Back to resultsA Study of RO5036505 in Patients With Moderate to Severe Asthma
Primary Purpose
Asthma
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RO5036505
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
ACQ questionnaire, spirometry assessments, PEFR
Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
Secondary Outcome Measures
Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00967590
Brief Title
A Study of RO5036505 in Patients With Moderate to Severe Asthma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No patients dosed
Study Start Date
September 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RO5036505
Intervention Description
380mg iv infusion once weekly for 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
iv infusion once weekly for 8 weeks
Primary Outcome Measure Information:
Title
ACQ questionnaire, spirometry assessments, PEFR
Time Frame
every week up to day 95
Title
Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
Time Frame
assessed every week, laboratory parameters every 3-4 weeks, up to day 95
Secondary Outcome Measure Information:
Title
Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance
Time Frame
sampling every week up to day 95
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0561
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
City
Hereford
ZIP/Postal Code
HR1 2ER
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
12. IPD Sharing Statement
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A Study of RO5036505 in Patients With Moderate to Severe Asthma
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