizumab (MILR1444A)
Repeating subcutaneous injection
PLACEBO_COMPARATOR: B
Drug: placebo
Repeating subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late asthmatic response (LAR)
Time Frame: Day 92
Day 92

Secondary Outcome Measures

Outcome Measure
Time Frame
Early asthmatic response (EAR)
Time Frame: Day 92
Day 92

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Edward Conner, M.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

October 27, 2008

First Posted (ESTIMATE)

October 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2010

Last Update Submitted That Met QC Criteria

May 4, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILR4544g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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