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 2026-04-28
210
Participants Needed
121
Research Sites
147 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
EFC18418 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.
- Participants must have a history of chronic rhinosinusitis with nasal polyps for at least 1 year before screening.
- Participants must have at least one of the following: prior sinonasal surgery for nasal polyps or worsening symptoms requiring systemic corticosteroids within the prior year.
- Participants must have an endoscopic bilateral Nasal Polyp Score of at least 5 (minimum score of 2 in each nasal cavity) at screening and randomization.
- Participants must have ongoing symptoms for at least 12 weeks before screening, including nasal congestion with moderate or severe severity and at least one of loss of smell or rhinorrhea.
- Female participants must not be pregnant or breastfeeding and either not be women of childbearing potential or agree to use a highly effective contraceptive method during the study and for at least 20 weeks after the last dose.
You will not qualify if you...
- Participants with a history of significant medical illnesses that could interfere with the study, including renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding asthma and aspirin-exacerbated respiratory disease), gastrointestinal, cardiovascular, cerebrovascular, or other serious disorders.
- Participants currently smoking tobacco or vaping, or who quit less than 6 months before screening.
- Participants with contraindications to mometasone furoate nasal spray or uncontrolled infections.
- Participants with a history of severe systemic hypersensitivity to monoclonal antibodies.
- Participants with conditions making them non-evaluable at screening or for primary efficacy.
- Participants with nasal cavity malignant or benign tumors.
- Participants with severe uncontrolled asthma with multiple exacerbations or hospitalizations requiring systemic corticosteroids in the past year.
- Participants with lung diseases other than asthma that could interfere with lung function tests.
- Participants treated with intranasal corticosteroids (other than MFNS where permitted) or certain nasal devices during screening.
- Participants with sinus surgery within 6 months before screening.
- Participants who received systemic corticosteroids within 1 month before or during screening.
- Participants allergic to itepekimab or its components or with other allergies that contraindicate study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 121 locations
1
University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037
Arcadia, California, United States, 91006
Actively Recruiting
2
Sensa Health- Site Number : 8400038
Los Angeles, California, United States, 90006
Actively Recruiting
3
Newport Native MD- Site Number : 8400031
Newport Beach, California, United States, 92663
Actively Recruiting
4
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400064
Roseville, California, United States, 95661
Actively Recruiting
5
Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040
Torrance, California, United States, 90503
Actively Recruiting
6
Orso Health - Torrance - Hawthorne Boulevard- Site Number : 8400035
Torrance, California, United States, 90505
Actively Recruiting
7
Advanced Research Associates (ARA) Professionals- Site Number : 8400011
Miami, Florida, United States, 33176
Actively Recruiting
8
Paradisus Med Research - Miami- Site Number : 8400009
Miami, Florida, United States, 33185
Actively Recruiting
9
Orlando ENT Associates - Orlando- Site Number : 8400008
Orlando, Florida, United States, 32807
Actively Recruiting
10
Emory University School of Medicine- Grady Campus- Site Number : 8400047
Atlanta, Georgia, United States, 30303
Actively Recruiting
11
Treasure Valley Medical Research- Site Number : 8400063
Boise, Idaho, United States, 83706
Actively Recruiting
12
University of Chicago Medical Center- Site Number : 8400018
Chicago, Illinois, United States, 60637
Actively Recruiting
13
Deaconess Clinic Allergy East- Site Number : 8400056
Evansville, Indiana, United States, 47715
Actively Recruiting
14
SSM Health Saint Louis University Hospital- Site Number : 8400005
St Louis, Missouri, United States, 63104
Actively Recruiting
15
Northwell Health Physician Partners Rheumatology at Great Neck- Site Number : 8400028
Great Neck, New York, United States, 11021
Actively Recruiting
16
Essential Medical Research- Site Number : 8400066
Tulsa, Oklahoma, United States, 74137
Actively Recruiting
17
TEN20 Clinical Research - Dallas- Site Number : 8400015
Dallas, Texas, United States, 75244
Actively Recruiting
18
Houston Methodist Hospital- Site Number : 8400054
Houston, Texas, United States, 77030
Actively Recruiting
19
ENT Associates of Texas - McKinne- Site Number : 8400062
McKinney, Texas, United States, 75070
Actively Recruiting
20
Alamo ENT Associates- Site Number : 8400065
San Antonio, Texas, United States, 78258
Actively Recruiting
21
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400046
Norfolk, Virginia, United States, 23510
Actively Recruiting
22
Investigational Site Number : 0320002
La Plata, Buenos Aires, Argentina, 1900
Actively Recruiting
23
Investigational Site Number : 0320004
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
24
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1425
Actively Recruiting
25
Investigational Site Number : 0320005
Buenos Aires, Argentina, 1638
