A Study of RO5036505 in Patients With Moderate to Severe Asthma

This study has been withdrawn prior to enrollment.
(No patients dosed)
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00967590
First received: August 21, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: RO5036505
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • ACQ questionnaire, spirometry assessments, PEFR [ Time Frame: every week up to day 95 ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters [ Time Frame: assessed every week, laboratory parameters every 3-4 weeks, up to day 95 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance [ Time Frame: sampling every week up to day 95 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: August 2010
Arms Assigned Interventions
Experimental: 1 Drug: RO5036505
380mg iv infusion once weekly for 8 weeks
Placebo Comparator: 2 Drug: placebo
iv infusion once weekly for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967590

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, California
San Diego, California, United States, 92103
United States, Colorado
Denver, Colorado, United States, 80206
United States, Illinois
Normal, Illinois, United States, 61761
River Forest, Illinois, United States, 60305
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Missouri
Saint Louis, Missouri, United States, 63130
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Ohio
Cincinnati, Ohio, United States, 45242
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
Galveston, Texas, United States, 77555-0561
United States, Wisconsin
Madison, Wisconsin, United States, 53792
United Kingdom
Hereford, United Kingdom, HR1 2ER
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00967590     History of Changes
Other Study ID Numbers: PP22666, 2009-013379-23
Study First Received: August 21, 2009
Last Updated: September 1, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014