Trial Outcomes & Findings for Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients (NCT NCT03369704)

NCT ID: NCT03369704

Last Updated: 2026-01-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 337 participants
• Primary outcome timeframe: Severe symptom period (from 23Feb2018 to 24March2018)
• Results posted on: 2026-01-12

Participant Flow

This study was conducted at 22 centers in Kanto-area of Japan.

337 patients were randomized

Participant milestones

Measure	Omalizumab Omalizumab administered subcutaneously for 12 weeks	Placebo Placebo administered subcutaneously for 12 weeks
Treatment Epoch STARTED	162	175
Treatment Epoch COMPLETED	158	172
Treatment Epoch NOT COMPLETED	4	3
Follow-up Epoch STARTED	161	174
Follow-up Epoch COMPLETED	160	174
Follow-up Epoch NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Omalizumab Omalizumab administered subcutaneously for 12 weeks	Placebo Placebo administered subcutaneously for 12 weeks
Treatment Epoch technical problems	1	0
Treatment Epoch Protocol Violation	1	0
Treatment Epoch Lost to Follow-up	0	1
Treatment Epoch Lack of Efficacy	0	2
Treatment Epoch Adverse Event	2	0
Follow-up Epoch Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Omalizumab n=162 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=175 Participants Placebo administered subcutaneously for 12 weeks	Total n=337 Participants Total of all reporting groups
Age, Customized < 15 years	4 Participants n=210 Participants	6 Participants n=19 Participants	10 Participants n=8 Participants
Age, Customized 15 <=, < 65 years	149 Participants n=210 Participants	158 Participants n=19 Participants	307 Participants n=8 Participants
Age, Customized >= 65 years	9 Participants n=210 Participants	11 Participants n=19 Participants	20 Participants n=8 Participants
Sex: Female, Male Female	99 Participants n=210 Participants	97 Participants n=19 Participants	196 Participants n=8 Participants
Sex: Female, Male Male	63 Participants n=210 Participants	78 Participants n=19 Participants	141 Participants n=8 Participants
Race/Ethnicity, Customized Asian	162 Participants n=210 Participants	175 Participants n=19 Participants	337 Participants n=8 Participants

PRIMARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24March2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

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.

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Mean Nasal Symptom Score	3.66 score Standard Error 0.151	4.69 score Standard Error 0.144

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24Mar2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

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.

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score Mean ocular symptom score	2.45 Score Standard Error 0.115	3.32 Score Standard Error 0.110
Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score Mean nasal ocular symptom score	6.11 Score Standard Error 0.240	8.01 Score Standard Error 0.228

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24Mar2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

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).

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score Mean nasal symptom medication score	6.19 score Standard Error 0.166	7.29 score Standard Error 0.158
Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score Mean ocular symptom medication score	3.91 score Standard Error 0.137	4.86 score Standard Error 0.130
Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score Mean nasal ocular symptom medication score	9.10 score Standard Error 0.271	11.15 score Standard Error 0.259

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24Mar2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

Symptoms of sneezing, rhinorrhea and nasal congestion were evaluated on a scale of 0 (none) to 4 (intense/severe).

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion Mean nasal congestion score	1.05 score Standard Error 0.058	1.34 score Standard Error 0.056
Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion Mean sneezing score	1.15 score Standard Error 0.053	1.56 score Standard Error 0.050
Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion Mean rhinorrhea score	1.46 score Standard Error 0.063	1.79 score Standard Error 0.060

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24Mar2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

Symptoms of itchy and watery eye were evaluated on a scale of 0 (none) to 4 (intense/severe).

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Mean Score for Severity of Itchy and Watery Eye Mean watery eye score	0.98 score Standard Error 0.063	1.38 score Standard Error 0.060
Mean Score for Severity of Itchy and Watery Eye Mean itchy eye score	1.47 score Standard Error 0.061	1.94 score Standard Error 0.058

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24Mar2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

Impairment of daily activities were evaluated on a scale of 0 (none) to 4 (intense/severe).

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Mean Score for Impairment of Daily Activities	1.09 score Standard Error 0.052	1.43 score Standard Error 0.050

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24March2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

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.

