Clinical trial NCT03369704: Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: cryptomeria, omalizumab, seasonal allergic rhinitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 337
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 μg/day fluticasone propionate or an equivalent for aged ≥ 16 to \<75 years, \> 200 μg/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.

Primary outcomes:
measure: Mean Nasal Symptom Score
timeFrame: Severe symptom period (from 23Feb2018 to 24March2018)
Secondary outcomes:
measure: Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score
timeFrame: Severe symptom period (from 23Feb2018 to 24Mar2018)
measure: Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score
timeFrame: Severe symptom period (from 23Feb2018 to 24Mar2018)
measure: Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion
timeFrame: Severe symptom period (from 23Feb2018 to 24Mar2018)
measure: Mean Score for Severity of Itchy and Watery Eye
timeFrame: Severe symptom period (from 23Feb2018 to 24Mar2018)
measure: Mean Score for Impairment of Daily Activities
timeFrame: Severe symptom period (from 23Feb2018 to 24Mar2018)
measure: Number of Symptom Free Days
timeFrame: Severe symptom period (from 23Feb2018 to 24March2018)
measure: Completely Nasal Symptom Free Patients
timeFrame: Severe symptom period (from 23Feb2018 to 24Mar2018)
measure: Rescue Medication Score
timeFrame: Severe symptom period (from 23Feb2018 to 24Mar2018)
measure: Rescue Medication Free Days
timeFrame: Severe symptom period (from 23Feb2018 to 24Mar2018)
measure: Number of Rescue Medication Used
timeFrame: Severe symptom period (from 23Feb2018 to 24Mar2018)
measure: Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score
timeFrame: Evaluation Visit, one visit during severe symptom period (23-Feb-2018 to 24-Mar-2018) for each patient
measure: Number of Participants With Anti-omalizumab Antibodes
timeFrame: Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch
measure: Serum Trough Omalizumab Concentration
timeFrame: Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose
measure: Free IgE and Total IgE
timeFrame: Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose
Other outcomes:
Locations:
city: Chiba-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Ichikawa-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Kashiwa-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsudo-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsudo-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Urayasu city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Koshigaya-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Arakawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: