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 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Placebo
Drug: RO4989991
Phase 1

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, Observer-blind, Placebo-controlled Safety and Tolerability Study of Repeated Administration of Two Dose Levels of RO4989991 Administered Subcutaneously to Patients With Allergic Rhinitis

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Assessment of the safety and tolerability of RO4989991 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of pharmacokinetics [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO4989991
Subcutaneous repeated dose
Experimental: 2 Drug: RO4989991
Subcutaneous repeated dose
Placebo Comparator: 3 Drug: Placebo
Subcutaneous repeated dose
Placebo Comparator: 4 Drug: Placebo
Subcutaneous repeated dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152619

Locations
United States, Florida
South Miami, Florida, United States, 33143
United States, Illinois
Normal, Illinois, United States, 61761
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, South Carolina
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01152619     History of Changes
Other Study ID Numbers: PP22831
Study First Received: June 28, 2010
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014