Trial Outcomes & Findings for EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients (NCT NCT04998604)
NCT ID: NCT04998604
Last Updated: 2025-10-23
Results Overview
The NPS was assessed by the independent physician to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. The NPS scores for each nostril was graded based on polyp size from 0 (no polyps) to 4 (large polyps causing complete obstruction of the inferior nasal cavity). The total NPS score was calculated as the sum of right and left nostril scores and ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicated more extensive or severe nasal polyps. Negative change from baseline indicated less severity of nasal polyps. Baseline was defined as the last available valid (non-missing) value up to and including the day of first administration of study treatment.
COMPLETED
PHASE4
360 participants
Baseline (Day 1) and Week 24
2025-10-23
Participant Flow
The study was conducted at 87 active centers in 17 countries. A total of 819 participants were screened between 27 September 2021 and 25 April 2024, of which 459 participants were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
A total of 360 participants were randomized in a 1:1 ratio to receive either dupilumab or omalizumab in the study. Randomization was stratified by prior surgery for nasal polyp, inhaled corticosteroids (ICS) doses (low versus medium/high dose ICS), presence of aspirin-exacerbated respiratory disease (AERD) and region \[Eastern European (EE) versus Rest of the World (ROW)\].
Participant milestones
| Measure |
Dupilumab 300 mg Q2W
Participants received dupilumab 300 milligrams (mg) subcutaneous (SC) injection every 2 weeks (Q2W) for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
Participants received omalizumab 75 to 600 mg SC injection Q2W/every 4 weeks (Q4W) based on their serum immunoglobulin E (IgE) levels and body weight for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
181
|
179
|
|
Overall Study
Randomized and Treated
|
179
|
173
|
|
Overall Study
COMPLETED
|
174
|
165
|
|
Overall Study
NOT COMPLETED
|
7
|
14
|
Reasons for withdrawal
| Measure |
Dupilumab 300 mg Q2W
Participants received dupilumab 300 milligrams (mg) subcutaneous (SC) injection every 2 weeks (Q2W) for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
Participants received omalizumab 75 to 600 mg SC injection Q2W/every 4 weeks (Q4W) based on their serum immunoglobulin E (IgE) levels and body weight for 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Not related to coronavirus disease 2019 pandemic
|
2
|
8
|
Baseline Characteristics
Only number of participants evaluable for the specified baseline measure are reported.
Baseline characteristics by cohort
| Measure |
Dupilumab 300 mg Q2W
n=181 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=179 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 13.33 • n=181 Participants
|
52.1 years
STANDARD_DEVIATION 12.90 • n=179 Participants
|
51.5 years
STANDARD_DEVIATION 13.11 • n=360 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=181 Participants
|
88 Participants
n=179 Participants
|
162 Participants
n=360 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=181 Participants
|
91 Participants
n=179 Participants
|
198 Participants
n=360 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=181 Participants
|
2 Participants
n=179 Participants
|
2 Participants
n=360 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=181 Participants
|
1 Participants
n=179 Participants
|
2 Participants
n=360 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=181 Participants
|
1 Participants
n=179 Participants
|
3 Participants
n=360 Participants
|
|
Race/Ethnicity, Customized
White
|
171 Participants
n=181 Participants
|
170 Participants
n=179 Participants
|
341 Participants
n=360 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=181 Participants
|
1 Participants
n=179 Participants
|
1 Participants
n=360 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
6 Participants
n=181 Participants
|
2 Participants
n=179 Participants
|
8 Participants
n=360 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=181 Participants
|
2 Participants
n=179 Participants
|
3 Participants
n=360 Participants
|
|
Nasal Polyp Score (NPS)
|
6.11 score on a scale
STANDARD_DEVIATION 1.165 • n=181 Participants
|
6.15 score on a scale
STANDARD_DEVIATION 1.277 • n=179 Participants
|
6.13 score on a scale
STANDARD_DEVIATION 1.220 • n=360 Participants
|
|
University of Pennsylvania Smell Identification Test (UPSIT)
|
11.1 score on a scale
STANDARD_DEVIATION 5.45 • n=180 Participants • Only number of participants evaluable for the specified baseline measure are reported.
|
11.0 score on a scale
STANDARD_DEVIATION 6.13 • n=175 Participants • Only number of participants evaluable for the specified baseline measure are reported.
|
11.1 score on a scale
STANDARD_DEVIATION 5.79 • n=355 Participants • Only number of participants evaluable for the specified baseline measure are reported.
