Dupilumab in CRSsNP (Liberty CRSsNP ORION)

• ClinicalTrials.gov Identifier: NCT04678856
• Recruitment Status: Recruiting
• First Posted: December 22, 2020
• Last Update Posted: February 28, 2023
• Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Sanofi

Study Description

Brief Summary:

Primary Objective:

Part A and B: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan and sinus total symptom score (sTSS) compared to placebo

Secondary Objectives:

Part A

• To evaluate the efficacy of dupilumab as assessed by the reduction at Week 52 in sinus opacification on CT scan and total symptom score (sTSS) compared to placebo
• To evaluate the efficacy of dupilumab in improving CRSsNP symptoms at Weeks 24 and 52 compared to placebo
• To evaluate the effect of dupilumab on health related quality of life at Weeks 24 and 52 (HRQoL) compared to placebo
• To evaluate the effect of dupilumab on CRSsNP overall disease severity at Weeks 24 and 52 compared to placebo
• To evaluate the effect of dupilumab at Weeks 24 and 52 in the subgroups of participants with comorbid asthma compared to placebo
• To evaluate the ability of dupilumab to reduce the incidence of participants with CRSsNP worsening/acute sinusitis who require treatment with antibiotics, systemic corticosteroids (SCS) or sinus surgery compared to placebo
• To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP and type 2 inflammation
• To evaluate the effect of dupilumab in the subgroup of participants with screening blood eosinophils count ≥300 cells/mm3 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

Part B

• To evaluate the efficacy of dupilumab in improving CRSsNP symptoms at Week 24 compared to placebo in patients
• To evaluate the effect of dupilumab on health related quality of life (HRQoL) compared to placebo
• To evaluate the effect of dupilumab on CRSsNP overall disease severity compared to placebo
• To evaluate the effect of dupilumab in the subgroups of participants with comorbid asthma compared to placebo
• To evaluate the ability of dupilumab to reduce the incidence of participants with CRSsNP worsening/acute sinusitis who require treatment with antibiotics, SCS, or sinus surgery compared to placebo
• To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP and type 2 inflammation
• 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

Condition or disease	Intervention/treatment	Phase
Chronicrhinosinusitis Without Nasalpolyps; Sinusitis; Chronic Sinusitis; Sinus Disorder; Respiratory Disorder	Drug: Dupilumab SAR231893; Drug: Placebo	Phase 3

Detailed Description:

The duration of study for each participant will include 2-4 weeks of screening period, randomized investigational medicinal product (IMP) intervention period (52 weeks in Part A and 24 weeks in Part B) and 12 weeks of follow-up period.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Uncontrolled, Chronic Rhinosinusitis Without Nasal Polyposis (CRSsNP)
• Actual Study Start Date: December 2, 2020
• Estimated Primary Completion Date: July 31, 2023
• Estimated Study Completion Date: May 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Part A and B: Dupilumab; Dupilumab administered every 2 weeks.	Drug: Dupilumab SAR231893; Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Placebo Comparator: Part A and B: Matching placebo; Placebo administered every 2 weeks	Drug: Placebo; Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Outcome Measures

Primary Outcome Measures :

1. Part A and B: Change from baseline to Week 24 in opacification of sinuses assessed by CT scan using the Lund Mackay (LMK) score [ Time Frame: Baseline to Week 24 ]
   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).
2. Part A and B: Change from baseline to Week 24 in sTSS [ Time Frame: Baseline to Week 24 ]
   The sinus Total Symptom Score (sTSS) is a composite score derived from the following individual items: nasal congestion (NC), anterior/posterior rhinorrhea, and facial pain/pressure. The total score ranges from 0-9. Higher scores on sTSS indicate greater overall symptom severity.

