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CompletedNCT05878093Updated Sep 25, 2025Results posted

Dupilumab in Chinese Adult Participants With CRSwNP

A Phase 3 interventional study of Dupilumab and Placebo in Chronic Rhinosinusitis With Nasal Polyps, sponsored by Sanofi. Completed at 18 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a parallel group, Phase 3, 2-arm study for treatment. The purpose of this study is to evaluate dupilumab subcutaneous (SC) injections compared to placebo in Chinese adult participants with CRSwNP, on a background therapy with intranasal corticosteroids (budesonide nasal spray).

Study details include:

  • The study duration will be up to 40 weeks.
  • The treatment duration will be up to 24 weeks.
  • The number of visits will be 7.
Read the detailed description

up to 40 weeks

02

Conditions studied

  • Chronic Rhinosinusitis With Nasal Polyps
03

In context

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Browse Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant must be at least 18 years of age at the time of signing the informed consent

  • Participants with bilateral sino-nasal polyposis that despite prior treatment with SCS anytime within the past 2 years; and/or who have a medical contraindication/intolerance to SCS; and/or had prior surgery for NP at Visit 1 have:

    1. An endoscopic bilateral NPS at Visit 1 of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) as per central assessment

    2. Ongoing symptoms (for at least 8 weeks before Visit 1) of:

      • Nasal congestion/blockade/obstruction with moderate or severe symptom severity (Score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 at time of randomization (Visit 2) AND
      • Another symptom such as loss of smell, rhinorrhea (anterior/posterior)

Note: Plan to enroll at least 85% (approximately 52) participants with CRSwNP meeting following criterion:

  • Participants with peripheral blood eosinophil count ≥300/mm3
  • Contraceptive use should be consistent with the regulations regarding the methods of contraception for those participating in clinical studies
  • Capable of giving signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint (ie, NPS)
  • Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, hemangioma, etc)
  • Participant with historical spirometry results which showed 50% or less of predicted normal of forced expiratory volume in one second (FEV1)
  • Diagnosed with; suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before Visit 1 or during the screening period
  • History of human immunodeficiency virus infection or positive HIV 1/2 serology at Visit 1
  • Known or suspected immunodeficiency
  • Participants with active Tuberculosis (TB), non-tuberculous mycobacterial infection or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before Visit 1 or during the screening period
  • Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
  • Known or suspected alcohol and/or drug abuse
  • History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient
  • Participants meet any contraindications or warning on product labeling for budesonide nasal spray
  • Severe concomitant illness(es) that, in the Investigator's judgement, would adversely affect the participant's participation in the study.
  • Participants with any other medical or psychological condition including relevant laboratory or electrocardiogram (ECG) abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may make participant's participation unreliable, or may interfere with study assessments. The specific justification for participants excluded under this criterion will be noted in study documents (chart notes, case report form (CRF), etc)
  • Planned major surgical procedure during the participant's participation in this study
  • Participants who have taken:

Biologic therapy/systemic immunosuppressant/immunomodulator within 4 weeks before Visit 1 or 5 half-lives, whichever is longer.

Any investigational monoclonal antibody (mAb) within 5 half-lives or within 6 months before Visit 1 if the half-life is unknown.

Anti-immunoglobulin E therapy (omalizumab) within 4 months prior to Visit 1.

  • Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1
  • Participants who are receiving leukotriene antagonists/modifiers within 4 weeks before V1 or 5 half-lives, whichever is longer, unless patient is on a continuous treatment for at least 4 weeks before Visit 1
  • Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy or change its dose during the run-in or randomized treatment period
  • Participants who have undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to Visit 1 or sino-nasal surgery changing the lateral wall structure of the nose making the evaluation of NPS impossible
  • Use of any prohibited medications and procedures during screening period or planned use during screening or study treatment period
  • Either intravenous immunoglobulin (IVIG) therapy and/or plasmapheresis within 4 weeks before Visit 1
  • Current participation in any clinical trial of an investigational drug or device or participation within 3 months before V1 or 5 half-lives of the investigational compound, whichever is longer
  • Participation in a prior dupilumab clinical study or have been treated with commercially available dupilumab
  • Patients with any of the following result at the screening visit (Visit 1):

Positive (or indeterminate) hepatitis B surface antigen (HBsAg) or, Positive total Hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or, Positive HCV Ab confirmed by positive hepatitis C Virus (HCV) RNA.

