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Completed

NCT Number: NCT00971035

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lebrikizumab (MILR1444A)

Drug

Subcutaneous repeating dose

Placebo

Drug

Subcutaneous repeating dose

Primary outcomes

  1. Change in forced expiratory volume in 1 second (FEV1)

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Change in pre-bronchodilator FEV1

    Time frame: Baseline to Week 24

  2. Change in quality of life and symptom scores

    Time frame: Baseline to Week 12

  3. Change in peak flow

    Time frame: Baseline to Week 1

  4. Rate of asthma exacerbations

    Time frame: During the 24-week treatment period

  5. Change in rescue medication use

    Time frame: From baseline to Week 1

  6. Frequency and severity of adverse events

    Time frame: From the first study-specific procedure through the last observation visit

  7. Incidence of human anti-therapeutic antibodies (ATA)

    Time frame: Baseline to Week 32

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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)

Acronym: MOLLY

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 3, 2009
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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