Secondary Outcome Measures :

1. Part A: Change from baseline to Week 52 in opacification of sinuses assessed by CT scan using the LMK score [ Time Frame: Baseline to Week 52 ]
   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).
2. Part A: Change from baseline to Week 52 in sTSS [ Time Frame: Baseline to Week 52 ]
   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.
3. Part A and B: Change from baseline in NC symptom severity score [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
   NC symptom severity scores are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living").
4. Part A and B: Change from baseline in anterior/posterior rhinorrhea severity score [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
   Anterior/posterior rhinorrhea severity scores are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living").
5. Part A and B: Change from baseline in facial pain/pressure severity score [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
   Facial pain/pressure severity scores are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living").
6. Part A and B: Change from baseline in loss of smell symptom severity score [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
   Loss of smell symptom severity scores are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living").
7. Part A and B: Change from baseline in University of Pennsylvania smell identification test (UPSIT) [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
   The UPSIT score ranges from 0 to 40, with 40 being the best possible score.
8. Part A and B: Change from baseline in Sino-Nasal Outcome Test-22 item (SNOT-22) [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
   SNOT-22 is a patient-reported outcome (PRO) questionnaire. Score ranges from 0 to 110 with higher score indicating greater rhinosinusitis related health burden.
9. Part A and B: Change from baseline in rhinosinusitis severity visual analog scale (VAS) [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
   VAS score ranges from 0 ('not troublesome') to 10 ('worst thinkable troublesome').
10. Part A and B: Change from baseline in forced expiratory volume (FEV1) in CRSsNP with asthma population [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
    Change from baseline in forced expiratory volume (FEV1) in CRSsNP with asthma population.
11. Part A and B: Change from baseline in asthma control questionnaire 6 items (ACQ-6) in CRSsNP with asthma population [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
    The asthma control questionnaire 6-items (ACQ-6) was designed to measure both the adequacy of asthma control and the change in asthma control. ACQ-6 global score ranges from 0 (totally controlled) to 6 (severely uncontrolled). A higher score indicates lower asthma control.
12. Part A and B: Change from baseline in opacification of sinuses assessed by CT scan using the LMK score in CRSsNP with asthma population [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
    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).
13. Part A and B: Change from baseline in sTSS in CRSsNP with asthma population [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
    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.
14. Part A and B: Proportion of participants with CRSsNP worsening/acute sinusitis during the planned study treatment period [ Time Frame: Part A: Baseline to Week 52 Part B: Baseline to Week 24 ]
    CRSsNP worsening/acute sinusitis is defined as worsening of any CRS symptoms that requires initiation of rescue therapy.
15. Part A and B: Annualized rate of SCS course during the planned study treatment period [ Time Frame: Part A: Baseline to Week 52 Part B: Baseline to Week 24 ]
    A course of SCS is considered continuous if treatment is separated by less than 7 days.
16. Part A and B: Normalized Enrichment Score (NES) for the relative change from baseline in the type 2 inflammation transcriptome signature [ Time Frame: Part A: Baseline to Week 24 and 52 Part B: Baseline to Week 24 ]
    Normalized Enrichment Score (NES) reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set.
17. Part A: Change from baseline to Weeks 24 and 52 in opacification of sinuses assessed by CT scan using LMK score in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    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).
18. Part A: Change from baseline to Weeks 24 and 52 in sTSS in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]

    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.

19. Part A: Change from baseline in NC symptom severity score in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    NC symptom severity scores are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living").
20. Part A: Change from baseline in anterior/posterior rhinorrhea severity score in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    Anterior/posterior rhinorrhea severity scores are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living").
21. Part A: Change from baseline in facial pain/pressure severity score in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    Facial pain/pressure severity scores are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living").
22. Part A: Change from baseline in loss of smell symptom severity score in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    Loss of smell symptom severity scores are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living").
23. Part A: Change from baseline in UPSIT in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    The UPSIT score ranges from 0 to 40, with 40 being the best possible score.
24. Part A: Change from baseline in SNOT-22 in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    SNOT-22 is a patient-reported outcome (PRO) questionnaire. Score ranges from 0 to 110 with higher score indicating greater rhinosinusitis related health burden.
25. Part A: Change from baseline in rhinosinusitis severity VAS in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    VAS score ranges from 0 ('not troublesome') to 10 ('worst thinkable troublesome').
26. Part A: Proportion of participants with CRSsNP worsening/acute sinusitis during the planned study treatment period in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    CRSsNP worsening/acute sinusitis is defined as worsening of any CRS symptoms that requires initiation of rescue therapy.
27. Part A: Annualized rate of SCS course during the planned study treatment period in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    A course of SCS is considered continuous if treatment is separated by less than 7 days.
28. Part A: NES for the relative change from baseline in the type 2 inflammation transcriptome signature in the screening blood eosinophil count ≥300 cells/mm3 population [ Time Frame: Baseline to Week 24 and 52 ]
    Normalized Enrichment Score (NES) reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set.
29. Part A and B: Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), and TEAEs leading to treatment discontinuation [ Time Frame: Part A: Baseline to Week 64 Part B: Baseline to Week 36 ]
    Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), and TEAEs leading to treatment discontinuation.
30. Part A and B: Dupilumab concentration in serum [ Time Frame: Part A: Baseline to Week 52 Part B: Baseline to Week 24 ]
    Dupilumab concentration in serum.
31. Part A and B: Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time [ Time Frame: Part A: Baseline to Week 64 Part B: Baseline to Week 36 ]
    Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Trial Transparency email recommended (Toll free number for US & Canada); 800-633-1610 ext option 6; Contact-US@sanofi.com