  • noninvestigational medicinal product(NIMP) noncompliance at Visit 2 (\<80%)
  • Any condition that could make the participant noncompliant with the study procedures and daily assessment in the e-diary
  • Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
  • Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
  • Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Dupilumab

    Dupilumab every 2 weeks (Q2W) via SC injection

    Drug: Dupilumab · Drug: Budesonide

  • Placebo comparator
    Placebo

    Placebo matching dupilumab Q2W via SC injection

    Drug: Placebo · Drug: Budesonide

Interventions

  • DrugDupilumab

    solution for subcutaneous injection

  • DrugPlacebo

    solution for subcutaneous injection

  • DrugBudesonide

    nasal spray (suspension)

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Nasal Polyps Score at Week 24

    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.

    Time frame: Baseline (Day 1) and Week 24

Secondary outcomes

  1. Change From Baseline in Nasal Congestion/Obstruction Score (NCS) at Week 24

    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.

    Time frame: Baseline (Day -7 to Day -1) and Week 24

  2. Change From Baseline in Total Symptoms Score (TSS) at Week 24

    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.

    Time frame: Baseline (Day -7 to Day -1) and Week 24

  3. Change From Baseline in the Severity of Decreased/Loss of Smell at Week 24

    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.

    Time frame: Baseline (Day -7 to Day -1) and Week 24

  4. Change From Baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) at Week 24

    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.

    Time frame: Baseline (Day 1) and Week 24

  5. Percentage of Participants Who Received Systemic Corticosteroid (SCS) or Underwent Nasal Polyposis (NP) Surgery During the Study Treatment

    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.

    Time frame: From randomization (Day 1) up to last dose of study treatment + 14 days, a maximum of 168 days

  6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events Leading to Treatment Discontinuation

    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.

    Time frame: From first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days

07

Results

Posted Sep 25, 2025

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.

Participant flow — Overall Study
MilestonePlaceboDupilumab 300 mg q2w
Started3231
Completed2930
Not completed31
Withdrew: Withdrawal by subject31

Outcome measures

PrimaryChange From Baseline in Nasal Polyps Score at Week 24

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.

Time frame:
Baseline (Day 1) and Week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in Nasal Polyps Score at Week 24
score on a scalePlaceboDupilumab 300 mg q2w
Change From Baseline in Nasal Polyps Score at Week 24-0.50 ± 0.30-2.34 ± 0.30
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = <0.0001 · Least square mean difference: -1.84 · 95% CI -2.53 to -1.15Data was analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.
SecondaryChange From Baseline in Nasal Congestion/Obstruction Score (NCS) at Week 24

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.

Time frame:
Baseline (Day -7 to Day -1) and Week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in Nasal Congestion/Obstruction Score (NCS) at Week 24
score on a scalePlaceboDupilumab 300 mg q2w
Change From Baseline in Nasal Congestion/Obstruction Score (NCS) at Week 24-0.52 ± 0.18-1.06 ± 0.18
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = 0.0126 · Least square mean difference: -0.54 · 95% CI -0.97 to -0.12Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.
SecondaryChange From Baseline in Total Symptoms Score (TSS) at Week 24

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.

Time frame:
Baseline (Day -7 to Day -1) and Week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in Total Symptoms Score (TSS) at Week 24
score on a scalePlaceboDupilumab 300 mg q2w
Change From Baseline in Total Symptoms Score (TSS) at Week 24-1.07 ± 0.43-2.75 ± 0.43
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = 0.0008 · Least square mean difference: -1.68 · 95% CI -2.67 to -0.69Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.
SecondaryChange From Baseline in the Severity of Decreased/Loss of Smell at Week 24

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.

Time frame:
Baseline (Day -7 to Day -1) and Week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Severity of Decreased/Loss of Smell at Week 24
score on a scalePlaceboDupilumab 300 mg q2w
Change From Baseline in the Severity of Decreased/Loss of Smell at Week 24-0.23 ± 0.20-0.86 ± 0.20
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = 0.0072 · Least square mean difference: -0.62 · 95% CI -1.08 to -0.17Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.
SecondaryChange From Baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) at Week 24

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.

Time frame:
Baseline (Day 1) and Week 24
Reported as:
Least squares mean · score on a scale
Change From Baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) at Week 24
score on a scalePlaceboDupilumab 300 mg q2w
Change From Baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) at Week 24-11.58 ± 3.14-21.10 ± 3.14
Statistical analysis
  • Placebo vs Dupilumab 300 mg q2w · ANCOVA · p = 0.0104 · Least square mean difference: -9.52 · 95% CI -16.81 to -2.24Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.
SecondaryPercentage of Participants Who Received Systemic Corticosteroid (SCS) or Underwent Nasal Polyposis (NP) Surgery During the Study Treatment

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.

Time frame:
From randomization (Day 1) up to last dose of study treatment + 14 days, a maximum of 168 days
Reported as:
Number · percentage of participants
Percentage of Participants Who Received Systemic Corticosteroid (SCS) or Underwent Nasal Polyposis (NP) Surgery During the Study Treatment
percentage of participantsPlaceboDupilumab 300 mg q2w
Percentage of Participants Who Received Systemic Corticosteroid (SCS) or Underwent Nasal Polyposis (NP) Surgery During the Study Treatment9.40
SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events Leading to Treatment Discontinuation

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.

