A Study of RO4989991 in Patients With Allergic Rhinitis

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01152619

Enrollment

Registered

2010-06-29

Start date

2010-07-31

Completion date

2011-02-28

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGPlacebo

Subcutaneous repeated dose

DRUGRO4989991

Subcutaneous repeated dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessment of the safety and tolerability of RO4989991	24 weeks

Secondary

Measure	Time frame
Assessment of pharmacokinetics	24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026