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Dupilumab in CRSsNP (Liberty CRSsNP)

Primary Purpose

Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis, Chronic Sinusitis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dupilumab SAR231893
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis Without Nasal Polyps

Eligibility Criteria

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

Inclusion Criteria:

  • Part A only: Participant must be at least 18 years of age at the time of signing the informed consent form (ICF).

    • Part B only: Participant must be at least 12 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the ICF.
    • Participants must have bilateral inflammation of paranasal sinuses in CT scan with LMK ≥8 and bilateral ethmoid opacification before randomization.
    • Participants must have ongoing symptoms of loss of smell and rhinorrhea (anterior/posterior) of any severity, with or without facial pain/pressure for at least 12 consecutive weeks by Visit 1.
    • Participants must have ongoing symptoms of nasal congestion (NC)/obstruction at least 12 consecutive weeks before Visit 1 and a NC score of ≥ 2 at Visit 1 (day score) and Visit 2 (weekly average score).
    • Participants must have sTSS (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score).
    • Participants must have one of the 2 following features:
  • Prior sinonasal surgery for CRS,
  • Treatment with SCS therapy for CRS as defined by any dose and duration within the prior 2 years before screening (Visit 1) or intolerance/contraindication to SCS.

    • For Part B only: participants who have a blood eosinophil count ≥300 cells/mm3 at Screening
    • Body weight ≥30 kg.

Exclusion Criteria:

  • Patients with nasal conditions/concomitant nasal diseases such as nasal polyposis in endoscopy at Visit 1 or with history of nasal polyposis etc., making them non-evaluable at Visit 1 or for the primary efficacy

    • Nasal cavity malignant tumor and benign tumors.
    • Forced expiratory volume (FEV1) ≤50% of predicted normal at Visit 1.
    • Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis.
    • Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect participation in the study
    • Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
    • Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
    • Known or suspected immunodeficiency
    • History of malignancy within 5 years before Visit 1, except completely treated in situ carcinoma of the cervix, and completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
    • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the Screening Visit 1 or during the screening period.
    • History of systemic hypersensitivity or anaphylaxis to dupilumab or any of its excipients.
    • Patients in prior dupilumab clinical trial or have been treated with commercially available dupilumab within 12 months or who discontinued dupilumab use due to adverse event.
    • Patients who are treated with intranasal corticosteroid drops; intranasal steroid emitting devices/stents; nasal spray using exhalation delivery system, such as Xhance™, during screening period.
    • Participants on unstable dose of intranasal corticosteroids (INCS) spray 4 weeks prior to Screening Visit (Visit1) and during screening period.
    • Patients who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1.
    • Patients who have taken:
  • Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 5 half-lives prior to Visit 1
  • Any investigational mAb within 5 half-lives prior to Visit 1
  • Anti-IgE therapy (omalizumab) within 4 months prior to Visit 1.

    • Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1
    • Leukotriene antagonists/modifiers unless patient is on a continuous treatment for at least 30 days prior to 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 screening or treatment period.
    • Patients received SCS during screening period (between Visit 1 and Visit 2).
    • Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to Screening Visit (Visit 1).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Sacramento Ear, Nose & Throat's-Site Number:8400010
  • Bensch Clinical Research LLC-Site Number:8400015
  • National Jewish Center-Site Number:8400008
  • Colorado Allergy and Asthma Centers, PC-Site Number:8400003
  • University of Missouri Health System-Site Number:8400016
  • Nebraska Medical Research Institute-Site Number:8400007
  • Optimed Research, LTD-Site Number:8400017
  • Vital Prospects Clinical Research Institute, P.C.-Site Number:8400004
  • Essential Medical Research, LLC-Site Number:8400014
  • Pharmaceutical Research & Consulting, Inc.-Site Number:8400006
  • North Texas Center for Clinical Research-Site Number:8400019
  • Alamo ENT Associates-Site Number:8400021
  • Eastern Virginia Medical School (EVMS) Medical Group - Otola-Site Number:8400009
  • Investigational Site Number :0320002
  • Investigational Site Number :0320003
  • Investigational Site Number :0320001
  • Investigational Site Number :0560003
  • Investigational Site Number :0560002
  • Investigational Site Number :0560001
  • Investigational Site Number :1240013
  • Investigational Site Number :1240010
  • Investigational Site Number :1240007
  • Investigational Site Number :1240016
  • Investigational Site Number :1240001
  • Investigational Site Number :1240012
  • Investigational Site Number :1240002
  • Investigational Site Number :1240005
  • Investigational Site Number :1240003
  • Investigational Site Number :1520001
  • Investigational Site Number :1560015
  • Investigational Site Number :1560009
  • Investigational Site Number :1560001
  • Investigational Site Number :1560005
  • Investigational Site Number :1560013
  • Investigational Site Number :1560012
  • Investigational Site Number :1560010
  • Investigational Site Number :1560002
  • Investigational Site Number :1560011
  • Investigational Site Number :1560006
  • Investigational Site Number :1560014
  • Investigational Site Number :1560003
  • Investigational Site Number :1560004
  • Investigational Site Number :1560008
  • Investigational Site Number :3480004
  • Investigational Site Number :3480001
  • Investigational Site Number :3480002
  • Investigational Site Number :4100001
  • Investigational Site Number :4100003
  • Investigational Site Number :4100002
  • Investigational Site Number :6200002
  • Investigational Site Number :6200001
  • Investigational Site Number :6200003
  • Investigational Site Number :6430005
  • Investigational Site Number :6430002
  • Investigational Site Number :6430003
  • Investigational Site Number :6430001
  • Investigational Site Number :7240002
  • Investigational Site Number :7240001
  • Investigational Site Number :7240007
  • Investigational Site Number :7240004
  • Investigational Site Number :7240005
  • Investigational Site Number :7240009
  • Investigational Site Number :7240008
  • Investigational Site Number :7240010
  • Investigational Site Number :7520001
  • Investigational Site Number :8040005
  • Investigational Site Number :8040001
  • Investigational Site Number :8040004
  • Investigational Site Number :8040008
  • Investigational Site Number :8040002
  • Investigational Site Number :8040007

