A Study of RO4989991 in Patients With Allergic Rhinitis

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: RO4989991; Drug: Placebo

• Registration Number: NCT01152619
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Study Start: 2010-07
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RO4989991	-
3	Placebo	-
4	Placebo	-
2	RO4989991	-

Primary Outcome Measures

Name	Time	Method
Assessment of the safety and tolerability of RO4989991	24 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of pharmacokinetics	24 weeks