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Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)

Primary Purpose

Allergic Fungal Rhinosinusitis

Status
Recruiting
Phase
Phase 3
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 Allergic Fungal Rhinosinusitis

Eligibility Criteria

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

Inclusion Criteria:

Participant must be at least 6 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the informed consent.

Participants with the diagnosis of AFRS adapted from criteria by Bent and Kuhn (meeting all):

  • IgE mediated inflammatory response to fungal hyphae (specific IgE serology or skin test) Evidence of sensitization to fungus by skin testing (at screening or documented historical positive skin test in the previous 12 months), or positive fungal-specific IgE in serum at screening.
  • Nasal polyposis confirmed by nasal endoscopy at screening.
  • Characteristic CT signs to be performed during screening period and can include any of the below signs as assessed by central reader:

    • hyperdensities
    • bony demineralization
    • bone erosion of sinus
  • Eosinophilic mucin/mucus identified within 5 years prior to screening or at screening with or without positive fungal stain

AFRS patients with the following:

  • An endoscopic NPS of at least 2 out of 4 for unilateral polyps or 3 out of 8 for bilateral polyps at Visit 1 (central reading) and Visit 2 (local reading) and,
  • Sinus opacification in CT scan with an LMK score of 9 for patients with unilateral polyps or 12 for patients with bilateral polyps during screening period and,

History of sino-nasal surgery(ies).

Body weight ≥15 kg

Exclusion Criteria:

  • Patients with nasal conditions/concomitant nasal diseases making them non-evaluable at Visit 1 or for the primary efficacy
  • Nasal cavity malignant tumor and benign tumors.
  • Known of fungal invasion into sinus tissue.
  • Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's 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
  • 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.
  • Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab. - 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.
  • Patients who are on INCS spray unless they have received stable dose for at least 4 weeks prior to Visit 1.
  • 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. - 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

  • Asthma Allergy & Immunology Clinical Research Unit-Site Number:8400001Recruiting
  • Emory University Hospital Midtown Campus-Site Number:8400009Recruiting
  • Advanced ENT and Allergy-Site Number:8400004
  • South Louisiana Ear, Nose, Throat and Facial Plastic Surgery-Site Number:8400019Recruiting
  • National Allergy and Asthma Research, LLC-Site Number:8400002
  • Vanderbilt University Medical Center-Site Number:8400013
  • Ut- Houston Medical School-Site Number:8400010Recruiting
  • Alamo ENT Associates-Site Number:8400018Recruiting
  • Eastern Virginia Medical School (EVMS) Medical Group - Otola-Site Number:8400008Recruiting
  • Investigational Site Number :0320003Recruiting
  • Investigational Site Number :0320001Recruiting
  • Investigational Site Number :0320005Recruiting
  • Investigational Site Number :0320002Recruiting
  • Investigational Site Number :0320004Recruiting
  • Investigational Site Number :1240001Recruiting
  • Investigational Site Number :1560005Recruiting
  • Investigational Site Number :1560001Recruiting
  • Investigational Site Number :1560004Recruiting
  • Investigational Site Number :1560003Recruiting
  • Investigational Site Number :1560013Recruiting
  • Investigational Site Number :1560010Recruiting
  • Investigational Site Number :1560006Recruiting
  • Investigational Site Number :1560012Recruiting
  • Investigational Site Number :1560002Recruiting
  • Investigational Site Number :1560011Recruiting
  • Investigational Site Number :1560009Recruiting
  • Investigational Site Number :1560008
  • Investigational Site Number :3560003Recruiting
  • Investigational Site Number :3560006Recruiting
  • Investigational Site Number :3560008Recruiting
  • Investigational Site Number :3760001
  • Investigational Site Number :3760002
  • Investigational Site Number :3920005Recruiting
  • Investigational Site Number :3920010Recruiting
  • Investigational Site Number :3920006Recruiting
  • Investigational Site Number :3920008Recruiting
  • Investigational Site Number :3920007Recruiting
  • Investigational Site Number :3920001Recruiting
  • Investigational Site Number :3920004Recruiting
  • Investigational Site Number :3920003Recruiting
  • Investigational Site Number :3920009Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dupilumab

Matching placebo

Arm Description

Dupilumab administered every 2 or 4 weeks based on weights

Placebo administered every 2 or 4 weeks based on weights

Outcomes

Primary Outcome Measures

Change from baseline in sinus opacifications assessed by computerized tomography (CT) scans using the Lund Mackay (LMK) score at 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).

Secondary Outcome Measures

Change from baseline in sinus opacifications assessed by CT scans using the LMK score at 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).
Proportion of patients who receive systemic corticosteroids (SCS) and/or undergo/plan to undergo surgery for AFRS during the planned study treatment period
Change from baseline in monthly average nasal congestion/obstruction score from the Nasal symptom Diary at Week 24 and Week 52
The nasal congestion/obstruction scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').
Change from Baseline in the monthly average anterior/posterior rhinorrhea score from the Nasal Symptom Diary at Week 24 and Week 52
The rhinorrhea scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').
Change from baseline in endoscopic NPS compared to placebo at Week 24 and Week 52
The total nasal polyps score (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 in 22-item sino-nasal outcome test (SNOT-22) total score at Week 24 and Week 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.
Change from baseline in monthly average total symptom score (TSS) derived from the Nasal Symptom Diary at Week 24 and Week 52
TSS ranges from 0 to 9. Higher scores on the TSS indicate greater symptom severity.
Change from baseline in visual analog scale (VAS) rhinosinusitis at Week 24 and Week 52
VAS score ranges from 0 ('not troublesome') to 10 ('worst thinkable troublesome').
Change from baseline in University of Pennsylvania smell identification test (UPSIT) at Week 24 and Week 52
The UPSIT score ranges from 0 to 40, with 40 being the best possible score.
Change from baseline in the score of decreased/loss of smell using the Nasal Symptom Diary at Week 24 and Week 52
The decreased/loss of smell scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').
Change from baseline to Week 52 in three Dimensional CT volumetric measurement of the paranasal sinuses
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Dupilumab concentration in serum over time
Percent change from baseline in total IgE in serum compared to placebo over the 52 weeks treatment period
Percent change from baseline in fungal-specific IgE in serum compared to placebo over the 52 weeks treatment period
Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time
Enter Endpoint Secondary

Full Information

First Posted
December 21, 2020
Last Updated
September 21, 2023
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04684524
Brief Title
Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)
Official Title
A Randomized Double-blind Placebo-controlled Parallel Group Study Assessing the Efficacy and Safety of Dupilumab in Patients With Allergic Fungal Rhinosinusitis (AFRS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 21, 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 27, 2024 (Anticipated)
Study Completion Date
March 21, 2025 (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 treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) Secondary Objectives: To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) at Week 24 To assess the efficacy of dupilumab to reduce the need for rescue treatments To evaluate the efficacy of treatment with dupilumab in improving symptoms in AFRS To evaluate the efficacy of dupilumab to reduce nasal polyp formation in participants with AFRS To evaluate the efficacy of dupilumab in improving overall symptom severity and quality of life in AFRS To evaluate the efficacy of dupilumab in improving sense of smell in participants with AFRS To explore the effect of dupilumab as assessed by three-Dimensional CT volumetric measurement of the paranasal sinuses To evaluate the safety and tolerability of dupilumab when administered to participants with AFRS To evaluate the pharmacokinetics (PK) of dupilumab in participants with AFRS To characterize the effect of dupilumab on total IgE and specific IgE To assess immunogenicity to dupilumab in participants with AFRS
Detailed Description
The duration of study for each participant will include 2-4 weeks of screening period (2 additional weeks could be allowed), 52 weeks of 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
Allergic Fungal Rhinosinusitis

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 administered every 2 or 4 weeks based on weights
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered every 2 or 4 weeks based on weights
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 in sinus opacifications assessed by computerized tomography (CT) scans using the Lund Mackay (LMK) score at Week 52
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 52
Secondary Outcome Measure Information:
Title
Change from baseline in sinus opacifications assessed by CT scans using the LMK score at Week 24
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
Proportion of patients who receive systemic corticosteroids (SCS) and/or undergo/plan to undergo surgery for AFRS during the planned study treatment period
Time Frame
Baseline to Week 52
Title
Change from baseline in monthly average nasal congestion/obstruction score from the Nasal symptom Diary at Week 24 and Week 52
Description
The nasal congestion/obstruction scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').
Time Frame
Baseline to Week 24 and Week 52
Title
Change from Baseline in the monthly average anterior/posterior rhinorrhea score from the Nasal Symptom Diary at Week 24 and Week 52
Description
The rhinorrhea scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').
Time Frame
Baseline to Week 24 and Week 52
Title
Change from baseline in endoscopic NPS compared to placebo at Week 24 and Week 52
Description
The total nasal polyps score (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 and Week 52
Title
Change from baseline in 22-item sino-nasal outcome test (SNOT-22) total score at Week 24 and Week 52
Description
SNOT-22 is a patient-reported outcome (PRO) questionnaire. Score ranges from 0 to 110 with higher score indicating greater rhinosinusitis related health burden.
Time Frame
Baseline to Week 24 and Week 52
Title
Change from baseline in monthly average total symptom score (TSS) derived from the Nasal Symptom Diary at Week 24 and Week 52
Description
TSS ranges from 0 to 9. Higher scores on the TSS indicate greater symptom severity.
Time Frame
Baseline to Week 24 and Week 52
Title
Change from baseline in visual analog scale (VAS) rhinosinusitis at Week 24 and Week 52
Description
VAS score ranges from 0 ('not troublesome') to 10 ('worst thinkable troublesome').
Time Frame
Baseline to Week 24 and Week 52
Title
Change from baseline in University of Pennsylvania smell identification test (UPSIT) at Week 24 and Week 52
Description
The UPSIT score ranges from 0 to 40, with 40 being the best possible score.
Time Frame
Baseline to Week 24 and Week 52
Title
Change from baseline in the score of decreased/loss of smell using the Nasal Symptom Diary at Week 24 and Week 52
Description
The decreased/loss of smell scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms').
Time Frame
Baseline to Week 24 and Week 52
Title
Change from baseline to Week 52 in three Dimensional CT volumetric measurement of the paranasal sinuses
Time Frame
Baseline to Week 52
Title
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Time Frame
Baseline to Week 64
Title
Dupilumab concentration in serum over time
Time Frame
Baseline to Week 52
Title
Percent change from baseline in total IgE in serum compared to placebo over the 52 weeks treatment period
Time Frame
Baseline to Week 52
Title
Percent change from baseline in fungal-specific IgE in serum compared to placebo over the 52 weeks treatment period
Time Frame
Baseline to Week 52
Title
Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time
Description
Enter Endpoint Secondary
Time Frame
Baseline to Week 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must be at least 6 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the informed consent. Participants with the diagnosis of AFRS adapted from criteria by Bent and Kuhn (meeting all): IgE mediated inflammatory response to fungal hyphae (specific IgE serology or skin test) Evidence of sensitization to fungus by skin testing (at screening or documented historical positive skin test in the previous 12 months), or positive fungal-specific IgE in serum at screening. Nasal polyposis confirmed by nasal endoscopy at screening. Characteristic CT signs to be performed during screening period and can include any of the below signs as assessed by central reader: hyperdensities bony demineralization bone erosion of sinus Eosinophilic mucin/mucus identified within 5 years prior to screening or at screening with or without positive fungal stain AFRS patients with the following: An endoscopic NPS of at least 2 out of 4 for unilateral polyps or 3 out of 8 for bilateral polyps at Visit 1 (central reading) and Visit 2 (local reading) and, Sinus opacification in CT scan with an LMK score of 9 for patients with unilateral polyps or 12 for patients with bilateral polyps during screening period and, Body weight ≥15 kg Exclusion Criteria: Patients with nasal conditions/concomitant nasal diseases making them non-evaluable at Visit 1 or for the primary efficacy Nasal cavity malignant tumor and benign tumors. Known of fungal invasion into sinus tissue. Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's 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 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. Treatment with commercially available dupilumab within 12 months, participation in prior dupilumab clinical trial, or 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. Patients who are on intranasal corticosteroids (INCS) spray unless they have received stable dose for at least 4 weeks prior to Visit 1. 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. - 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
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
Asthma Allergy & Immunology Clinical Research Unit-Site Number:8400001
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University Hospital Midtown Campus-Site Number:8400009
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced ENT and Allergy-Site Number:8400004
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Individual Site Status
Completed
Facility Name
South Louisiana Ear, Nose, Throat and Facial Plastic Surgery-Site Number:8400019
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Individual Site Status
Recruiting
Facility Name
National Allergy and Asthma Research, LLC-Site Number:8400002
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center-Site Number:8400013
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Completed
Facility Name
Ut- Houston Medical School-Site Number:8400010
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Alamo ENT Associates-Site Number:8400018
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern Virginia Medical School (EVMS) Medical Group - Otola-Site Number:8400008
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320003
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320005
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320002
City
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320004
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240001
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560005
City
Beijing
ZIP/Postal Code
100050
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 :1560004
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560003
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560013
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560010
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560006
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560012
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560002
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560011
City
Qingdao
ZIP/Postal Code
266555
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560009
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560008
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Individual Site Status
Completed
Facility Name
Investigational Site Number :3560003
City
Coimbatore
ZIP/Postal Code
641028
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560006
City
Jodhpur
ZIP/Postal Code
342005
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560008
City
New Delhi
ZIP/Postal Code
110 062.
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760001
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Completed
Facility Name
Investigational Site Number :3760002
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Individual Site Status
Completed
Facility Name
Investigational Site Number :3920005
City
Narita-shi
State/Province
Chiba
ZIP/Postal Code
286-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920010
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
2591193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920006
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
420-0853
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920008
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920007
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920001
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920004
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920003
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920009
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
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 Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)

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