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A Study of RO4989991 in Patients With Allergic Rhinitis

NCT ID: NCT01152619

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

RO4989991

Intervention Type DRUG

Subcutaneous repeated dose

2

Group Type EXPERIMENTAL

RO4989991

Intervention Type DRUG

Subcutaneous repeated dose

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous repeated dose

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous repeated dose

Interventions

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Placebo

Subcutaneous repeated dose

Intervention Type DRUG

RO4989991

Subcutaneous repeated dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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South Miami, Florida, United States

Site Status

Normal, Illinois, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Spartanburg, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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PP22831

Identifier Type: -

Identifier Source: org_study_id