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Number of Symptom Free Days Nasal symptom free days	15 days Interval 0.0 to 30.0	10 days Interval 0.0 to 30.0
Number of Symptom Free Days Ocular symptom free days	12 days Interval 0.0 to 30.0	6 days Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24Mar2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

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.

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Completely Nasal Symptom Free Patients	13 Participants	4 Participants

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24Mar2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

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

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Rescue Medication Score Nasal rescue medication score	0.20 score Standard Error 0.024	0.28 score Standard Error 0.023
Rescue Medication Score Ocular rescue medication score	0.46 score Standard Error 0.029	0.54 score Standard Error 0.027
Rescue Medication Score Nasal ocular rescue medication score	0.66 score Standard Error 0.045	0.82 score Standard Error 0.043

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24Mar2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

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).

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Rescue Medication Free Days Nasal rescue medication free days	27.0 days Interval 0.0 to 30.0	23.5 days Interval 0.0 to 30.0
Rescue Medication Free Days Ocular rescue medication free days	16.0 days Interval 0.0 to 30.0	11.0 days Interval 0.0 to 30.0
Rescue Medication Free Days Nasal ocular rescue medication free days	12.5 days Interval 0.0 to 30.0	9.0 days Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: Severe symptom period (from 23Feb2018 to 24Mar2018)

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.

Amount number of rescue medication used (a total number of times used).

Outcome measures

Measure	Omalizumab n=158 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=174 Participants Placebo administered subcutaneously for 12 weeks
Number of Rescue Medication Used Number of ocular rescue medication used	18.5 Number of times used Interval 0.0 to 109.0	28.5 Number of times used Interval 0.0 to 113.0
Number of Rescue Medication Used Number of rescue nasal medication used	1.0 Number of times used Interval 0.0 to 120.0	6.0 Number of times used Interval 0.0 to 109.0

SECONDARY outcome

Timeframe: Evaluation Visit, one visit during severe symptom period (23-Feb-2018 to 24-Mar-2018) for each patient

Population: Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug.

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.

Outcome measures

Measure	Omalizumab n=160 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=175 Participants Placebo administered subcutaneously for 12 weeks
Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score Nasal and eye symptoms (JRQLQ I)	1.27 Score Standard Error 0.062	1.76 Score Standard Error 0.059
Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score Mean score of QoL-related questionnaire (JRQLQ II)	0.70 Score Standard Error 0.067	1.20 Score Standard Error 0.064
Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score Overall face scale (JRQLQ III)	1.6 Score Standard Error 0.08	2.2 Score Standard Error 0.07

SECONDARY outcome

Timeframe: Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch

Population: Safety set (SAF): The SAF consisted of all patients who received at least 1 dose of study drug. Patients in the SAF were analyzed according to treatment actually received.

Number of participants with antibodies against the Fab and Fc region of omalizumab in serum.

Outcome measures

Measure	Omalizumab n=161 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=175 Participants Placebo administered subcutaneously for 12 weeks
Number of Participants With Anti-omalizumab Antibodes Anti-Fc-(post-dose)	0 participants	2 participants
Number of Participants With Anti-omalizumab Antibodes Anti-Fab (post dose)	0 participants	0 participants
Number of Participants With Anti-omalizumab Antibodes Anti-Fc-(pre-dose)	1 participants	2 participants
Number of Participants With Anti-omalizumab Antibodes Anti-Fab-(pre-dose)	0 participants	0 participants

SECONDARY outcome

Timeframe: Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose

Population: Pharmacokinetic set (PK set): The PK set consisted of all randomized patients who received at least 1 dose of study drug and had at least 1 evaluable PK measurement. Patients in the PK set were analyzed according to the treatment they actually received.