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
The NPS was assessed by the independent physician to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. The NPS scores for each nostril was graded based on polyp size from 0 (no polyps) to 4 (large polyps causing complete obstruction of the inferior nasal cavity). The total NPS score was calculated as the sum of right and left nostril scores and ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicated more extensive or severe nasal polyps. Negative change from baseline indicated less severity of nasal polyps. Baseline was defined as the last available valid (non-missing) value up to and including the day of first administration of study treatment.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=172 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=165 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Nasal Polyp Score
|
-2.65 score on a scale
Interval -2.95 to -2.36
|
-1.05 score on a scale
Interval -1.35 to -0.75
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
The UPSIT was a 40-item test to quantitatively assess human olfactory function. The UPSIT test consisted of 4 booklets, each containing 10 odorants with 1 odorant per page. The participant was asked to release the odorant by rubbing the brown-strip (contained odorant microcapsules) with the tip of a pencil and to indicate which of 4 words best described the odor. Thus, each participant received a score out of 40 possible correct answers. The total UPSIT score ranged from 0 (loss of smell/anosmia) to 40 (normal sense of smell/normosmia). Higher scores indicated better olfactory function. Positive change from baseline indicated normal olfactory function. Baseline was defined as the last available valid (non-missing) value up to and including the day of first administration of study treatment.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=173 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=166 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in University of Pennsylvania Smell Identification Test
|
12.7 score on a scale
Interval 11.3 to 14.1
|
4.7 score on a scale
Interval 3.2 to 6.1
|
SECONDARY outcome
Timeframe: Baseline (average of Day -6 to Day 1) and Week 24Population: The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
The nasal symptom diary was designed to assess the severity of chronic rhinosinusitis nasal symptoms daily. These symptoms included nasal congestion (NC)/obstruction, loss of smell, anterior rhinorrhea, and posterior rhinorrhea. The severity of loss of smell was scored by participants using a scale ranged from 0 to 3 (where, 0= no symptoms, 1= mild symptoms, 2= moderate symptoms and 3= severe symptoms that were hard to tolerate, caused interference with activities, or daily living). Higher scores indicated greater symptom severity. Negative change from baseline indicated less severe symptom. Baseline value was calculated by averaging the data collected/recorded from Day -6 to Day 1.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=170 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=164 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in the Loss of Smell Score of the Chronic Rhinosinusitis With Nasal Polyp (CRSwNP) Nasal Symptom Diary
|
-1.55 score on a scale
Interval -1.71 to -1.38
|
-0.74 score on a scale
Interval -0.9 to -0.57
|
SECONDARY outcome
Timeframe: Baseline (average of Day -6 to Day 1) and Week 24Population: The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
The nasal symptom diary was designed to assess the severity of chronic rhinosinusitis nasal symptoms daily. These symptoms included NC/obstruction, loss of smell, anterior rhinorrhea, and posterior rhinorrhea. The severity of NC was scored by participants using a scale ranged from 0 to 3 (where, 0= no symptoms, 1= mild symptoms, 2= moderate symptoms and 3= severe symptoms that were hard to tolerate, caused interference with activities, or daily living). Higher scores indicated greater symptom severity. Negative change from baseline indicated less severe symptom. Baseline value was calculated by averaging the data collected/recorded from Day -6 to Day 1.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=170 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=164 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in the Nasal Congestion Score of the Chronic Rhinosinusitis With Nasal Polyp Nasal Symptom Diary
|
-1.63 score on a scale
Interval -1.76 to -1.49
|
-1.05 score on a scale
Interval -1.18 to -0.91
|
SECONDARY outcome
Timeframe: Baseline (average of Day -6 to Day 1) and Week 24Population: The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
The TSS is a composite score consisted of the following symptoms assessed daily in the morning: NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (average of anterior/posterior nasal discharge). Each item was scored on a scale ranged from 0 to 3 (where, 0= no symptoms, 1= mild symptoms, 2= moderate symptoms and 3= severe symptoms that were hard to tolerate, and caused interference with activities, or daily living). Higher score indicated greater symptom severity. The TSS score was calculated by summing the individual symptom score and ranged from 0 (no symptoms) to 9 (severe symptoms). Higher scores on the TSS indicated greater symptom severity. Negative change from baseline indicated less severe symptom. Baseline was calculated by averaging the data collected/recorded from Day -6 to Day 1.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=170 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=164 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Total Symptom Score (TSS) Derived From the Chronic Rhinosinusitis With Nasal Polyp Nasal Symptom Diary
|
-4.48 score on a scale
Interval -4.82 to -4.14
|
-2.73 score on a scale
Interval -3.09 to -2.38
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
The SNOT-22 is a patient-reported outcome questionnaire designed to assess the impact of chronic rhinosinusitis on participants' health-related quality of life. The SNOT-22 consisted of 22 items covering symptoms, social/emotional impact, productivity, and sleep consequences of chronic rhinosinusitis. Each item was rated on a 6-point Likert scale response option, score ranged from 0 (no problem) to 5 (problem as bad as it can be). The SNOT-22 total score was the sum of each item score, and it ranged from 0 (no problem) to 110 (problem as bad as it can be). Higher scores indicated greater rhinosinusitis-related health burden, meaning for this parameter lower score indicated better condition. Negative change from baseline indicated improvement in health-related quality of life. Baseline was defined as the last available valid (non-missing) value up to and including the day of first administration of study treatment.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=161 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=158 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Sino-Nasal Outcome Test 22-Items (SNOT-22) Total Score
|
-44.6 score on a scale
Interval -47.9 to -41.3
|
-31.9 score on a scale
Interval -35.2 to -28.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