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Part A and B: Dupilumab

Part A and B: Matching placebo

Arm Description

Dupilumab administered every 2 weeks.

Placebo administered every 2 weeks

Outcomes

Primary Outcome Measures

Change from baseline to Week 24 in opacification of sinuses assessed by CT scan using the Lund Mackay (LMK) score in the dupilumab group only
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).

Secondary Outcome Measures

Change from baseline to Week 24 in opacification of sinuses assessed by CT scan using the 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 sTSS
The sTSS is a composite score derived from the following individual items: NC, anterior/posterior rhinorrhea, and facial pain/pressure. The total score ranges from 0-9. Higher scores on sTSS indicate greater overall symptom severity.
Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), and TEAEs leading to treatment discontinuation
Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), and TEAEs leading to treatment discontinuation.
Dupilumab concentration in serum
Dupilumab concentration in serum.
Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time
Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time.

Full Information

First Posted
December 16, 2020
Last Updated
May 30, 2023
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04678856
Brief Title
Dupilumab in CRSsNP
Acronym
Liberty CRSsNP
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Uncontrolled, Chronic Rhinosinusitis Without Nasal Polyposis (CRSsNP)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

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
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
Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo Assessment of immunogenicity to dupilumab over time compared to placebo
Detailed Description
The duration of study for each participant will include 2-4 weeks of screening period, 24-52 weeks randomized investigational medicinal product (IMP) intervention period and 12 weeks of follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis, Chronic Sinusitis, Sinus Disorder, Respiratory Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A and B: Dupilumab
Arm Type
Experimental
Arm Description
Dupilumab administered every 2 weeks.
Arm Title
Part A and B: Matching placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Dupilumab SAR231893
Intervention Description
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Primary Outcome Measure Information:
Title
Change from baseline to Week 24 in opacification of sinuses assessed by CT scan using the Lund Mackay (LMK) score in the dupilumab group only
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
Secondary Outcome Measure Information:
Title
Change from baseline to Week 24 in opacification of sinuses assessed by CT scan using the 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 sTSS
Description
The sTSS is a composite score derived from the following individual items: NC, anterior/posterior rhinorrhea, and facial pain/pressure. The total score ranges from 0-9. Higher scores on sTSS indicate greater overall symptom severity.
Time Frame
Baseline to Week 24
Title
Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), and TEAEs leading to treatment discontinuation
Description
Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), and TEAEs leading to treatment discontinuation.
Time Frame
Baseline to Week 64
Title
Dupilumab concentration in serum
Description
Dupilumab concentration in serum.
Time Frame
Baseline to Week 52
Title
Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time
Description
Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time.
Time Frame
Baseline to Week 64

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 form (ICF). Participants must have bilateral inflammation of paranasal sinuses in CT scan with LMK ≥8 and bilateral ethmoid opacification before randomization. Participants must have ongoing symptoms of loss of smell and rhinorrhea (anterior/posterior) of any severity, with or without facial pain/pressure for at least 12 consecutive weeks by Visit 1. Participants must have ongoing symptoms of nasal congestion (NC)/obstruction at least 12 consecutive weeks before Visit 1 and a NC score of ≥ 2 at Visit 1 (day score) and Visit 2 (weekly average score). Participants must have sTSS (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score). Participants must have one of the 2 following features: Prior sinonasal surgery (see note at end of section 5.2 for definitions of sinonasal surgery) for CRS, Treatment with systemic corticosteroids (SCS) therapy for CRS as defined by any dose and duration within the prior 2 years before screening (Visit 1) or intolerance/contraindication to SCS. Exclusion Criteria: Patients with nasal conditions/concomitant nasal diseases such as nasal polyposis in endoscopy at Visit 1 or with history of nasal polyposis etc., making them non-evaluable at Visit 1 or for the primary efficacy Nasal cavity malignant tumor and benign tumors. Forced expiratory volume (FEV1) ≤50% of predicted normal at Visit 1. Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis. Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect participation in the study Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection Known or suspected immunodeficiency History of malignancy within 5 years before Visit 1, except completely treated in situ carcinoma of the cervix, and completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the Screening Visit 1 or during the screening period. History of systemic hypersensitivity or anaphylaxis to dupilumab or any of its excipients. Patients in prior dupilumab clinical trial or have been treated with commercially available dupilumab within 12 months or who discontinued dupilumab use due to adverse event. Patients who are treated with intranasal corticosteroid drops; intranasal steroid emitting devices/stents; nasal spray using exhalation delivery system, such as Xhance™, during screening period. Participants on unstable dose of intranasal corticosteroids (INCS) spray 4 weeks prior to Screening Visit (Visit1) and during screening period. Patients who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1. Patients who have taken: Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 5 half-lives prior to Visit 1 Any investigational mAb within 5 half-lives prior to Visit 1 Anti-IgE therapy (omalizumab) within 4 months prior to Visit 1. Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1 Leukotriene antagonists/modifiers unless patient is on a continuous treatment for at least 30 days prior to 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 screening or treatment period. Patients received SCS during screening period (between Visit 1 and Visit 2). Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to Screening Visit (Visit 1). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sacramento Ear, Nose & Throat's-Site Number:8400010
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Bensch Clinical Research LLC-Site Number:8400015
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
National Jewish Center-Site Number:8400008
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Colorado Allergy and Asthma Centers, PC-Site Number:8400003
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
University of Missouri Health System-Site Number:8400016
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Nebraska Medical Research Institute-Site Number:8400007
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Optimed Research, LTD-Site Number:8400017
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C.-Site Number:8400004
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Essential Medical Research, LLC-Site Number:8400014
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Facility Name
Pharmaceutical Research & Consulting, Inc.-Site Number:8400006
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
North Texas Center for Clinical Research-Site Number:8400019
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Alamo ENT Associates-Site Number:8400021
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Eastern Virginia Medical School (EVMS) Medical Group - Otola-Site Number:8400009
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Investigational Site Number :0320002
City
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Investigational Site Number :0320003
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Facility Name
Investigational Site Number :0320001
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
Investigational Site Number :0560003
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Investigational Site Number :0560002
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigational Site Number :0560001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site Number :1240013
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Investigational Site Number :1240010
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Investigational Site Number :1240007
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Investigational Site Number :1240016
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Investigational Site Number :1240001
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Investigational Site Number :1240012
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Investigational Site Number :1240002
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Investigational Site Number :1240005
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Investigational Site Number :1240003
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Investigational Site Number :1520001
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Investigational Site Number :1560015
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Investigational Site Number :1560009
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Investigational Site Number :1560001
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Investigational Site Number :1560005
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Investigational Site Number :1560013
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Investigational Site Number :1560012
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Investigational Site Number :1560010
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Investigational Site Number :1560002
City
Hangzhou Shi
ZIP/Postal Code
310003
Country
China
Facility Name
Investigational Site Number :1560011
City
Qingdao
ZIP/Postal Code
266555
Country
China
Facility Name
Investigational Site Number :1560006
City
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Investigational Site Number :1560014
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Investigational Site Number :1560003
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Investigational Site Number :1560004
City
Xi'an
ZIP/Postal Code
710004
Country
China
Facility Name
Investigational Site Number :1560008
City
Yantai
ZIP/Postal Code
264000
Country
China
Facility Name
Investigational Site Number :3480004
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Investigational Site Number :3480001
City
Pécs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Investigational Site Number :3480002
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Investigational Site Number :4100001
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100003
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100002
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Investigational Site Number :6200002
City
Aveiro
ZIP/Postal Code
3810-501
Country
Portugal
Facility Name
Investigational Site Number :6200001
City
Guimarães
ZIP/Postal Code
4810-061
Country
Portugal
Facility Name
Investigational Site Number :6200003
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Investigational Site Number :6430005
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Investigational Site Number :6430002
City
St-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigational Site Number :6430003
City
St-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
Stavropol
ZIP/Postal Code
355020
Country
Russian Federation
Facility Name
Investigational Site Number :7240002
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number :7240007
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Investigational Site Number :7240005
City
Madrid / Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number :7240009
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28027
Country
Spain
Facility Name
Investigational Site Number :7240008
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Investigational Site Number :7240010
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Investigational Site Number :7520001
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Investigational Site Number :8040005
City
Dnipro
ZIP/Postal Code
49006
Country
Ukraine
Facility Name
Investigational Site Number :8040001
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigational Site Number :8040004
City
Kharkiv
ZIP/Postal Code
61166
Country
Ukraine
Facility Name
Investigational Site Number :8040008
City
Kyiv
ZIP/Postal Code
01033
Country
Ukraine
Facility Name
Investigational Site Number :8040002
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Investigational Site Number :8040007
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine

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 CRSsNP

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