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A Study of RO5036505 in Patients With Moderate to Severe Asthma

This study has been withdrawn prior to enrollment.
(No patients dosed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00967590
First Posted: August 28, 2009
Last Update Posted: August 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hoffmann-La Roche
August 21, 2009
August 28, 2009
August 24, 2016
September 2009
Not Provided
  • ACQ questionnaire, spirometry assessments, PEFR [ Time Frame: 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 ]
Same as current
Complete list of historical versions of study NCT00967590 on ClinicalTrials.gov Archive Site
Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance [ Time Frame: sampling every week up to day 95 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Asthma
  • Drug: RO5036505
    380mg iv infusion once weekly for 8 weeks
  • Drug: placebo
    iv infusion once weekly for 8 weeks
  • Experimental: 1
    Intervention: Drug: RO5036505
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2010
Not Provided

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
 
NCT00967590
PP22666
2009-013379-23
Not Provided
Not Provided
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP