- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04678856
Dupilumab in CRSsNP (Liberty CRSsNP)
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)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Trial Transparency email recommended (Toll free number for US & Canada)
- Phone Number: option 6 800-633-1610
- Email: Contact-Us@sanofi.com
Study Locations
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Buenos Aires, Argentina, C1121ABE
- Investigational Site Number : 0320002
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Ciudad Autonoma Buenos Aires, Argentina, C1414AIF
- Investigational Site Number : 0320003
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Ciudad Autonoma Buenos Aires, Argentina, C1425BEN
- Investigational Site Number : 0320001
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Gent, Belgium, 9000
- Investigational Site Number : 0560002
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Leuven, Belgium, 3000
- Investigational Site Number : 0560001
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Quebec, Canada, G1V 4G5
- Investigational Site Number : 1240005
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Quebec, Canada, G1V 4W2
- Investigational Site Number : 1240003
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Investigational Site Number : 1240013
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Investigational Site Number : 1240010
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Kingston, Ontario, Canada, K7L 2V7
- Investigational Site Number : 1240007
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London, Ontario, Canada, N6A 4V2
- Investigational Site Number : 1240016
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- Investigational Site Number : 1240001
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Montreal, Quebec, Canada, H4A 3J1
- Investigational Site Number : 1240012
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Trois-Rivieres, Quebec, Canada, G8T 7A1
- Investigational Site Number : 1240002
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Reg Metropolitana De Santiago
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Santiago, Reg Metropolitana De Santiago, Chile, 8207257
- Investigational Site Number : 1520001
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Beijing, China, 100730
- Investigational Site Number : 1560001
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Changchun, China, 130021
- Investigational Site Number : 1560005
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Changsha, China, 410013
- Investigational Site Number : 1560013
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Chongqing, China, 400016
- Investigational Site Number : 1560010
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Shanghai, China, 200065
- Investigational Site Number : 1560006
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Yantai, China, 264000
- Investigational Site Number : 1560008
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Budapest, Hungary, 1115
- Investigational Site Number : 3480004
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Pécs, Hungary, 7621
- Investigational Site Number : 3480001
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Seoul-teukbyeolsi
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Seoul, Seoul-teukbyeolsi, Korea, Republic of, 07061
- Investigational Site Number : 4100003
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Seoul, Seoul-teukbyeolsi, Korea, Republic of, 135-710
- Investigational Site Number : 4100002
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Aveiro, Portugal, 3810-501
- Investigational Site Number : 6200002
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Guimarães, Portugal, 4810-061
- Investigational Site Number : 6200001
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Matosinhos, Portugal, 4464-513
- Investigational Site Number : 6200003
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Moscow, Russian Federation, 121359
- Investigational Site Number : 6430005
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St-Petersburg, Russian Federation, 197022
- Investigational Site Number : 6430002
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St-Petersburg, Russian Federation, 197022
- Investigational Site Number : 6430003
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Stavropol, Russian Federation, 355020
- Investigational Site Number : 6430001
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Madrid, Spain, 28034
- Investigational Site Number : 7240010
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Andalucia
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Sevilla, Andalucia, Spain, 41009
- Investigational Site Number : 7240002
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Barcelona [Barcelona]
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Barcelona, Barcelona [Barcelona], Spain, 08036
- Investigational Site Number : 7240001
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Cantabria
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Santander, Cantabria, Spain, 39008
- Investigational Site Number : 7240007
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Cádiz
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Jerez de la Frontera, Cádiz, Spain, 11407
- Investigational Site Number : 7240004
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Madrid, Comunidad De
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Madrid, Madrid, Comunidad De, Spain, 28027
- Investigational Site Number : 7240009
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Madrid / Madrid, Madrid, Comunidad De, Spain, 28040
- Investigational Site Number : 7240005
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Navarra
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Pamplona, Navarra, Spain, 31008
- Investigational Site Number : 7240008
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Stockholm, Sweden, 171 76
- Investigational Site Number : 7520001
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Dnipro, Ukraine, 49006
- Investigational Site Number : 8040005
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Ivano-Frankivsk, Ukraine, 76018
- Investigational Site Number : 8040001
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Kharkiv, Ukraine, 61166
- Investigational Site Number : 8040004
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Kyiv, Ukraine, 01033
- Investigational Site Number : 8040008
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Kyiv, Ukraine, 03680
- Investigational Site Number : 8040002
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Kyiv, Ukraine, 04050
- Investigational Site Number : 8040007
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California
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Roseville, California, United States, 95661
- Sacramento Ear, Nose & Throat Site Number : 8400010
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Stockton, California, United States, 95207
- Bensch Clinical Research LLC Site Number : 8400015
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Colorado
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Denver, Colorado, United States, 80230
- Colorado Allergy and Asthma Centers, PC Site Number : 8400003
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri Health System Site Number : 8400016
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Nebraska
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Papillion, Nebraska, United States, 68046
- Nebraska Medical Research Institute Site Number : 8400007
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Ohio
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Columbus, Ohio, United States, 43235
- Optimed Research, LTD Site Number : 8400017
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Vital Prospects Clinical Research Institute, P.C. Site Number : 8400004
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Tulsa, Oklahoma, United States, 74137
- Essential Medical Research, LLC Site Number : 8400014
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Texas
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Dallas, Texas, United States, 75231
- Pharmaceutical Research & Consulting, Inc. Site Number : 8400006
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San Antonio, Texas, United States, 78258
- Alamo ENT Associates Site Number : 8400021
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Virginia
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Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School (EVMS) Medical Group - Otola Site Number : 8400009
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Part A and B: Dupilumab
Dupilumab administered every 2 weeks.
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Pharmaceutical form:Injection solution Route of administration: Subcutaneous
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Placebo Comparator: Part A and B: Matching placebo
Placebo administered every 2 weeks
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Pharmaceutical form:Injection solution Route of administration: Subcutaneous
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline to Week 24
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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).
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Baseline to Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to Week 24 in opacification of sinuses assessed by CT scan using the LMK score
Time Frame: Baseline to Week 24
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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).
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Baseline to Week 24
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Change from baseline to Week 24 in sTSS
Time Frame: Baseline to Week 24
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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.
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Baseline to Week 24
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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
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Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), and TEAEs leading to treatment discontinuation.
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Baseline to Week 64
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Dupilumab concentration in serum
Time Frame: Baseline to Week 52
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Dupilumab concentration in serum.
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Baseline to Week 52
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Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time
Time Frame: Baseline to Week 64
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Incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time.
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Baseline to Week 64
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC16723
- 2020-003117-35 (EudraCT Number)
- U1111-1246-7522 (Registry Identifier: ICTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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