A Study of RO5036505 in Patients With Moderate to Severe Asthma

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00967590

Run by

Hoffmann-La Roche

People needed

0

Starts

2009-09-01

Expected to finish

2010-08-01

Last updated by the study team

2016-08-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Normal, Illinois, United States
• Study site — River Forest, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Galveston, Texas, United States
• Study site — Madison, Wisconsin, United States
• Study site — Hereford, United Kingdom
• Study site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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