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

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis

• Registration Number: JPRN-jRCT2080223757
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-19
• Study Completion: 2019-03-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

* A clinical history of Japanese cedar pollinosis defined by the following:
* Took nasal corticosteroid plus one or more medications out of antihistamine (second generation), leukotriene receptor antagonist, or prostaglandin D2 thromboxane A2 receptor antagonist in Japanese cedar pollen seasons in 2016 and 2017.
* Had inadequately controlled symptoms of Japanese cedar pollinosis lasting at least one week in the Japanese cedar pollen season in 2017 despite the nasal corticosteroid plus one or more medications out of anti-histamine (second generation), leukotriene receptor antagonist, or prostaglandin D2/thromboxane A2 receptor antagonist (regardless of having perennial allergic rhinitis or not)
* Serum cedar pollen-specific Immunoglobulin E (IgE) levels of >= score of 3 by CAP/RAST-FEIA, ImmunoCAP or MAST at the screening epoch.
* Developing a symptom of Japanese cedar pollinosis during the period from first observational day in cedar pollen in Kanto area to initial drug administration (Visit 101), as defined by the following:
* Having any nasal or ocular symptom (>= score of 1 in sneezing, rhinorrhea, nasal congestion, itchy eye or watery eye) in at least 2 days or
* Having both any nasal symptom (>= score of 1 in sneezing, rhinorrhea, nasal congestion) and any eye symptom (>= score of 1 in itchy eye or watery eye) in at least one day, which is confirmed by patient e-diary (unless a symptom is clearly consider to take place due to other than Japanese cedar pollinosis/allergic rhinitis (e.g., upper respiratory tract infection, or common cold)).
* Body weight and serum total IgE level at screen epoch within the dosing table range; body weight of >= 20 to =< 150 kg and serum total IgE levels of >= 30 to =< 1500 IU/mL at a maximum.

Exclusion Criteria

* With an active rhinitis other than allergic rhinitis (e.g acute or chronic rhinitis, idiopathic rhinitis).
* With an active nose disease other than allergic rhinitis (e.g., acute or chronic rhinosinusitis or deflected septum) which is expected to affect the evaluation of efficacy of the study drug judged by the investigator.
* With elevated serum IgE levels for reasons other than allergy (e.g., parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or clinical allergic bronchopulmonary aspergillosis).
* With a severe asthma treated with high dose inhaled corticosteroid (>= 800 microgram/day fluticasone propionate or an equivalent for aged >= 16 to <75 years, > 200 microgram/day for aged >= 12 to <16 years).
* Who are receiving operative treatment for allergic rhinitis (e.g., electrocoagulation, laser surgery, 80% trichloroacetic acid chemo-surgery, inferior turbinectomy or posterior nasal neurectomy) within 1 years prior to the screening epoch.

Other protocol defined inclusion/exclusion may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Mean nasal symptom score [ Time Frame: In the severe symptom period, which is defined as the three weeks where the cumulative value of the mean daily nasal symptom score will be the maximum. ]<br>Nasal symptoms (sneezing, rhinorrhea and nasal congestion) will be recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Nasal symptom score (0-12 point) consists of score for severity of sneezing (0-4 point), rhinorrhea (0-4 point) and nasal congestion (0-4 point).