Locations

United States, California

Sacramento Ear, Nose & Throat's-Site Number:8400010; Recruiting

Roseville, California, United States, 95661

Bensch Clinical Research LLC-Site Number:8400015; Recruiting

Stockton, California, United States, 95207

United States, Colorado

National Jewish Center-Site Number:8400008; Recruiting

Denver, Colorado, United States, 80206

Colorado Allergy and Asthma Centers, PC-Site Number:8400003; Completed

Denver, Colorado, United States, 80230

United States, Florida

AdtreMed-Site Number:8400018; Recruiting

Tampa, Florida, United States, 33607

United States, Missouri

University of Missouri Health System-Site Number:8400016; Recruiting

Columbia, Missouri, United States, 65212

United States, Nebraska

Nebraska Medical Research Institute-Site Number:8400007; Recruiting

Papillion, Nebraska, United States, 68046

United States, Ohio

Optimed Research, LTD-Site Number:8400017; Recruiting

Columbus, Ohio, United States, 43235

United States, Oklahoma

Vital Prospects Clinical Research Institute, P.C.-Site Number:8400004; Recruiting

Tulsa, Oklahoma, United States, 74136

Essential Medical Research, LLC-Site Number:8400014; Recruiting

Tulsa, Oklahoma, United States, 74137

United States, Texas

Pharmaceutical Research & Consulting, Inc.-Site Number:8400006; Completed

Dallas, Texas, United States, 75231

North Texas Center for Clinical Research-Site Number:8400019; Recruiting

Frisco, Texas, United States, 75034

Alamo ENT Associates-Site Number:8400021; Recruiting

San Antonio, Texas, United States, 78258

United States, Virginia

Eastern Virginia Medical School (EVMS) Medical Group - Otola-Site Number:8400009; Recruiting

Norfolk, Virginia, United States, 23507

Argentina

Investigational Site Number :0320002; Recruiting

Buenos Aires, Argentina, C1121ABE

Investigational Site Number :0320003; Recruiting

Ciudad Autonoma Buenos Aires, Argentina, C1414AIF

Investigational Site Number :0320001; Recruiting

Ciudad Autonoma Buenos Aires, Argentina, C1425BEN

Belgium

Investigational Site Number :0560003; Recruiting

Bruxelles, Belgium, 1200

Investigational Site Number :0560002; Recruiting

Gent, Belgium, 9000

Investigational Site Number :0560001; Recruiting

Leuven, Belgium, 3000

Canada, British Columbia

Investigational Site Number :1240013; Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Canada, Ontario

Investigational Site Number :1240010; Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Investigational Site Number :1240007; Recruiting

