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

Conditions

• Seasonal Allergic Rhinitis

Eligibility Criteria

Sex

ALL

Age

12 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  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.
• Placebo — DRUG
  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.

Study Details

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.

Key Dates

Start date

Dec 15, 2017

Status verified

Dec 2025

Primary completion

May 11, 2018

Completion

Oct 20, 2018

Study Design

Enrollment

337 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Omalizumab
  Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks
• Placebo Comparator: Placebo
  Eligible patients randomized to this arm received placebo subcutaneously for 12 weeks

Primary Outcome Measure

Mean Nasal Symptom Score [ Time Frame: Severe symptom period (from 23Feb2018 to 24March2018) ]