Study Stopped
No patients dosed
A Study of RO5036505 in Patients With Moderate to Severe Asthma
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
2 other identifiers
interventional
N/A
2 countries
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2009
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2009
CompletedFirst Posted
Study publicly available on registry
August 28, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedAugust 24, 2016
August 1, 2016
August 21, 2009
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
ACQ questionnaire, spirometry assessments, PEFR
every week up to day 95
Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
assessed every week, laboratory parameters every 3-4 weeks, up to day 95
Secondary Outcomes (1)
Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance
sampling every week up to day 95
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Little Rock, Arkansas, 72202, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Denver, Colorado, 80206, United States
Unknown Facility
Normal, Illinois, 61761, United States
Unknown Facility
River Forest, Illinois, 60305, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
St Louis, Missouri, 63130, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Spartanburg, South Carolina, 29303, United States
Unknown Facility
Galveston, Texas, 77555-0561, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Hereford, HR1 2ER, United Kingdom
Unknown Facility
Manchester, M23 9QZ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 21, 2009
First Posted
August 28, 2009
Study Start
September 1, 2009
Study Completion
August 1, 2010
Last Updated
August 24, 2016
Record last verified: 2016-08