Kingston, Ontario, Canada, K7L 2V7

Investigational Site Number :1240016; Recruiting

London, Ontario, Canada, N6A 4V2

Canada, Quebec

Investigational Site Number :1240001; Recruiting

Montreal, Quebec, Canada, H2X 3E4

Investigational Site Number :1240012; Recruiting

Montreal, Quebec, Canada, H4A 3J1

Investigational Site Number :1240002; Recruiting

Trois-Rivieres, Quebec, Canada, G8T 7A1

Canada

Investigational Site Number :1240005; Recruiting

Quebec, Canada, G1V 4G5

Investigational Site Number :1240003; Recruiting

Quebec, Canada, G1V 4W2

Chile

Investigational Site Number :1520001; Recruiting

Santiago, Reg Metropolitana De Santiago, Chile, 8207257

China

Investigational Site Number :1560015; Recruiting

Beijing, China, 100044

Investigational Site Number :1560009; Recruiting

Beijing, China, 100191

Investigational Site Number :1560001; Recruiting

Beijing, China, 100730

Investigational Site Number :1560005; Recruiting

Changchun, China, 130021

Investigational Site Number :1560013; Recruiting

Changsha, China, 410013

Investigational Site Number :1560012; Recruiting

Chengdu, China, 610041

Investigational Site Number :1560010; Recruiting

Chongqing, China, 400016

Investigational Site Number :1560002; Recruiting

Hangzhou Shi, China, 310003

Investigational Site Number :1560011; Recruiting

Qingdao, China, 266555

Investigational Site Number :1560006; Recruiting

Shanghai, China, 200065

Investigational Site Number :1560014; Recruiting

Taiyuan, China, 030001

Investigational Site Number :1560003; Recruiting

Wuhan, China, 430022

Investigational Site Number :1560004; Recruiting

Xi'an, China, 710004

Investigational Site Number :1560008; Recruiting

Yantai, China, 264000

Hungary

Investigational Site Number :3480004; Recruiting

Budapest, Hungary, 1115

Investigational Site Number :3480001; Recruiting

Pécs, Hungary, 7621

Investigational Site Number :3480002; Recruiting

Szeged, Hungary, 6725

Korea, Republic of

Investigational Site Number :4100001; Recruiting

Seoul, Seoul-teukbyeolsi, Korea, Republic of, 03080

Investigational Site Number :4100003; Recruiting

Seoul, Seoul-teukbyeolsi, Korea, Republic of, 07061

Investigational Site Number :4100002; Recruiting

Seoul, Seoul-teukbyeolsi, Korea, Republic of, 135-710

Portugal

Investigational Site Number :6200002; Recruiting

Aveiro, Portugal, 3810-501

Investigational Site Number :6200001; Recruiting

Guimarães, Portugal, 4810-061

Investigational Site Number :6200003; Recruiting

Matosinhos, Portugal, 4464-513

Russian Federation

Investigational Site Number :6430005; Completed

Moscow, Russian Federation, 121359

Investigational Site Number :6430002; Completed

St-Petersburg, Russian Federation, 197022

Investigational Site Number :6430003; Completed

St-Petersburg, Russian Federation, 197022

Investigational Site Number :6430001; Active, not recruiting

Stavropol, Russian Federation, 355020

Spain

Investigational Site Number :7240002; Recruiting

Sevilla, Andalucia, Spain, 41009

Investigational Site Number :7240001; Recruiting

Barcelona, Barcelona [Barcelona], Spain, 08036

Investigational Site Number :7240007; Recruiting

Santander, Cantabria, Spain, 39008

Investigational Site Number :7240004; Recruiting

Jerez de la Frontera, Cádiz, Spain, 11407

Investigational Site Number :7240005; Recruiting

Madrid / Madrid, Madrid, Comunidad De, Spain, 28040

Investigational Site Number :7240009; Recruiting

Madrid, Madrid, Comunidad De, Spain, 28027

Investigational Site Number :7240008; Recruiting

Pamplona, Navarra, Spain, 31008

Investigational Site Number :7240010; Recruiting

Madrid, Spain, 28034

Sweden

Investigational Site Number :7520001; Recruiting

Stockholm, Sweden, 171 76

Ukraine

Investigational Site Number :8040005; Recruiting

Dnipro, Ukraine, 49006

Investigational Site Number :8040001; Recruiting

Ivano-Frankivsk, Ukraine, 76018

Investigational Site Number :8040004; Recruiting

Kharkiv, Ukraine, 61166

Investigational Site Number :8040008; Recruiting

Kyiv, Ukraine, 01033

Investigational Site Number :8040002; Recruiting

Kyiv, Ukraine, 03680

Investigational Site Number :8040007; Recruiting

Kyiv, Ukraine, 04050

Sponsors and Collaborators

Sanofi

Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT04678856
• Other Study ID Numbers: EFC16723; 2020-003117-35 ( EudraCT Number ); U1111-1246-7522 ( Registry Identifier: ICTRP )
• First Posted: December 22, 2020
• Last Update Posted: February 28, 2023
• Last Verified: February 27, 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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

• 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

Additional relevant MeSH terms:

Sinusitis; Respiration Disorders; Respiratory Tract Diseases; Disease; Pathologic Processes; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Otorhinolaryngologic Diseases