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

Asthma Clinical Trial

— MOLLY  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971035
• Other study ID #: ILR4660g
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2009
• Last updated: November 25, 2016
• Start date: November 2009
• Est. completion date: February 2011

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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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
• lebrikizumab (MILR1444A)
Subcutaneous repeating dose
• 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)		Baseline to Week 12	No
Secondary	Change in pre-bronchodilator FEV1		Baseline to Week 24	No
Secondary	Change in quality of life and symptom scores		Baseline to Week 12	No
Secondary	Change in peak flow		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		From the first study-specific procedure through the last observation visit	No
Secondary	Incidence of human anti-therapeutic antibodies (ATA)		Baseline to Week 32	No