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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: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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
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, Missouri
St Louis, Missouri, United States, 63141
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: May 23, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013