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

Asthma Clinical Trial

— MILLY  

Official title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930163
• Other study ID #: ILR4646g
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2009
• Last updated: November 25, 2016
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• lebrikizumab (MILR1444A)
Subcutaneous repeating dose
• placebo
Subcutaneous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in forced expiratory volume in 1 second (FEV1)		From baseline to Week 12	No
Secondary	Change in pre-bronchodilator FEV1		From baseline to Week 24	No
Secondary	Change in quality of life and symptom scores		From baseline to Week 12	No
Secondary	Change in peak flow		From baseline to Week 1	No
Secondary	Rate of asthma exacerbations		During the 24 week treatment period	No
Secondary	Change in rescue medication use		From baseline to Week 1	No
Secondary	Frequency and severity of adverse events		Through study completion or early study discontinuation	No
Secondary	Incidence of human anti-therapeutic antibodies (ATA)		At the end of the follow-up period	No