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

NCT ID: NCT05049122

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-22
• Study Completion Date: 2023-07-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dupilumab

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

Group Type: EXPERIMENTAL

Dupilumab SAR231893

Intervention Type: DRUG

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

Interventions

Dupilumab SAR231893

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

Intervention Type: DRUG

Other Intervention Names

REGN668

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigational site JAPAN

Japan, , Japan

Countries

Japan

References

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 Aug 30. doi: 10.1002/lary.70037. Online ahead of print.

Reference Type: DERIVED

PMID: 40884290 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25292&tenant=MT_SNY_9011

LPS16872 Plain Language Results Summary

Other Identifiers

LPS16872

Identifier Type: -

Identifier Source: org_study_id