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Phase 3 N=63 Randomized Quadruple-blind Treatment

Dupilumab in Chinese Adult Participants With CRSwNP

Chronic Rhinosinusitis With Nasal Polyps

Enrolled (actual)
63
Serious AEs
6.4%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline in Nasal Polyps Score at Week 24 — -0.50; -2.34 score on a scale — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Dupilumab (Drug); Placebo (Drug); Budesonide (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Sanofi
Primary completion
Sep 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Nasal Polyps Score at Week 24
-0.50; -2.34 <0.0001 sig
SECONDARY
Change From Baseline in Nasal Congestion/Obstruction Score (NCS) at Week 24
-0.52; -1.06 0.0126 sig
SECONDARY
Change From Baseline in Total Symptoms Score (TSS) at Week 24
-1.07; -2.75 0.0008 sig
SECONDARY
Change From Baseline in the Severity of Decreased/Loss of Smell at Week 24
-0.23; -0.86 0.0072 sig
SECONDARY
Change From Baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) at Week 24
-11.58; -21.10 0.0104 sig
SECONDARY
Percentage of Participants Who Received Systemic Corticosteroid (SCS) or Underwent Nasal Polyposis (NP) Surgery During the Study Treatment
9.4; 0
SECONDARY
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events Leading to Treatment Discontinuation
20; 23; 0; 4; 0; 0

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.

Eligibility Criteria

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:
  • 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)

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

  • 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 immuno

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05878093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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