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A Study of RO5036505 in Patients With Moderate to Severe Asthma

NCT ID: NCT00967590

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

RO5036505

Intervention Type DRUG

380mg iv infusion once weekly for 8 weeks

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

iv infusion once weekly for 8 weeks

Interventions

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RO5036505

380mg iv infusion once weekly for 8 weeks

Intervention Type DRUG

placebo

iv infusion once weekly for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Hoffmann-La Roche

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Little Rock, Arkansas, United States

Site Status

San Diego, California, United States

Site Status

Denver, Colorado, United States

Site Status

Normal, Illinois, United States

Site Status

River Forest, Illinois, United States

Site Status

Boston, Massachusetts, United States

Site Status

St Louis, Missouri, United States

Site Status

Omaha, Nebraska, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Cleveland, Ohio, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Spartanburg, South Carolina, United States

Site Status

Galveston, Texas, United States

Site Status

Madison, Wisconsin, United States

Site Status

Hereford, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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2009-013379-23

Identifier Type: -

Identifier Source: secondary_id

PP22666

Identifier Type: -

Identifier Source: org_study_id

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