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

NCT03369704 | Completed Phase 3 Results

• 1 other identifier: CIGE025F1301
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 22

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

cryptomeria, omalizumab, seasonal allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean Nasal Symptom Score

  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.

  Severe symptom period (from 23Feb2018 to 24March2018)

Secondary Outcomes (14)

• 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)

• Mean Score for Severity of Itchy and Watery Eye

  Severe symptom period (from 23Feb2018 to 24Mar2018)

• Mean Score for Impairment of Daily Activities

  Severe symptom period (from 23Feb2018 to 24Mar2018)

Study Arms (2)

Omalizumab

EXPERIMENTAL

Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks

Drug: Omalizumab

Placebo

PLACEBO COMPARATOR

Eligible patients randomized to this arm received placebo subcutaneously for 12 weeks

Drug: Placebo

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.

Omalizumab

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.

Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (22)

Novartis Investigative Site

Chiba, Chiba, 262-0015, Japan

Location

Novartis Investigative Site

Ichikawa, Chiba, 272-0143, Japan

Location

Novartis Investigative Site

Kashiwa, Chiba, 2270082, Japan

Location

Novartis Investigative Site

Matsudo, Chiba, 270-0034, Japan

Location

Novartis Investigative Site

Matsudo, Chiba, 2710077, Japan

Location

Novartis Investigative Site

Urayasu, Chiba, 279-0012, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 212-0027, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 216 0006, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 216-0002, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Location

Novartis Investigative Site

Koshigaya, Saitama, 343-0031, Japan

Location

Novartis Investigative Site

Arakawa-ku, Tokyo, 116 0011, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Tokyo, 101-0063, Japan

Location

Novartis Investigative Site

Chuo Ku, Tokyo, 103 0027, Japan

Location

Novartis Investigative Site

Edogawa-ku, Tokyo, 132-0014, Japan

Location

Novartis Investigative Site

Katsushika-ku, Tokyo, 125-0061, Japan

Location

Novartis Investigative Site

Nakano-ku, Tokyo, 164-0012, Japan

Location

Novartis Investigative Site

Setagaya-ku, Tokyo, 158-0097, Japan

Location

Novartis Investigative Site

Shinjuku Ku, Tokyo, 160-0008, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-0017, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Location

Novartis Investigative Site

Toshima-Ku, Tokyo, 170-0005, Japan

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicatrials.com
• A Pediatric Plain Language Trial Summary is available on novartisclinicatrials.com

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 12, 2017
• Study Start: December 15, 2017
• Primary Completion: May 11, 2018
• Study Completion: October 20, 2018
• Last Updated: January 12, 2026
• Results First Posted: November 4, 2019

Record last verified: 2025-12

Locations

JP (22)