AzTrials
AzTrials

Chronic Rhinosinusitis With Nasal PolypsPhase 3NCT05878093

Dupilumab in Chinese Adult Participants With CRSwNP

A Phase 3 study testing Dupilumab and Budesonide in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Rhinosinusitis With Nasal Polyps
What is being tested?
Dupilumab and Budesonide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
18 sitesChina
Study dates
16 May 2023to 28 Nov 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 35Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Investigational Site Number : 1560005

    Beijing, 100044

  • Investigational Site Number : 1560001

    Beijing, 100730

  • Investigational Site Number : 1560010

    Chengdu, 610041

  • Investigational Site Number : 1560014

    Chongqing, 400016

  • Investigational Site Number : 1560022

    Fuzhou, 350005

  • Investigational Site Number : 1560012

    Guangzhou, 510163

  • Investigational Site Number : 1560011

    Guangzhou

  • Investigational Site Number : 1560004

    Hangzhou, 310003

  • Investigational Site Number : 1560006

    Hefei, 230001

  • Investigational Site Number : 1560016

    Jinan, 250102

  • Investigational Site Number : 1560025

    Jingzhou, 434020

  • Investigational Site Number : 1560013

    Qingdao

  • Investigational Site Number : 1560017

    Shanghai, 200065

  • Investigational Site Number : 1560018

    Taiyuan, 030001

  • Investigational Site Number : 1560007

    Wuhan, 430022

  • Investigational Site Number : 1560021

    Wuhan, 430060

  • Investigational Site Number : 1560009

    Yantai, 264000

  • Investigational Site Number : 1560020

    Zibo, 255036

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab, in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) on a Background Therapy With Intranasal Corticosteroids

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

Being tested
Dupilumab, Placebo, Budesonide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    solution for subcutaneous injection

  • PlaceboDrug

    solution for subcutaneous injection

  • BudesonideDrug

    nasal spray (suspension)

Study groups in NCT05878093
Study groupRoleWhat they receive
DupilumabExperimentalDupilumab every 2 weeks (Q2W) via SC injection
Receives: Drug: Dupilumab; Drug: Budesonide
PlaceboPlacebo comparatorPlacebo matching dupilumab Q2W via SC injection
Receives: Drug: Placebo; Drug: Budesonide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Day 1) and Week 24

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start16 May 2023
  3. Primary completion6 Sep 2024
  4. Study completion28 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05878093
Sponsor's protocol ID
EFC17026
Other IDs
U1111-1256-9711
Status last verified
Sep 2025
First submitted
18 May 2023
Last updated
25 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab and Budesonide in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Nasal Polyps Score at Week 24 (time frame: Baseline (Day 1) and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05878093, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in