SNOT-22 is a patient-reported outcome questionnaire designed to assess impact of chronic rhinosinusitis on participants' health-related quality of life. SNOT-22 was categorized into 5 domains: Nasal (items 1, 2, 3, 4, 5, 6, 7 and 12); Ear/Facial (items 8, 9, 10 and 11); Sleep (items 13, 14, 15 and 16); Function (items 17, 18 and 19); Emotion (items 20, 21 and 22). Each item of Nasal domain was rated on a 6-point Likert scale ranged from 0 (no problem) to 5 (problem as bad as it can be) with higher score indicated greater rhinosinusitis-related health burden. Total score of Nasal domain was average score of items of nasal domain, and ranged from 0 (no problem) to 5 (problem as bad as it can be), where higher score indicated greater rhinosinusitis-related health burden. Negative change from baseline indicated improvement in health-related quality of life. Baseline was defined as last available valid (non-missing) value up to and including day of first administration of study treatment.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=161 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=158 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Sino-Nasal Outcome Test 22-Items: Nasal Domain Score
|
-2.4 score on a scale
Interval -2.6 to -2.2
|
-1.6 score on a scale
Interval -1.8 to -1.4
|
SECONDARY outcome
Timeframe: Baseline (average of Day -6 to Day 1) and Week 24Population: The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
The NPIF evaluation represented a physiologic measure of the air flow through both nasal cavities during forced inspiration. The NPIF is the best validated technique for the evaluation of nasal flow through the nose. Participants were issued an NPIF meter and were instructed on the use of the device and written instructions on the use of the NPIF meter was provided. Higher NPIF values were indicative of better nasal air flow. Positive change from baseline indicated better nasal air flow. Baseline was the mean measurement recorded for the 7 days (Day -6 to Day 1) prior to first dose of study treatment.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=169 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=163 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Nasal Peak Inspiratory Flow (NPIF)
|
68.96 Liters per minute
Interval 60.9 to 77.02
|
37.69 Liters per minute
Interval 29.28 to 46.09
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
The rhinosinusitis severity VAS was used to evaluate the overall severity of the rhinosinusitis. It is a recommended scale to determine the participant's disease severity and to guide the treatment for chronic rhinosinusitis. The participants were asked to answer the following question: "How troublesome are your symptoms of your rhinosinusitis" on a 10-centimeter VAS from 0 (not troublesome) to 10 (worst thinkable troublesome). Higher scores on the VAS score indicated more severe chronic rhinosinusitis. Negative change from baseline indicated less severity of rhinosinusitis. Baseline was defined as the last available valid (non-missing) value up to and including the day of first administration of study treatment.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=161 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=158 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Rhinosinusitis Visual Analogue Scale (Rhinosinusitis VAS)
|
-5.43 units on a scale
Interval -5.96 to -4.9
|
-3.56 units on a scale
Interval -4.11 to -3.01
|
SECONDARY outcome
Timeframe: From first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 daysPopulation: The Safety analysis set included all randomized participants who received at least 1 dose of study treatment.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. The TEAEs was defined as an AEs that occurred from the first administration of the study treatment (on Day 1) up to 98 days after the last dose of study treatment administration.
Outcome measures
| Measure |
Dupilumab 300 mg Q2W
n=179 Participants
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=173 Participants
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)
Any TEAE
|
115 Participants
|
116 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)
Any Serious TEAE
|
3 Participants
|
7 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)
Any Treatment-Emergent AESI
|
4 Participants
|
2 Participants
|
Adverse Events
Dupilumab 300 mg Q2W
Omalizumab 75 to 600 mg Q2W/Q4W
Serious adverse events
| Measure |
Dupilumab 300 mg Q2W
n=179 participants at risk
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=173 participants at risk
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/179 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.58%
1/173 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.56%
1/179 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.00%
0/173 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Immune system disorders
Eosinophilic Granulomatosis With Polyangiitis
|
0.00%
0/179 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.58%
1/173 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/179 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.58%
1/173 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Mycobacterium Avium Complex Infection
|
0.56%
1/179 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.00%
0/173 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Neuroborreliosis
|
0.00%
0/179 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.58%
1/173 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/179 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
1.2%
2/173 • Number of events 2 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Pneumonia Klebsiella
|
0.56%
1/179 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.00%
0/173 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/179 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.58%
1/173 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.56%
1/179 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.00%
0/173 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Vascular disorders
Granulomatosis With Polyangiitis
|
0.56%
1/179 • Number of events 1 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
0.00%
0/173 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
Other adverse events
| Measure |
Dupilumab 300 mg Q2W
n=179 participants at risk
Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.
|
Omalizumab 75 to 600 mg Q2W/Q4W
n=173 participants at risk
Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.7%
21/179 • Number of events 25 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
11.6%
20/173 • Number of events 22 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.6%
10/179 • Number of events 12 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
4.6%
8/173 • Number of events 8 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
6.7%
12/179 • Number of events 14 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
12.1%
21/173 • Number of events 24 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
|
Nervous system disorders
Headache
|
5.6%
10/179 • Number of events 12 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
7.5%
13/173 • Number of events 17 • Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Analysis was performed on the safety analysis set.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER