A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Pat... | NCT00971035

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

NCT00971035

Sponsor

Genentech, Inc.

Status

Completed

Last Update Posted

Nov 29, 2016Estimated

Enrollment

210Actual

Phase

Phase 2

Conditions

Asthma

Interventions

lebrikizumab (MILR1444A)
lebrikizumab (MILR1444A)
lebrikizumab (MILR1444A)
placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Sep 1, 2009

First Submission Date that Met QC Criteria

Sep 2, 2009

First Posted Date

Sep 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 30, 2011

Certification/Extension First Submitted that Passed QC Review

Jun 30, 2011

Certification/Extension First Posted Date

Jul 13, 2011Estimated

Last Update Submitted Date

Nov 25, 2016

Last Update Posted Date

Nov 29, 2016Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lebrikizumab (MILR1444A)	Drug	Subcutaneous repeating dose	A
lebrikizumab (MILR1444A)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michelle Freemer, M.D.	Genentech, Inc.	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C561806	lebrikizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided