A Study of RO4989991 in Patients With Allergic Rhinitis

Roche

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: RO4989991; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01152619

PP22831

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: RO4989991

2

Experimental group

Treatment:

Drug: RO4989991

3

Placebo Comparator group

Treatment:

Drug: Placebo

4

Placebo Comparator group

Treatment:

Drug: Placebo