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

Primary Purpose

Chronic Rhinosinusitis With Nasal Polyps

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Dupilumab SAR231893

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational site JAPAN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dupilumab

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of participants with nasal polyp score (NPS) improvement from baseline ≥1 at Week 24

NPS is the sum of the right and left nostrils, ranging from 0 (no polyps) to 8 (large polyps causing complete obstruction).

Secondary Outcome Measures

Change from baseline to Week 24 in bilateral NPS

NPS is the sum of the right and left nostrils, ranging from 0 (no polyps) to 8 (large polyps causing complete obstruction).

Change from baseline to Week 24 in in nasal congestion/obstruction (NC) symptom severity score using the CRSwNP nasal symptom diary

The nasal congestion/obstruction scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').

Change from baseline to Week 24 in opacification of sinuses assessed by computerized tomography (CT) scan using the Lund Mackay (LMK) score

LMK total score is based on assessment of the CT scan findings for each sinus area. The extent of opacification is rated between 0 (normal) to 24 (total opacification).

Change from baseline to Week 24 in total symptom score (TSS)

The total symptom score (TSS) is a composite score (ranging between 0 and 9) consisting of the sum of the following symptoms assessed daily in the morning: nasal congestion/obstruction, decreased/loss of sense of smell, rhinorrhea (average of anterior/posterior nasal discharge).

Change from baseline to Week 24 in loss of smell symptom severity score using the nasal symptom diary

The loss of sense of smell symptom severity scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms')

Change from baseline to Week 24 in visual analogue scale (VAS) for rhinosinusitis

The VAS for rhinosinusitis ranges from 0 to 10 cm. Mild = VAS 0-3; Moderate = VAS >3 to 7; Severe = VAS >7 to 10.

Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to treatment discontinuation

Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to treatment discontinuation.

Full Information

NCT ID

NCT05049122

First Posted

September 14, 2021

Last Updated

August 11, 2023

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05049122

Brief Title

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

Official Title

A Single-arm, 52 Weeks, Phase 4 Study to Assess the Efficacy and Safety of Dupilumab in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Who Are Not Adequately Controlled With Existing Therapies

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

October 22, 2021 (Actual)

Primary Completion Date

December 21, 2022 (Actual)

Study Completion Date

July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Rhinosinusitis With Nasal Polyps

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dupilumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dupilumab SAR231893

Other Intervention Name(s)

REGN668

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of participants with nasal polyp score (NPS) improvement from baseline ≥1 at Week 24

Description

NPS is the sum of the right and left nostrils, ranging from 0 (no polyps) to 8 (large polyps causing complete obstruction).

Time Frame

Baseline to Week 24

Secondary Outcome Measure Information:

Title

Change from baseline to Week 24 in bilateral NPS

Description

NPS is the sum of the right and left nostrils, ranging from 0 (no polyps) to 8 (large polyps causing complete obstruction).

Time Frame

Baseline to Week 24

Title

Change from baseline to Week 24 in in nasal congestion/obstruction (NC) symptom severity score using the CRSwNP nasal symptom diary

Description

The nasal congestion/obstruction scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').

Time Frame

Baseline to Week 24

Title

Change from baseline to Week 24 in opacification of sinuses assessed by computerized tomography (CT) scan using the Lund Mackay (LMK) score

Description

LMK total score is based on assessment of the CT scan findings for each sinus area. The extent of opacification is rated between 0 (normal) to 24 (total opacification).

Time Frame

Baseline to Week 24

Title

Change from baseline to Week 24 in total symptom score (TSS)

Description

Time Frame

Baseline to Week 24

Title

Change from baseline to Week 24 in loss of smell symptom severity score using the nasal symptom diary

Description

The loss of sense of smell symptom severity scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms')

Time Frame

Baseline to Week 24

Title

Change from baseline to Week 24 in visual analogue scale (VAS) for rhinosinusitis

Description

The VAS for rhinosinusitis ranges from 0 to 10 cm. Mild = VAS 0-3; Moderate = VAS >3 to 7; Severe = VAS >7 to 10.

Time Frame

Baseline to Week 24

Title

Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to treatment discontinuation

Description

Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to treatment discontinuation.

Time Frame

Baseline to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Investigational site JAPAN

City

Japan

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

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

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