Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)

NCT05049122 | Completed Phase 4 Results FDA Drug

• 1 other identifier: LPS16872
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately controlled with existing therapies. Duration of study period (per participant):

• Screening Period (2 to 4 weeks)
• Intervention Period (up to 52 weeks±3 days)

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With NPS Improvement From Baseline >=1 at Week 24

  The NPS was the sum of right and left nostril scores as assessed by central video recordings of nasal endoscopy (NE). For each nostril, NPS was graded based on polyp size: Grade 0:No polyps; Grade 1:Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; Grade 2:Polyps reaching below the lower border of the middle turbinate; Grade 3:Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; Grade 4:Large polyps causing complete obstruction of the inferior nasal cavity. Score ranged from 0-8; higher scores indicated more severity. The baseline value was defined as the last available value before first study treatment administration.

  Baseline (Day 1) and Week 24

Secondary Outcomes (7)

• Change From Baseline in Bilateral NPS at Week 24

  Baseline (Day 1) and Week 24

• Change From Baseline in Nasal Congestion/Obstruction (NC) Symptom Severity Score Using the CRSwNP Nasal Symptom Diary at Week 24

  Baseline (Day 1) and Week 24

• Change From Baseline in Opacification of Sinuses Assessed by Computerized Tomography (CT) Scan Using the Lund Mackay (LMK) Score at Week 24

  Baseline (Day 1) and Week 24

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

  Baseline (Day 1) and Week 24

• Change From Baseline in Loss of Smell Symptom Severity Score Using the Nasal Symptom Diary at Week 24

  Baseline (Day 1) and Week 24

Study Arms (1)

Dupilumab

EXPERIMENTAL

Dupilumab every 2 weeks (q2w). Dosing interval may be changed from q2w to q4w at week 24

Drug: Dupilumab SAR231893

Interventions

Dupilumab SAR231893 DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Also known as: REGN668

Dupilumab

Eligibility Criteria

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

You may qualify if:

• Participants ≧18 years of age.
• Participants with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or had a medical contraindication / intolerance to SCS; and/or had prior surgery for NP at the screening visit, had:
• An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
• Ongoing symptoms (for at least 8 weeks prior to Visit \[V\] 1) of nasal congestion/blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at the time of enrollment (V2), and loss of smell, rhinorrhea (anterior/posterior).
• Participant's body weight \> 30 kg at V1.
• Signed written informed consent.

You may not qualify if:

• Participant with conditions/concomitant diseases making them non evaluable at V1 or for the primary efficacy endpoint such as: Antrochoanal polyps; Nasal septal deviation that would occlude at least one nostril; Acute sinusitis, nasal infection or upper respiratory infection; Ongoing rhinitis medicamentosa; Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis; Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis;
• Participant with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc).
• Participant diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before V1 or during screening
• Undergone any and/or sinus intranasal surgery within 6 months before V1.
• Participant who had participated in prior dupilumab clinical study or had been treated with commercially available dupilumab
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Investigational site JAPAN

Japan, Japan

Location

Related Publications (1)

• Fujieda S, Takabayashi T, Ohta N, Yoshikawa M, Kibe Y, Ishida M, Suzuki K, Takahashi Y, Amin N, Wright L, Robinson L, Yahata K. Effectiveness and Safety of Dupilumab Monotherapy in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyps. Laryngoscope. 2025 Dec;135(12):4625-4632. doi: 10.1002/lary.70037. Epub 2025 Aug 30.

  PMID: 40884290 DERIVED

Related Links

• LPS16872 Plain Language Results Summary

MeSH Terms

Interventions

dupilumab

Results Point of Contact

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

Contact-US@sanofi.com

800-633-1610

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 17, 2021
• Study Start: October 22, 2021
• Primary Completion: December 21, 2022
• Study Completion: July 5, 2023
• Last Updated: September 11, 2025
• Results First Posted: January 22, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)