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A Study of RO4989991 in Patients With Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT01152619
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

June 28, 2010
June 29, 2010
November 2, 2016
July 2010
February 2011   (Final data collection date for primary outcome measure)
Assessment of the safety and tolerability of RO4989991 [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT01152619 on ClinicalTrials.gov Archive Site
Assessment of pharmacokinetics [ Time Frame: 24 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ClinicalTrials.gov 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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