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
概览
- 阶段
- 3 期
- 干预措施
- Omalizumab
- 疾病 / 适应症
- Seasonal Allergic Rhinitis
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 337
- 试验地点
- 22
- 主要终点
- Mean Nasal Symptom Score
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Omalizumab
Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks
干预措施: Omalizumab
Placebo
Eligible patients randomized to this arm received placebo subcutaneously for 12 weeks
干预措施: Placebo
结局指标
主要结局
Mean Nasal Symptom Score
时间窗: Severe symptom period (from 23Feb2018 to 24March2018)
Nasal symptoms (sneezing, rhinorrhea and nasal congestion) were 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) consisted of score for severity of sneezing (0-4 point), rhinorrhea (0-4 point) and nasal congestion (0-4 point). Severe symptom period: The three weeks where the cumulative value of the mean daily nasal symptom score is the maximum. The three weeks must also meet one of the following criteria: 2) ≥ 70% of the period with concomitant use of fluticasone propionate is included in this three weeks. 2) ≥ 70% of this three weeks includes the period with concomitant use of fluticasone propionate. If not, severe symptom period was extended at a minimum to meet one of the criteria above. The severe symptom period will be defined as: the three weeks where the cumulative value of the mean daily nasal symptom score will be the maximum.
次要结局
- Mean Score for Severity of Itchy and Watery Eye(Severe symptom period (from 23Feb2018 to 24Mar2018))
- Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score(Severe symptom period (from 23Feb2018 to 24Mar2018))
- Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score(Severe symptom period (from 23Feb2018 to 24Mar2018))
- Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion(Severe symptom period (from 23Feb2018 to 24Mar2018))
- Number of Symptom Free Days(Severe symptom period (from 23Feb2018 to 24March2018))
- Completely Nasal Symptom Free Patients(Severe symptom period (from 23Feb2018 to 24Mar2018))
- Rescue Medication Score(Severe symptom period (from 23Feb2018 to 24Mar2018))
- Rescue Medication Free Days(Severe symptom period (from 23Feb2018 to 24Mar2018))
- Serum Trough Omalizumab Concentration(Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose)
- Mean Score for Impairment of Daily Activities(Severe symptom period (from 23Feb2018 to 24Mar2018))
- Number of Rescue Medication Used(Severe symptom period (from 23Feb2018 to 24Mar2018))
- Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score(Evaluation Visit, one visit during severe symptom period (23-Feb-2018 to 24-Mar-2018) for each patient)
- Free IgE and Total IgE(Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose)
- Number of Participants With Anti-omalizumab Antibodes(Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch)