Dupilumab in Chinese Adult Participants With CRSwNP

NCT05878093 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: EFC17026U1111-1256-9711
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

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.

  Baseline (Day 1) and Week 24

Secondary Outcomes (6)

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

  Baseline (Day -7 to Day -1) and Week 24

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

  Baseline (Day -7 to Day -1) and Week 24

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

  Baseline (Day -7 to Day -1) and Week 24

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

  Baseline (Day 1) and Week 24

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

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

Study Arms (2)

Dupilumab

EXPERIMENTAL

Dupilumab every 2 weeks (Q2W) via SC injection

Drug: Dupilumab; Drug: Budesonide

Placebo

PLACEBO COMPARATOR

Placebo matching dupilumab Q2W via SC injection

Drug: Placebo; Drug: Budesonide

Interventions

Dupilumab DRUG

solution for subcutaneous injection

Dupilumab

Placebo DRUG

solution for subcutaneous injection

Placebo

Budesonide DRUG

nasal spray (suspension)

Dupilumab; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (18)

Investigational Site Number : 1560005

Beijing, 100044, China

Location

Investigational Site Number : 1560001

Beijing, 100730, China

Location

Investigational Site Number : 1560010

Chengdu, 610041, China

Location

Investigational Site Number : 1560014

Chongqing, 400016, China

Location

Investigational Site Number : 1560022

Fuzhou, 350005, China

Location

Investigational Site Number : 1560012

Guangzhou, 510163, China

Location

Investigational Site Number : 1560011

Guangzhou, China

Location

Investigational Site Number : 1560004

Hangzhou, 310003, China

Location

Investigational Site Number : 1560006

Hefei, 230001, China

Location

Investigational Site Number : 1560016

Jinan, 250102, China

Location

Investigational Site Number : 1560025

Jingzhou, 434020, China

Location

Investigational Site Number : 1560013

Qingdao, China

Location

Investigational Site Number : 1560017

Shanghai, 200065, China

Location

Investigational Site Number : 1560018

Taiyuan, 030001, China

Location

Investigational Site Number : 1560007

Wuhan, 430022, China

Location

Investigational Site Number : 1560021

Wuhan, 430060, China

Location

Investigational Site Number : 1560009

Yantai, 264000, China

Location

Investigational Site Number : 1560020

Zibo, 255036, China

Location

Related Links

• EFC17026 Plain Language Results Summary

MeSH Terms

Interventions

dupilumab; Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610 ext 6#

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 26, 2023
• Study Start: May 16, 2023
• Primary Completion: September 6, 2024
• Study Completion: November 28, 2024
• Last Updated: September 25, 2025
• Results First Posted: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (18)