A Study of RO5036505 in Patients With Moderate to Severe Asthma

August 23, 2016 updated by: Hoffmann-La Roche

A Multi-center, Randomized, Double-Blind, Multiple-Dose, Placebo-controlled Asthma Control Study Evaluating the Efficacy, Safety, and Tolerability of RO5036505 in Subjects With Moderate-to-Severe Asthma

This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of RO5036505 in patients with inadequately controlled moderate to severe asthma. Patients will be randomized to receive either RO5036505 (380mg iv infusion once weekly) or placebo for 8 weeks. Patients will be on a standardized inhaled corticosteroid/long-acting beta-agonist regimen during study treatment. Target sample size is 50-100 individuals.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Hereford, United Kingdom, HR1 2ER
      • Manchester, United Kingdom, M23 9QZ
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
    • California
      • San Diego, California, United States, 92103
    • Colorado
      • Denver, Colorado, United States, 80206
    • Illinois
      • Normal, Illinois, United States, 61761
      • River Forest, Illinois, United States, 60305
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Missouri
      • Saint Louis, Missouri, United States, 63130
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
    • Texas
      • Galveston, Texas, United States, 77555-0561
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 18-70 years of age
  • moderate to severe asthma for >/=2 years
  • ACQ score >/= 1.5
  • ICS and LABA regimen at moderate to high dose
  • non-smokers

Exclusion Criteria:

  • oral corticosteroid use within 4 weeks prior to screening
  • current escalating immunotherapy
  • acute infection/antibiotic therapy within 4 weeks prior to screening, or chronic infection
  • pulmonary disease other than asthma
  • therapy with any approved monoclonal antibody or biologic agent within 12 months prior to screening
  • previous exposure to investigational monoclonal antibodies or biologics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: RO5036505
380mg iv infusion once weekly for 8 weeks
Placebo Comparator: 2
Drug: placebo
iv infusion once weekly for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACQ questionnaire, spirometry assessments, PEFR
Time Frame: every week up to day 95
every week up to day 95
Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
Time Frame: assessed every week, laboratory parameters every 3-4 weeks, up to day 95
assessed every week, laboratory parameters every 3-4 weeks, up to day 95

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance
Time Frame: sampling every week up to day 95
sampling every week up to day 95

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

August 21, 2009

First Submitted That Met QC Criteria

August 27, 2009

First Posted (Estimate)

August 28, 2009

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP22666
  • 2009-013379-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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