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

This study has been completed.

Sponsor:

Information provided by:

Genentech

ClinicalTrials.gov Identifier:

NCT00971035

First received: September 1, 2009

Last updated: June 30, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2009

Last Updated Date

June 30, 2011

Start Date ^ICMJE

November 2009

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00971035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in pre-bronchodilator FEV1 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Change in quality of life and symptom scores [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Change in peak flow [ Time Frame: Baseline to Week 1 ] [ Designated as safety issue: No ]
Rate of asthma exacerbations [ Time Frame: During the 24-week treatment period ] [ Designated as safety issue: No ]
Change in rescue medication use [ Time Frame: From baseline to Week 1 ] [ Designated as safety issue: No ]
Frequency and severity of adverse events [ Time Frame: From the first study-specific procedure through the last observation visit ] [ Designated as safety issue: No ]
Incidence of human anti-therapeutic antibodies (ATA) [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A
Intervention: Drug: lebrikizumab (MILR1444A)
Experimental: B
Intervention: Drug: lebrikizumab (MILR1444A)
Experimental: C
Intervention: Drug: lebrikizumab (MILR1444A)
Placebo Comparator: D
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

210

Completion Date

February 2011

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00971035

Other Study ID Numbers ^ICMJE

ILR4660g

Has Data Monitoring Committee

Not Provided

Responsible Party

Disclosures Group, Genentech, Inc.

Study Sponsor ^ICMJE

Genentech

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Michelle Freemer, M.D.

Genentech

Information Provided By

Genentech

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top