A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids (MILLY)

Genentech

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: placebo; Drug: lebrikizumab (MILR1444A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00930163

ILR4646g

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).

Enrollment: 218 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body weight 40 kg--150 kg
• Chest radiograph with no evidence of clinically significant abnormality
• Uncontrolled 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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218 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: lebrikizumab (MILR1444A)

2

Placebo Comparator group

Treatment:

Drug: placebo