Time frame:
From first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Reported as:
Count of participants · 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
ParticipantsPlaceboDupilumab 300 mg q2w
TEAEs2023
TESAEs04
TEAEs leading to treatment discontinuation00

Adverse events

Collected over 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. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/32 (0%)0/32 (0%)11/32 (34.4%)
Dupilumab 300 mg q2w0/31 (0%)4/31 (12.9%)15/31 (48.4%)
Most frequent serious events
Most frequent serious events
EventPlaceboDupilumab 300 mg q2w
Helicobacter GastritisInfections and infestations0/321/31
Endometrial CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/321/31
SyncopeNervous system disorders0/321/31
Angina PectorisCardiac disorders0/321/31
AsthmaRespiratory, thoracic and mediastinal disorders0/321/31
Most frequent other events
Showing 10 of 11
Most frequent other events
EventPlaceboDupilumab 300 mg q2w
Upper Respiratory Tract InfectionInfections and infestations5/324/31
Injection Site ReactionGeneral disorders0/323/31
ConjunctivitisInfections and infestations0/322/31
NasopharyngitisInfections and infestations2/322/31
Hepatic SteatosisHepatobiliary disorders0/322/31
ArthralgiaMusculoskeletal and connective tissue disorders0/322/31
Influenza Like IllnessGeneral disorders1/322/31
Alanine Aminotransferase IncreasedInvestigations0/322/31
PneumoniaInfections and infestations2/321/31
AsthmaRespiratory, thoracic and mediastinal disorders2/320/31

Baseline characteristics

The randomized population included all participants with a treatment kit number allocated and recorded in the interactive response technology database, regardless of whether the treatment kit was used or not.

Age, Continuous
Age, Continuous(years)PlaceboDupilumab 300 mg q2wTotal
Mean49.4 ± 11.347.1 ± 12.148.3 ± 11.6
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboDupilumab 300 mg q2wTotal
Female131427
Male191736
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboDupilumab 300 mg q2wTotal
Asian323163
Nasal Polyps Score (NPS)
Nasal Polyps Score (NPS)(score on a scale)PlaceboDupilumab 300 mg q2wTotal
Mean5.84 ± 1.605.53 ± 1.415.69 ± 1.51
08

Study locations

18 sites
  • Investigational Site Number : 1560005
    Beijing, 100044, China
  • Investigational Site Number : 1560001
    Beijing, 100730, China
  • Investigational Site Number : 1560010
    Chengdu, 610041, China
  • Investigational Site Number : 1560014
    Chongqing, 400016, China
  • Investigational Site Number : 1560022
    Fuzhou, 350005, China
  • Investigational Site Number : 1560012
    Guangzhou, 510163, China
  • Investigational Site Number : 1560011
    Guangzhou, China
  • Investigational Site Number : 1560004
    Hangzhou, 310003, China
  • Investigational Site Number : 1560006
    Hefei, 230001, China
  • Investigational Site Number : 1560016
    Jinan, 250102, China
  • Investigational Site Number : 1560025
    Jingzhou, 434020, China
  • Investigational Site Number : 1560013
    Qingdao, China
  • Investigational Site Number : 1560017
    Shanghai, 200065, China
  • Investigational Site Number : 1560018
    Taiyuan, 030001, China
  • Investigational Site Number : 1560007
    Wuhan, 430022, China
  • Investigational Site Number : 1560021
    Wuhan, 430060, China
  • Investigational Site Number : 1560009
    Yantai, 264000, China
  • Investigational Site Number : 1560020
    Zibo, 255036, China
09

References and documents

Publications

  • Xian M, Wang M, Zhao C, Wan L, Xu Y, Meng J, Xu R, Song X, Shi L, Yang Y, Jiang Y, Wu Y, Ling B, Li V, Fontenot AP, Robinson LR, Phadke NA, Wang C, Zhang L. Efficacy and Safety of Dupilumab in Chinese Adult Patients With Chronic Rhinosinusitis With Nasal Polyps: A Randomized, Placebo-Controlled, Phase III Trial. Allergy. 2026 Jun 16. doi: 10.1111/all.70414. Online ahead of print. PubMed 42299713 ↗

Study documents

  • Study protocol · Sep 14, 2022
  • Statistical analysis plan · Aug 1, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05878093
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
May 26, 2023
Start date
May 16, 2023
Primary completion
Sep 6, 2024
Completion
Nov 28, 2024
Results posted
Sep 25, 2025
Last update
Sep 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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