Actively Recruiting
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Led by Sanofi · Updated on 2026-04-24
210
Participants Needed
113
Research Sites
148 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older. Study details include: * The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks. * The treatment duration will be up to 52 weeks. * The number of visits will be 9 site visits and 20 phone/home visits.
CONDITIONS
Official Title
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older.
- History of chronic rhinosinusitis with nasal polyps for at least 1 year prior to screening.
- Prior sinonasal surgery for nasal polyps or worsening symptoms needing systemic corticosteroids within the last year.
- Endoscopic bilateral Nasal Polyp Score of at least 5 with a minimum score of 2 in each nasal cavity at screening and randomization.
- Ongoing symptoms for at least 12 weeks before screening including moderate or severe nasal congestion and at least one of loss of smell or rhinorrhea.
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to use highly effective contraception during the study and for 20 weeks after last dose.
You will not qualify if you...
- History of significant medical illnesses affecting renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding asthma and aspirin-exacerbated respiratory disease), gastrointestinal, cardiovascular, cerebrovascular, or other conditions that could interfere with the study.
- Current tobacco smoking or vaping, or cessation less than 6 months prior to screening.
- Contraindications to mometasone furoate nasal spray such as hypersensitivity or uncontrolled opportunistic infections.
- History of severe systemic hypersensitivity reaction to monoclonal antibodies.
- Conditions or diseases making participants non-evaluable for primary efficacy.
- Nasal cavity malignant or benign tumors.
- Severe uncontrolled asthma with frequent exacerbations or hospitalizations requiring systemic corticosteroids.
- Concomitant lung diseases other than asthma that could affect lung function tests.
- Use of intranasal corticosteroids other than mometasone furoate nasal spray or nasal devices during screening.
- Sinus surgery within 6 months before screening.
- Systemic corticosteroid use within 1 month prior to screening or during screening.
- Known allergy to itepekimab, its components, or any drug allergy contraindicating study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 113 locations
1
Excel ENT of Alabama- Site Number : 8400052
Birmingham, Alabama, United States, 35244
Actively Recruiting
2
Velocity Clinical Research - San Diego- Site Number : 8400041
La Mesa, California, United States, 91942
Actively Recruiting
3
Cedars-Sinai Medical Center- Site Number : 8400030
Los Angeles, California, United States, 90048
Actively Recruiting
4
One of a Kind CLinical Research Center- Site Number : 8400034
Napa, California, United States, 94558
Actively Recruiting
5
University of Florida - Jacksonville- Site Number : 8400053
Jacksonville, Florida, United States, 32209
Actively Recruiting
6
University of Miami Don Suffer Clinical Research Building- Site Number : 8400036
Miami, Florida, United States, 33136
Actively Recruiting
7
Advanced Research Institute - New Port Richey- Site Number : 8400014
New Port Richey, Florida, United States, 34653
Actively Recruiting
8
University of Illinois at Chicago- Site Number : 8400003
Chicago, Illinois, United States, 60607
Actively Recruiting
9
Advanced ENT & Allergy - Louisville- Site Number : 8400007
Louisville, Kentucky, United States, 40220
Actively Recruiting
10
Velocity Clinical Research - Lafayette- Site Number : 8400026
Lafayette, Louisiana, United States, 70508
Actively Recruiting
11
Johns Hopkins Hospital- Site Number : 8400017
Baltimore, Maryland, United States, 21287
Actively Recruiting
12
University of Cincinnati Medical Center- Site Number : 8400022
Cincinnati, Ohio, United States, 45219
Actively Recruiting
13
Allergy, Asthma and Clinical Research- Site Number : 8400002
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
14
Thomas Jefferson University Hospital- Site Number : 8400044
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
15
Spartanburg-Greer ENT & Allergy- Site Number : 8400039
Greer, South Carolina, United States, 29650
Actively Recruiting
16
Ear and Sinus Institute- Site Number : 8400048
Fort Worth, Texas, United States, 76104
Actively Recruiting
17