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

Outcome measures

Measure	Omalizumab n=161 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo Placebo administered subcutaneously for 12 weeks
Serum Trough Omalizumab Concentration Day 1 (pre-dose)	0 μg/mL Standard Deviation 0	—
Serum Trough Omalizumab Concentration Day 29	42.6 μg/mL Standard Deviation 34.8	—
Serum Trough Omalizumab Concentration Day 57	54.1 μg/mL Standard Deviation 42.3	—
Serum Trough Omalizumab Concentration Day 85	66.3 μg/mL Standard Deviation 49.0	—
Serum Trough Omalizumab Concentration Day 225/239	0.928 μg/mL Standard Deviation 1.11	—

SECONDARY outcome

Timeframe: Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose

Population: Pharmacokinetic set (PK set): The PK set consisted of all randomized patients who received at least 1 dose of study drug and had at least 1 evaluable PK measurement. Patients in the PK set were analyzed according to the treatment they actually received.

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

Outcome measures

Measure	Omalizumab n=161 Participants Omalizumab administered subcutaneously for 12 weeks	Placebo n=175 Participants Placebo administered subcutaneously for 12 weeks
Free IgE and Total IgE Free IgE (Day 1 predose)	NA ng/mL Standard Deviation NA NA= Not Available. A result is NA when \> 1/3 of the values were above ULOQ (upper limit of quantification). ULOQ defined as 150 ng/mL for free IgE	NA ng/mL Standard Deviation NA NA= Not Available. A result is NA when \> 1/3 of the values were above ULOQ (upper limit of quantification). ULOQ defined as 150 ng/mL for free IgE
Free IgE and Total IgE Free IgE (Day 29)	21.3 ng/mL Standard Deviation 9.8	NA ng/mL Standard Deviation NA NA= Not Available. A result is NA when \> 1/3 of the values were above ULOQ (upper limit of quantification). ULOQ defined as 150 ng/mL for free IgE
Free IgE and Total IgE Free IgE (Day 57)	20.8 ng/mL Standard Deviation 10.1	NA ng/mL Standard Deviation NA NA= Not Available. A result is NA when \> 1/3 of the values were above ULOQ (upper limit of quantification). ULOQ defined as 150 ng/mL for free IgE
Free IgE and Total IgE Free IgE (Day 85)	18.6 ng/mL Standard Deviation 11.9	NA ng/mL Standard Deviation NA NA= Not Available. A result is NA when \> 1/3 of the values were above ULOQ (upper limit of quantification). ULOQ defined as 150 ng/mL for free IgE
Free IgE and Total IgE Free IgE (Day 225/239)	NA ng/mL Standard Deviation NA NA= Not Available. A result is NA when \> 1/3 of the values were above ULOQ (upper limit of quantification). ULOQ defined as 150 ng/mL for free IgE	NA ng/mL Standard Deviation NA NA= Not Available. A result is NA when \> 1/3 of the values were above ULOQ (upper limit of quantification). ULOQ defined as 150 ng/mL for free IgE
Free IgE and Total IgE Total IgE (Day 1 pre-dose)	524 ng/mL Standard Deviation 531	570 ng/mL Standard Deviation 641
Free IgE and Total IgE Total IgE (Day 29)	2040 ng/mL Standard Deviation 1620	558 ng/mL Standard Deviation 608
Free IgE and Total IgE Total IgE (Day 57)	2160 ng/mL Standard Deviation 1660	640 ng/mL Standard Deviation 721
Free IgE and Total IgE Total IgE (Day 85)	1960 ng/mL Standard Deviation 1480	673 ng/mL Standard Deviation 775
Free IgE and Total IgE Total IgE (Day 225/239)	702 ng/mL Standard Deviation 639	669 ng/mL Standard Deviation 783

Adverse Events

IGE025

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	IGE025 n=161 participants at risk Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks	Placebo n=175 participants at risk Placebo administered subcutaneously for 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular neoplasm	0.62% 1/161 • Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months. Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.	0.00% 0/175 • Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months. Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.

Other adverse events

Measure	IGE025 n=161 participants at risk Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks	Placebo n=175 participants at risk Placebo administered subcutaneously for 12 weeks
Infections and infestations Influenza	2.5% 4/161 • Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months. Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.	4.6% 8/175 • Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months. Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.
Infections and infestations Nasopharyngitis	9.3% 15/161 • Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months. Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.	4.6% 8/175 • Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months. Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.
Infections and infestations Pharyngitis	4.3% 7/161 • Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months. Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.	2.9% 5/175 • Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months. Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER