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A Study of RO4989991 in Patients With Allergic Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01152619
First Posted: June 29, 2010
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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: Placebo Drug: RO4989991 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Assessment of pharmacokinetics [ Time Frame: 24 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01152619     History of Changes
Other Study ID Numbers: PP22831
First Submitted: June 28, 2010
First Posted: June 29, 2010
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases