A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.

Official Title
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A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)

Conditions
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Asthma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight ≥ 50 kg and ≤ 150 kg at Visit 1 Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality Stable asthma Exclusion Criteria: Asthma exacerbation during screening Known malignancy Known immunodeficiency Pre-existing lung disease other than asthma Uncontrolled clinically significant medical disease Current smoker History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator Prior allergic reaction to a monoclonal antibody Patients (men and women) of reproductive potential who are not willing to use contraception Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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>* Subcutaneous repeating dose<br>|
| Experimental: B<br> | Drug: lebrikizumab (MILR1444A)<br>* Subcutaneous repeating dose<br>|
| Experimental: C<br> | Drug: lebrikizumab (MILR1444A)<br>* Subcutaneous repeating dose<br>|
| Placebo Comparator: D<br> | Drug: placebo<br>* Subcutaneous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in forced expiratory volume in 1 second (FEV1) |  | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pre-bronchodilator FEV1 |  | Baseline to Week 24 | 
| Change in quality of life and symptom scores |  | Baseline to Week 12 | 
| Change in peak flow |  | Baseline to Week 1 | 
| Rate of asthma exacerbations |  | During the 24-week treatment period | 
| Change in rescue medication use |  | From baseline to Week 1 | 
| Frequency and severity of adverse events |  | From the first study-specific procedure through the last observation visit | 
| Incidence of human anti-therapeutic antibodies (ATA) |  | Baseline to Week 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MILR1444A