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A Study of RO4989991 in Patients With Allergic Rhinitis

Primary Purpose

Asthma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

RO4989991

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Assessment of the safety and tolerability of RO4989991

Secondary Outcome Measures

Assessment of pharmacokinetics

Full Information

NCT ID

NCT01152619

First Posted

June 28, 2010

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01152619

Brief Title

A Study of RO4989991 in Patients With Allergic Rhinitis

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous repeated dose

Intervention Type

Drug

Intervention Name(s)

RO4989991

Intervention Description

Subcutaneous repeated dose

Primary Outcome Measure Information:

Title

Assessment of the safety and tolerability of RO4989991

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Assessment of pharmacokinetics

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

12. IPD Sharing Statement

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A Study of RO4989991 in Patients With Allergic Rhinitis

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