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NCT Number: NCT01152619

A Study of RO4989991 in Patients With Allergic Rhinitis

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

South Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Subcutaneous repeated dose

RO4989991

Drug

Subcutaneous repeated dose

Primary outcomes

  1. Assessment of the safety and tolerability of RO4989991

    Time frame: 24 weeks

Secondary outcomes

  1. Assessment of pharmacokinetics

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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