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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Allergic Asthma

Intervention / Treatment
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* Drug: lebrikizumab (MILR1444A)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: lebrikizumab (MILR1444A)<br>* Repeating subcutaneous injection<br>|
| Placebo Comparator: B<br> | Drug: placebo<br>* Repeating subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late asthmatic response (LAR) |  | Day 92 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early asthmatic response (EAR) |  | Day 92 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma