A Study of RO4989991 in Patients With Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01152619
First received: June 28, 2010
Last updated: August 4, 2014
Last verified: August 2014

June 28, 2010
August 4, 2014
July 2010
February 2011   (final data collection date for primary outcome measure)
Assessment of the safety and tolerability of RO4989991 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01152619 on ClinicalTrials.gov Archive Site
Assessment of pharmacokinetics [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of RO4989991 in Patients With Allergic Rhinitis
A Multi-center, Randomized, Observer-blind, Placebo-controlled Safety and Tolerability Study of Repeated Administration of Two Dose Levels of RO4989991 Administered Subcutaneously to Patients With Allergic Rhinitis

This multi-center, randomized, observer-blinded, placebo-controlled study will e valuate the safety and tolerability of subcutaneous doses of RO4989991 in patien ts with allergic rhinitis who are otherwise healthy. The anticipated time on stu dy treatment is 2 weeks.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: RO4989991
    Subcutaneous repeated dose
  • Drug: Placebo
    Subcutaneous repeated dose
  • Experimental: 1
    Intervention: Drug: RO4989991
  • Experimental: 2
    Intervention: Drug: RO4989991
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
  • Placebo Comparator: 4
    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.
 
Completed
24
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, 18-65 years of age, inclusively
  • A history of allergic rhinitis diagnosed by a physician, but otherwise healthy
  • A positive skin prick test to at least one standardized allergen at screening
  • A body mass index (BMI) between 18 and 32 kg/m2, inclusively

Exclusion Criteria:

  • History or presence of any respiratory disease or condition other than allergic rhinitis
  • Use of prescription medication or herbal remedies within 14 days of dosing the study drug
  • Use of over-the-counter (OTC) medications within 7 days of dosing the study drug
  • Acute infection (including viral infections) 6 weeks (8 weeks for respiratory infections) preceding dosing or any ongoing chronic infection
  • Positive test for human immunodeficiency virus (HIV) or hepatitis B or C
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01152619
PP22831
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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