A Study of RO4989991 in Patients With Allergic Rhinitis

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152619
• Other study ID #: PP22831
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2010
• Last updated: November 1, 2016
• Start date: July 2010
• Est. completion date: February 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Placebo
Subcutaneous repeated dose
• RO4989991
Subcutaneous repeated dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the safety and tolerability of RO4989991		24 weeks	No
Secondary	Assessment of pharmacokinetics		24 weeks	No