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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: lebrikizumab (MILR1444A)
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Genentech:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 210
Study Start Date: November 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: lebrikizumab (MILR1444A)
Subcutaneous repeating dose
Experimental: B Drug: lebrikizumab (MILR1444A)
Subcutaneous repeating dose
Experimental: C Drug: lebrikizumab (MILR1444A)
Subcutaneous repeating dose
Placebo Comparator: D Drug: placebo
Subcutaneous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971035

Sponsors and Collaborators
Genentech
Investigators
Study Director: Michelle Freemer, M.D. Genentech
  More Information

No publications provided

Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00971035     History of Changes
Other Study ID Numbers: ILR4660g
Study First Received: September 1, 2009
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
MILR1444A

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014