Seasonal Allergic RhinitisPhase 3NCT03369704
Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients
A Phase 3 study testing Omalizumab in people with Seasonal Allergic Rhinitis, run by Novartis Pharmaceuticals at 22 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 337 participants
- Where
- 22 sitesJapan
- Study dates
- 15 Dec 2017to 20 Oct 2018
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Japan22 sites
Novartis Investigative Site
Arakawa-ku, Tokyo, 116 0011
Novartis Investigative Site
Chiba, Chiba, 262-0015
Novartis Investigative Site
Chiyoda-ku, Tokyo, 101-0063
Novartis Investigative Site
Chuo Ku, Tokyo, 103 0027
Novartis Investigative Site
Edogawa-ku, Tokyo, 132-0014
Novartis Investigative Site
Ichikawa, Chiba, 272-0143
Novartis Investigative Site
Kashiwa, Chiba, 2270082
Novartis Investigative Site
Katsushika-ku, Tokyo, 125-0061
Novartis Investigative Site
Kawasaki, Kanagawa, 212-0027
Novartis Investigative Site
Kawasaki, Kanagawa, 216 0006
Novartis Investigative Site
Kawasaki, Kanagawa, 216-0002
Novartis Investigative Site
Koshigaya, Saitama, 343-0031
Novartis Investigative Site
Matsudo, Chiba, 270-0034
Novartis Investigative Site
Matsudo, Chiba, 2710077
Novartis Investigative Site
Nakano-ku, Tokyo, 164-0012
Novartis Investigative Site
Setagaya-ku, Tokyo, 158-0097
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0008
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0017
Novartis Investigative Site
Shinjuku-ku, Tokyo
Novartis Investigative Site
Toshima-Ku, Tokyo, 170-0005
Novartis Investigative Site
Urayasu, Chiba, 279-0012
Novartis Investigative Site
Yokohama, Kanagawa
About this study
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
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
- Being tested
- Omalizumab, Placebo
- Keywords
- cryptomeria, omalizumab, seasonal allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks Receives: Drug: Omalizumab |
| Placebo | Placebo comparator | Eligible patients randomized to this arm received placebo subcutaneously for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Severe symptom period (from 23Feb2018 to 24March2018)
Secondary outcomes (14)
Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score
Ocular symptoms (itchy and watery eye) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Ocular symptom score (0-8 point) consisted of score for severity of itchy eye (0-4 point) and watery eye (0-4 point).
Nasal ocular symptom score consisted of nasal symptom score and ocular symptom score.
Nasal ocular symptom score is the sum of nasal symptom score (0-12) and ocular symptom score (0-8) 0 presents no nasal ocular symptom and 20 presents worse outcome.
Measured: Severe symptom period (from 23Feb2018 to 24Mar2018)
Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score
Medication scores were given for fluticasone propionate (nasal, 2 point), fexofenadine hydrochloride (oral, 1 point), tramazoline hydrochloride (nasal, 1 point), and levocabastine hydrochloride (ocular, 1 point). Symptom medication score consisted of severe symptom period.
Nasal symptom medication score is the sum of nasal symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride) Ocular symptom medication score is the sum of ocular symptom score and medication score (fexofenadine hydrochloride, levocabastine hydrochloride) Nasal ocular symptom medication score is the sum of nasal symptom score, ocular symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride, levocabastine hydrochloride).
Measured: Severe symptom period (from 23Feb2018 to 24Mar2018)
Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion
Symptoms of sneezing, rhinorrhea and nasal congestion were evaluated on a scale of 0 (none) to 4 (intense/severe).
Measured: Severe symptom period (from 23Feb2018 to 24Mar2018)
Mean Score for Severity of Itchy and Watery Eye
Symptoms of itchy and watery eye were evaluated on a scale of 0 (none) to 4 (intense/severe).
Measured: Severe symptom period (from 23Feb2018 to 24Mar2018)
Mean Score for Impairment of Daily Activities
Impairment of daily activities were evaluated on a scale of 0 (none) to 4 (intense/severe).
Measured: Severe symptom period (from 23Feb2018 to 24Mar2018)
Number of Symptom Free Days
Nasal symptom free days (days with all nasal symptoms are not more than mild in severity) during the severe symptom period. Ocular symptom free days (days with all ocular symptoms are not more than mild in severity) during the severe symptom period.
Measured: Severe symptom period (from 23Feb2018 to 24March2018)
Completely Nasal Symptom Free Patients
Completely nasal symptom free patients is the number of patients who were nasal symptom free (all nasal symptoms were not more than mild in severity) on all non-missing days and had nasal symptom scores for at least 26 days during the 30 days of severe symptom period.
Measured: Severe symptom period (from 23Feb2018 to 24Mar2018)
Rescue Medication Score
Rescue medication scores were given for tramazoline hydrochloride (nasal, 1 point) and levocabastine hydrochloride (ocular, 1 point).
Rescue medication score for nasal is medication score for Tramazoline hydrochloride, Rescue medication score for ocular is medication score for Levocabastine hydrochloride and Rescue medication score for nasal and ocular is the sum of medication score for Tramazoline hydrochloride and Levocabastine hydrochlorid
Measured: Severe symptom period (from 23Feb2018 to 24Mar2018)
Rescue Medication Free Days
Number of days with no rescue medication (tramazoline hydrochloride, levocabastine hydrochloride).
Nasal ocular rescue medication free days were defined as the days with no use of tramazoline hydrochloride (nasal rescue medication) and levocabastine hydrochloride (ocular rescue medication).
Measured: Severe symptom period (from 23Feb2018 to 24Mar2018)
Number of Rescue Medication Used
Amount number of rescue medication used (a total number of times used).
Measured: Severe symptom period (from 23Feb2018 to 24Mar2018)
Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score
Nasal and eye symptoms (JRQLQ I) included 6 categories: Runny nose, Sneezing, Nasal congestion, Itchy nose, itchy eyes and watery eyes, on a 5-point scale of 0 to 4 (no symptoms to very severe symptoms). JRQLQ I score was a mean of these 6 categories. JRQLQ II included 17 items on a 5-point scale, 0 to 4 (no significant problem to very greatly). JRQLQ II scores was a mean of these 17 items. Overall face scale (JRQLQ III) evaluated overall symptoms, condition and feelings on a 5-point scale from 0 to 4 (fine to crying). Evaluation visit was defined as follows independently for each evaluation item and for each patient: 1) If there was a single visit during the severe symptom period, the visit was the evaluation visit. 2) If there were ≥ 2 visits during the severe symptom period and a) if Visit 105 was one of them, Visit 105 was the evaluation visit; b) if Visit 105 was outside the period, the closest visit to Visit 105 during the period was the evaluation visit.
Measured: Evaluation Visit, one visit during severe symptom period (23-Feb-2018 to 24-Mar-2018) for each patient
Number of Participants With Anti-omalizumab Antibodes
Number of participants with antibodies against the Fab and Fc region of omalizumab in serum.
Measured: Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch
Serum Trough Omalizumab Concentration
Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch
Measured: Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose
Free IgE and Total IgE
Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation were conducted 20/22 weeks after 12 week-treatment epoch
Measured: Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start15 Dec 2017
- Primary completion11 May 2018
- Study completion20 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369704
- Sponsor's protocol ID
- CIGE025F1301
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2017
- Last updated
- 12 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com