Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of RO4989991 in Patients With Allergic Rhinitis

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 28, 2010
Last updated: March 2, 2015
Last verified: March 2015

June 28, 2010
March 2, 2015
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 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 evaluate the safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis who are otherwise healthy. The anticipated time on study treatment is 2 weeks.

Not Provided
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Drug: Placebo
    Subcutaneous repeated dose
  • Drug: RO4989991
    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 Identifier (NCT Number) in Medline.
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
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2015

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