Trial Outcomes & Findings for Dupilumab in Chinese Adult Participants With CRSwNP (NCT NCT05878093)
NCT ID: NCT05878093
Last Updated: 2025-09-25
Results Overview
The NPS was the sum of the right and left nostril scores and assessed by central video recordings of bilateral nasal endoscopy. For each nostril, NPS was graded based on polyp size which ranged from 0: no polyps, 1: small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2: polyps reaching below the lower border of the middle turbinate, 3: large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, 4: large polyps causing complete obstruction of the inferior nasal cavity. Total NPS was the sum of right and left nostril scores; ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicated more severe disease. Baseline was defined as the last available value before randomization.
COMPLETED
PHASE3
63 participants
Baseline (Day 1) and Week 24
2025-09-25
Participant Flow
The study was conducted at 18 centers in China. A total of 151 participants were screened from 16 May 2023 to 27 February 2024, of which 88 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
A total of 63 participants were randomized in a 1:1 ratio to receive either matching placebo or dupilumab. Randomization was stratified by screening blood eosinophil count (\>=300 cells per cubic millimeter \[/mm\^3\] or \<300 cells/mm\^3).
Participant milestones
| Measure |
Placebo
Participants received placebo matched to dupilumab subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
Participants received dupilumab 300 milligrams (mg) SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to dupilumab subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
Participants received dupilumab 300 milligrams (mg) SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Dupilumab in Chinese Adult Participants With CRSwNP
Baseline characteristics by cohort
| Measure |
Placebo
n=32 Participants
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 Participants
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Nasal Polyps Score (NPS)
|
5.84 score on a scale
STANDARD_DEVIATION 1.60 • n=5 Participants
|
5.53 score on a scale
STANDARD_DEVIATION 1.41 • n=7 Participants
|
5.69 score on a scale
STANDARD_DEVIATION 1.51 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not.
The NPS was the sum of the right and left nostril scores and assessed by central video recordings of bilateral nasal endoscopy. For each nostril, NPS was graded based on polyp size which ranged from 0: no polyps, 1: small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2: polyps reaching below the lower border of the middle turbinate, 3: large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, 4: large polyps causing complete obstruction of the inferior nasal cavity. Total NPS was the sum of right and left nostril scores; ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicated more severe disease. Baseline was defined as the last available value before randomization.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 Participants
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Nasal Polyps Score at Week 24
|
-0.50 score on a scale
Standard Error 0.30
|
-2.34 score on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline (Day -7 to Day -1) and Week 24Population: The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not.
The NCS was a patient reported outcome to evaluate nasal congestion/obstruction, a major clinical symptom in chronic rhinosinusitis phenotype with nasal polyps. The NCS was assessed by the participant on a daily basis from visit 1 and throughout the study. It consisted of a 0 to 3 categorical scale, where 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms. Higher scores indicated more severity. The Week 24 analysis score was calculated as the average of all scores during the 4 weeks before Week 24. Baseline was defined as the average of the scores in the 7 days prior to randomization.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 Participants
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Nasal Congestion/Obstruction Score (NCS) at Week 24
|
-0.52 score on a scale
Standard Error 0.18
|
-1.06 score on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline (Day -7 to Day -1) and Week 24Population: The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not.
The TSS was a reflective score of the worst symptom severity over the past 24 hours by the participant. It was assessed by the participant on a daily basis from visit 1 and throughout the study. It consisted of the sum of the following rhinosinusitis symptom questions: nasal congestion, decreased/loss of sense of smell, rhinorrhea (average of anterior/posterior nasal discharge); each assessed on 0 to 3 categorical scale, where 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms. The TSS was a composite score by summing the above symptom scores and ranged from 0 (no symptoms) to 9 (severe symptoms). Higher scores indicated greater overall symptom severity. The Week 24 analysis score was calculated as the average of all scores during the 4 weeks before Week 24. Baseline was defined as the average of the scores in the 7 days prior to randomization.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 Participants
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Total Symptoms Score (TSS) at Week 24
|
-1.07 score on a scale
Standard Error 0.43
|
-2.75 score on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline (Day -7 to Day -1) and Week 24Population: The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not.
The decreased/loss of sense of smell severity was a reflective score of the worst symptom severity over the past 24 hours. It was assessed by the participant on a daily basis from visit 1 and throughout the study, using an e-diary. It consisted of a 0 to 3 categorical scale, where 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms. Higher scores indicated more severe symptoms. The Week 24 analysis score was calculated as the average of all scores during the 4 weeks before Week 24. Baseline was defined as the average of the scores in the 7 days prior to randomization.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 Participants
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in the Severity of Decreased/Loss of Smell at Week 24
|
-0.23 score on a scale
Standard Error 0.20
|
-0.86 score on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not.
The SNOT-22 was a validated 22-items questionnaire to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL) with a recall period of 2 weeks. There were 5 domains that could be described within SNOT-22, including nasal, ear, sleep, general and practical, and emotional; each domain was scored on a 5-category scale which ranged from 0: no problem to 5: problem as bad as it can be. The total score was the sum of response to each of the 22 questions and ranged from 0 (no disease) to 110 (worst disease), higher scores indicated worse HRQoL. Baseline was defined as the last available value before randomization.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 Participants
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) at Week 24
|
-11.58 score on a scale
Standard Error 3.14
|
-21.10 score on a scale
Standard Error 3.14
|
SECONDARY outcome
Timeframe: From randomization (Day 1) up to last dose of study treatment + 14 days, a maximum of 168 daysPopulation: The ITT population included all randomized participants analyzed according to the treatment group allocated by randomization, regardless of whether the treatment kit was used or not.
SCS for rescue treatment of nasal polyps or for another reason were prescribed to the participant by the site. For participants who had a surgery or had a scheduled date for surgery for NP, the reason (worsening signs and/or symptoms during the study), the expected or actual surgery date, the type and outcome of surgery was recorded in a specific e-case report form page. Percentage of participants who received SCS or underwent NP surgery during the study treatment are presented.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 Participants
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants Who Received Systemic Corticosteroid (SCS) or Underwent Nasal Polyposis (NP) Surgery During the Study Treatment
|
9.4 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 daysPopulation: The safety population included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
An 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 untoward medical occurrence 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. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 Participants
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events Leading to Treatment Discontinuation
TEAEs
|
20 Participants
|
23 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events Leading to Treatment Discontinuation
TESAEs
|
0 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events Leading to Treatment Discontinuation
TEAEs leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Dupilumab 300 mg q2w
Serious adverse events
| Measure |
Placebo
n=32 participants at risk
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 participants at risk
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Infections and infestations
Helicobacter Gastritis
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
3.2%
1/31 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
3.2%
1/31 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
3.2%
1/31 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
3.2%
1/31 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
3.2%
1/31 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
Other adverse events
| Measure |
Placebo
n=32 participants at risk
Participants received placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks.
|
Dupilumab 300 mg q2w
n=31 participants at risk
Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks.
|
|---|---|---|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
6.5%
2/31 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
6.5%
2/31 • Number of events 3 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
3.2%
1/31 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
15.6%
5/32 • Number of events 7 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
12.9%
4/31 • Number of events 5 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.2%
2/32 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
0.00%
0/31 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
0.00%
0/31 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
6.5%
2/31 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
6.5%
2/31 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
General disorders
Influenza Like Illness
|
3.1%
1/32 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
6.5%
2/31 • Number of events 3 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
9.7%
3/31 • Number of events 3 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/32 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
6.5%
2/31 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Analysis was performed on the safety population.
|
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