Investigational Site Number : 0320005
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
18
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1121
Actively Recruiting
19
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1414
Actively Recruiting
20
Investigational Site Number : 0320004
Corrientes, Argentina, 3400
Actively Recruiting
21
Investigational Site Number : 0320003
Mendoza, Argentina, 5500
Actively Recruiting
22
Investigational Site Number : 0360003
Bella Vista, New South Wales, Australia, 2153
Actively Recruiting
23
Investigational Site Number : 0360002
Brisbane, Queensland, Australia, 4029
Actively Recruiting
24
Investigational Site Number : 0360001
Spearwood, Western Australia, Australia, 6163
Actively Recruiting
25
Investigational Site Number : 0560004
Gesves, Namur, Belgium, 5340
Actively Recruiting
26
Investigational Site Number : 0560006
Alken, Belgium, 3570
Actively Recruiting
27
Investigational Site Number : 0560002
Ghent, Belgium, 9000
Actively Recruiting
28
Investigational Site Number : 0560001
Leuven, Belgium, 3000
Actively Recruiting
29
Private Practice - Dr. Nelson Rosário- Site Number : 0760001
Curitiba, Paraná, Brazil, 80810-100
Actively Recruiting
30
Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002
Marília, São Paulo, Brazil, 17504-072
Actively Recruiting
31
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760005
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
32
Clinica de Alergia Martti Antila- Site Number : 0760003
Sorocaba, São Paulo, Brazil, 18040-425
Actively Recruiting
33
Investigational Site Number : 1240017
Vancouver, British Columbia, Canada, V6A 2W1
Actively Recruiting
34
Investigational Site Number : 1240019
Burlington, Ontario, Canada, L7R 3P9
Actively Recruiting
35
Investigational Site Number : 1240015
Cambridge, Ontario, Canada, N1R 8L4
Actively Recruiting
36
Investigational Site Number : 1240014
Ottawa, Ontario, Canada, K1G 6C6
Actively Recruiting
37
Investigational Site Number : 1240003
Québec, Quebec, Canada, G1V 4W2
Actively Recruiting
38
Investigational Site Number : 1240012
Québec, Quebec, Canada, G2J 0C4
Actively Recruiting
39
Investigational Site Number : 1520001
Concepción, Biobio, Chile, 4070094
Actively Recruiting
40
Investigational Site Number : 1520004
Talcahuano, Biobio, Chile, 2687000
Actively Recruiting
41
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile, 7500505
Actively Recruiting
42
Investigational Site Number : 1520002
Quillota, Valparaiso, Chile, 2260877
Actively Recruiting
43
Investigational Site Number : 1560020
Baotou, China, 014040
Active, Not Recruiting
44
Investigational Site Number : 1560001
Beijing, China, 100730
Active, Not Recruiting
45
Investigational Site Number : 1560004
Chengdu, China, 610017
Active, Not Recruiting
46
Investigational Site Number : 1560025
Chongqing, China, 400016
Active, Not Recruiting
47
Investigational Site Number : 1560019
Hangzhou, China, 310003
Active, Not Recruiting
48
Investigational Site Number : 1560005
Hefei, China, 230001
Actively Recruiting
49
Investigational Site Number : 1560002
Jinan, China, 250022
Active, Not Recruiting
50
Investigational Site Number : 1560012
Jingzhou, China, 434020
Active, Not Recruiting
51
Investigational Site Number : 1560021
Nanning, China, 530021
Active, Not Recruiting
52
Investigational Site Number : 1560006
Shenyang, China, 110004
Active, Not Recruiting
53
Investigational Site Number : 1560024
Suzhou, China, 215006
Active, Not Recruiting
54
Investigational Site Number : 1560017
Taiyuan, China, 030001
Active, Not Recruiting
55
Investigational Site Number : 1560023
Taiyuan, China, 030001
Active, Not Recruiting
56
Investigational Site Number : 1560014
Wuhan, China, 430060
Active, Not Recruiting
57
Investigational Site Number : 1560003
Yantai, China, 264001
Completed
58
Investigational Site Number : 1560009
Zibo, China, 255036
Active, Not Recruiting
59
Investigational Site Number : 2030002
Hradec Králové, Czechia, 500 05
Actively Recruiting
60
Investigational Site Number : 2030003
Pardubice, Czechia, 532 03
Actively Recruiting
61
Investigational Site Number : 2030005
Pilsen, Czechia, 305 99
Actively Recruiting
62
Investigational Site Number : 2030004
Prague, Czechia, 100 34
Actively Recruiting
63
Investigational Site Number : 2030001
Prague, Czechia, 150 06
Actively Recruiting
64
Investigational Site Number : 2080001
Aarhus, Denmark, 8200
Actively Recruiting
65
Investigational Site Number : 2080004
Copenhagen, Denmark, 2100
Actively Recruiting
66
Investigational Site Number : 2080002
Køge, Denmark, 4600
Actively Recruiting
67
Investigational Site Number : 2500011
Bordeaux, France, 33076
Actively Recruiting
68
Investigational Site Number : 2500004
Marseille, France, 13005
Actively Recruiting
69
Investigational Site Number : 2500001
Nantes, France, 44093
Actively Recruiting
70
Investigational Site Number : 2500010
Poitiers, France, 86021
Actively Recruiting
71
Investigational Site Number : 2500014
Pontoise, France, 95300
Actively Recruiting
72
Investigational Site Number : 2500007
Toulouse, France, 31059
Actively Recruiting
73
Investigational Site Number : 2760006
Dresden, Germany, 01139
Actively Recruiting
74
Investigational Site Number : 2760001
Dresden, Germany, 01307
Actively Recruiting
75
Investigational Site Number : 2760005
Hamburg, Germany, 20246
Actively Recruiting
76
Investigational Site Number : 2760002
Leipzig, Germany, 04103
Actively Recruiting
77
Investigational Site Number : 2760007
Mainz, Germany, 55131
Actively Recruiting
78
Investigational Site Number : 2760008
Villingen-Schwenningen, Germany, 78052
Actively Recruiting
79
Investigational Site Number : 3480005
Budapest, Hungary, 1026
Actively Recruiting
80
Investigational Site Number : 3480001
Szeged, Hungary, 6720
Actively Recruiting
81
Investigational Site Number : 3760003
Haifa, Israel, 3104802
Actively Recruiting
82
Investigational Site Number : 3760004
Jerusalem, Israel, 9112001
Actively Recruiting
83
Investigational Site Number : 3760001
Nahariya, Israel, 2210001
Actively Recruiting
84
Investigational Site Number : 3760002
Rehovot, Israel, 7610001
Actively Recruiting
85
Investigational Site Number : 3800001
Milan, Milano, Italy, 20132
Actively Recruiting
86
Investigational Site Number : 3800005
Naples, Napoli, Italy, 80131
Actively Recruiting
87
Investigational Site Number : 3800003
Catania, Italy, 95123
Actively Recruiting
88
Investigational Site Number : 2500005
Toyama, Japan, 939-2716
Actively Recruiting
89
Investigational Site Number : 4840001
Guadalajara, Jalisco, Mexico, 44100
Actively Recruiting
90
Investigational Site Number : 4840008
Monterrey, Nuevo León, Mexico, 64718
Actively Recruiting
91
Investigational Site Number : 4840007
Chihuahua City, Mexico, 31217
Actively Recruiting
92
Investigational Site Number : 4840002
Veracruz, Mexico, 91900
Actively Recruiting
93
Investigational Site Number : 5280002
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
94
Investigational Site Number : 5280001
Utrecht, Netherlands, 3584 CX
Actively Recruiting
95
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, Poland, 60-693
Actively Recruiting
96
Investigational Site Number : 6160005
Wroclaw, Lower Silesian Voivodeship, Poland, 50-750
Actively Recruiting
97
Investigational Site Number : 6160002
Lodz, Lódzkie, Poland, 90-302
Actively Recruiting
98
Investigational Site Number : 6160001
Bielsko-Biala, Silesian Voivodeship, Poland, 43-300
Actively Recruiting
99
Investigational Site Number : 6420003
Brasov, Romania, 500091
Actively Recruiting
100
Investigational Site Number : 6420002
Brasov, Romania, 500283
Actively Recruiting
101
Investigational Site Number : 6420001
Bucharest, Romania, 022328
Actively Recruiting
102
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona], Spain, 08003
Actively Recruiting
103
Investigational Site Number : 7240002
Santander, Cantabria, Spain, 39008
Active, Not Recruiting
104
Investigational Site Number : 7240004
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain, 08907
Actively Recruiting
105
Investigational Site Number : 7240008
Pamplona, Navarre, Spain, 31008
Actively Recruiting
106
Investigational Site Number : 7240010
Madrid, Spain, 28034
Actively Recruiting
107
Investigational Site Number : 7240012
Madrid, Spain, 28040
Actively Recruiting
108
Investigational Site Number : 7920003
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
109
Investigational Site Number : 7920001
Bursa, Turkey (Türkiye), 16059
Actively Recruiting
110
Investigational Site Number : 7920002
Istanbul, Turkey (Türkiye), 34360
Actively Recruiting
111
Investigational Site Number : 8260002
Wigan, Lancashire, United Kingdom, Wn6 9ep
Actively Recruiting
112
Investigational Site Number : 8260001
London, London, City of, United Kingdom, W2 1NY
Actively Recruiting
113
Investigational Site Number : 8260003
Taunton, Somerset, United Kingdom, TA1 5DA
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here