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Dupilumab in Chinese Adult Participants With CRSwNP

Primary Purpose

Chronic Rhinosinusitis With Nasal Polyps

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Dupilumab
Placebo
Budesonide
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

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: 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 immunosuppressant/immunomodulator within 4 weeks before Visit 1 or 5 half-lives, whichever is longer. Any investigational monoclonal antibody (mAb) within 5 half-lives or within 6 months before Visit 1 if the half-life is unknown. Anti-immunoglobulin E therapy (omalizumab) within 4 months prior to Visit 1. Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1 Participants who are receiving leukotriene antagonists/modifiers within 4 weeks before V1 or 5 half-lives, whichever is longer, unless patient is on a continuous treatment for at least 4 weeks before Visit 1 Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy or change its dose during the run-in or randomized treatment period Participants who have undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to Visit 1 or sino-nasal surgery changing the lateral wall structure of the nose making the evaluation of NPS impossible Use of any prohibited medications and procedures during screening period or planned use during screening or study treatment period Either intravenous immunoglobulin (IVIG) therapy and/or plasmapheresis within 4 weeks before Visit 1 Current participation in any clinical trial of an investigational drug or device or participation within 3 months before V1 or 5 half-lives of the investigational compound, whichever is longer Participation in a prior dupilumab clinical study or have been treated with commercially available dupilumab Patients with any of the following result at the screening visit (Visit 1): Positive (or indeterminate) hepatitis B surface antigen (HBsAg) or, Positive total Hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or, Positive HCV Ab confirmed by positive hepatitis C Virus (HCV) RNA. noninvestigational medicinal product(NIMP) noncompliance at Visit 2 (<80%) Any condition that could make the participant noncompliant with the study procedures and daily assessment in the e-diary Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study

Sites / Locations

  • Investigational Site Number :1560005Recruiting
  • Investigational Site Number :1560001Recruiting
  • Investigational Site Number :1560010Recruiting
  • Investigational Site Number :1560014Recruiting
  • Investigational Site Number :1560022Recruiting
  • Investigational Site Number :1560012Recruiting
  • Investigational Site Number :1560011Recruiting
  • Investigational Site Number :1560004Recruiting
  • Investigational Site Number :1560006Recruiting
  • Investigational Site Number :1560016Recruiting
  • Investigational Site Number :1560025Recruiting
  • Investigational Site Number :1560013Recruiting
  • Investigational Site Number :1560017Recruiting
  • Investigational Site Number :1560018Recruiting
  • Investigational Site Number :1560007Recruiting
  • Investigational Site Number :1560021Recruiting
  • Investigational Site Number :1560009Recruiting
  • Investigational Site Number :1560020Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dupilumab

Placebo

Arm Description

Dupilumab every 2 weeks (Q2W) via SC injection

Placebo matching dupilumab Q2W via SC injection

Outcomes

Primary Outcome Measures

Change from baseline in nasal polyps score(NPS)
NPS: nasal polyps score

Secondary Outcome Measures

Change from baseline in NC score (NCS) based on the participant daily morning assessment
Change from baseline in total symptom score(TSS)
TSS: total symptom score
Change from baseline in the severity of decreased/loss of smell assessed daily by participants
Change from baseline in total score of 22-item sinonasal outcome test (SNOT-22)
Proportion of participants receiving systemic corticosteroids(SCS) for any reason or undergo surgery for nasal polyps during the study treatment
Number of participants with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to treatment discontinuation

Full Information

First Posted
May 18, 2023
Last Updated
August 28, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT05878093
Brief Title
Dupilumab in Chinese Adult Participants With CRSwNP
Official Title
A Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab, in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) on a Background Therapy With Intranasal Corticosteroids
Study Type
Interventional

2. Study Status

Record Verification Date
August 28, 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
October 2, 2024 (Anticipated)
Study Completion Date
December 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
up to 40 weeks

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dupilumab
Arm Type
Experimental
Arm Description
Dupilumab every 2 weeks (Q2W) via SC injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching dupilumab Q2W via SC injection
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Intervention Description
solution for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
solution for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
nasal spray (suspension)
Primary Outcome Measure Information:
Title
Change from baseline in nasal polyps score(NPS)
Description
NPS: nasal polyps score
Time Frame
at week 24
Secondary Outcome Measure Information:
Title
Change from baseline in NC score (NCS) based on the participant daily morning assessment
Time Frame
at Week 24
Title
Change from baseline in total symptom score(TSS)
Description
TSS: total symptom score
Time Frame
at Week 24
Title
Change from baseline in the severity of decreased/loss of smell assessed daily by participants
Time Frame
at Week 24
Title
Change from baseline in total score of 22-item sinonasal outcome test (SNOT-22)
Time Frame
at Week 24
Title
Proportion of participants receiving systemic corticosteroids(SCS) for any reason or undergo surgery for nasal polyps during the study treatment
Time Frame
Until week 24
Title
Number of participants with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to treatment discontinuation
Time Frame
Until week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 immunosuppressant/immunomodulator within 4 weeks before Visit 1 or 5 half-lives, whichever is longer. Any investigational monoclonal antibody (mAb) within 5 half-lives or within 6 months before Visit 1 if the half-life is unknown. Anti-immunoglobulin E therapy (omalizumab) within 4 months prior to Visit 1. Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1 Participants who are receiving leukotriene antagonists/modifiers within 4 weeks before V1 or 5 half-lives, whichever is longer, unless patient is on a continuous treatment for at least 4 weeks before Visit 1 Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy or change its dose during the run-in or randomized treatment period Participants who have undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to Visit 1 or sino-nasal surgery changing the lateral wall structure of the nose making the evaluation of NPS impossible Use of any prohibited medications and procedures during screening period or planned use during screening or study treatment period Either intravenous immunoglobulin (IVIG) therapy and/or plasmapheresis within 4 weeks before Visit 1 Current participation in any clinical trial of an investigational drug or device or participation within 3 months before V1 or 5 half-lives of the investigational compound, whichever is longer Participation in a prior dupilumab clinical study or have been treated with commercially available dupilumab Patients with any of the following result at the screening visit (Visit 1): Positive (or indeterminate) hepatitis B surface antigen (HBsAg) or, Positive total Hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or, Positive HCV Ab confirmed by positive hepatitis C Virus (HCV) RNA. noninvestigational medicinal product(NIMP) noncompliance at Visit 2 (<80%) Any condition that could make the participant noncompliant with the study procedures and daily assessment in the e-diary Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
8006331610
Ext
option 6
Email
contact-us@sanofi.com
Facility Information:
Facility Name
Investigational Site Number :1560005
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560001
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560010
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560014
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560022
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560012
City
Guangzhou
ZIP/Postal Code
510163
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560011
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560004
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560006
City
Hefei
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560016
City
Jinan
ZIP/Postal Code
250102
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560025
City
Jingzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560013
City
Qingdao
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560017
City
Shanghai
ZIP/Postal Code
200065
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560018
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560007
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560021
City
Wuhan
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560009
City
Yantai
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560020
City
Zibo
ZIP/Postal Code
255036
Country
China
Individual Site Status
Recruiting

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 Chinese Adult Participants With CRSwNP

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