NCT03369704

Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients

A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Adult and Adolescent Patients With Inadequately Controlled Severe Japanese Cedar Pollinosis Despite the Current Recommended Therapies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to demonstrate the efficacy and safety of omalizumab compared with placebo, on top of SoC (anti-histamine and nasal corticosteroid) in adult and adolescent patients with severe Japanese cedar pollinosis, whose symptoms were inadequately controlled despite the current recommended therapies (nasal corticosteroids plus one or more medications out of anti-histamine, leukotriene receptor antagonist, or prostaglandin D2/thromboxane A2 receptor antagonist) in the previous 2 Japanese cedar pollen seasons.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Omalizumab	Omalizumab were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.
DRUG	Placebo	Placebo were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.

Timeline

• Start date: 2017-12-15
• Primary completion: 2018-05-11
• Completion: 2018-10-20
• First posted: 2017-12-12
• Last updated: 2026-01-12
• Results posted: 2019-11-04

Locations

22 sites across 1 country: Japan