Actively Recruiting
26
Investigational Site Number : 0320003
Mendoza, Argentina, 5500
Actively Recruiting
27
Investigational Site Number : 0400005
Graz, Austria, 8036
Actively Recruiting
28
Investigational Site Number : 0400002
Linz, Austria, 4010
Actively Recruiting
29
Investigational Site Number : 0400001
Vienna, Austria, 1090
Actively Recruiting
30
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760002
Ribeirão Preto, São Paulo, Brazil, 14049-900
Actively Recruiting
31
Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760005
São José dos Campos, São Paulo, Brazil, 12230-001
Actively Recruiting
32
Hospital Israelita Albert Einstein- Site Number : 0760001
São Paulo, Brazil, 05651-901
Actively Recruiting
33
Investigational Site Number : 1240005
London, Ontario, Canada, N6A 4V2
Actively Recruiting
34
Investigational Site Number : 1240002
Montreal, Quebec, Canada, H4a 3j1
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35
Investigational Site Number : 1240001
Québec, Quebec, Canada, G1V 4G5
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36
Investigational Site Number : 1520006
Valdivia, Los Ríos Region, Chile, 5110683
Actively Recruiting
37
Investigational Site Number : 1520003
Talca, Maule Region, Chile, 3465584
Actively Recruiting
38
Investigational Site Number : 1520004
Lo Barnechea, Reg Metropolitana de Santiago, Chile, 7691236
Actively Recruiting
39
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile, 7500692
Actively Recruiting
40
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile, 8207257
Actively Recruiting
41
Investigational Site Number : 1520005
Viña del Mar, Valparaiso, Chile, 2540364
Actively Recruiting
42
Investigational Site Number : 2460004
Helsinki, Finland, 00029
Actively Recruiting
43
Investigational Site Number : 2460003
Helsinki, Finland, 00130
Actively Recruiting
44
Investigational Site Number : 2460002
Kuopio, Finland, 70210
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45
Investigational Site Number : 2760004
Berlin, Germany, 10117
Actively Recruiting
46
Investigational Site Number : 2760007
Frankfurt, Germany, 60318
Actively Recruiting
47
Investigational Site Number : 2760008
Hamburg, Germany, 22523
Actively Recruiting
48
Investigational Site Number : 2760009
Landsberg, Germany, 06188
Actively Recruiting
49
Investigational Site Number : 2760002
Münster, Germany, 48149
Actively Recruiting
50
Investigational Site Number : 2760001
Tübingen, Germany, 72076
Actively Recruiting
51
Investigational Site Number : 2760005
Wiesbaden, Germany, 65205
Actively Recruiting
52
Investigational Site Number : 2760003
Würzburg, Germany, 97080
Actively Recruiting
53
Investigational Site Number : 3480002
Budapest, Hungary, 1046
Actively Recruiting
54
Investigational Site Number : 3480004
Debrecen, Hungary, 4032
Actively Recruiting
55
Investigational Site Number : 3480003
Nyíregyháza, Hungary, 4400
Active, Not Recruiting
56
Investigational Site Number : 3480001
Pécs, Hungary, 7621
Actively Recruiting
57
Investigational Site Number : 3760007
Haifa, Israel, 3436212
Actively Recruiting
58
Investigational Site Number : 3760004
Kefar Sava, Israel, 4428164
Actively Recruiting
59
Investigational Site Number : 3760005
Petah Tikva, Israel, 4941492
Actively Recruiting
60
Investigational Site Number : 3760009
Tel Aviv, Israel, 6423906
Actively Recruiting
61
Azienda Ospedaliero-Universitaria di Ferrara-Site Number: 3800004
Cona, Ferrara, Italy, 44124
Actively Recruiting
62
Azienda Ospedaliera Universitaria Careggi-Site Number : 3800011
Florence, Firenze, Italy, 50134
Actively Recruiting
63
IRCCS Ospedale Policlinico San Martino-Site Number : 3800013
Genoa, Genova, Italy, 16132
Actively Recruiting
64
ASST Santi Paolo e Carlo-Presidio Ospedale San Paolo-Site Number : 3800006
Milan, Milano, Italy, 20142
Actively Recruiting
65
Azienda Ospedale - Università Padova-Site Number : 3800008
Padua, Padova, Italy, 35128
Actively Recruiting
66
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number: 3800002
Rome, Roma, Italy, 00168
Actively Recruiting
67
Ospedale Bellaria-Site Number: 3800009
Bologna, Italy, 40139
Actively Recruiting
68
Investigational Site Number : 3920010
Ichikawa, Chiba, Japan, 272-0143
Actively Recruiting
69
Investigational Site Number : 3920004
Narita, Chiba, Japan, 286-8520
Actively Recruiting
70
Investigational Site Number : 3920009
Isehara, Kanagawa, Japan, 259-1193
Actively Recruiting
71
Investigational Site Number : 3920002
Odawara, Kanagawa, Japan, 250-8558
Active, Not Recruiting
72
Investigational Site Number : 3920014
Yokohama, Kanagawa, Japan, 236-0037
Actively Recruiting
73
Investigational Site Number : 3920005
Suwa, Nagano, Japan, 392-0027
Actively Recruiting
74
Investigational Site Number : 3920012
Kusatsu, Shiga, Japan, 525-0066
Actively Recruiting
75
Investigational Site Number : 3920006
Fukui, Japan, 910-1104
Actively Recruiting
76
Investigational Site Number : 3920001
Fukuoka, Japan, 812-0053
Actively Recruiting
77
Investigational Site Number : 3920011
Hiroshima, Japan, 734-0004
Actively Recruiting
78
Investigational Site Number : 3920003
Kumamoto, Japan, 860-0814
Active, Not Recruiting
79
Investigational Site Number : 3920013
Niigata, Japan, 951-8520
Actively Recruiting
80
Investigational Site Number : 3920008
Tokyo, Japan, 153-8515
Actively Recruiting
81
Investigational Site Number : 4840004
Chihuahua City, Mexico, 31000
Actively Recruiting
82
Investigational Site Number : 4840003
Durango, Mexico, 34000
Actively Recruiting
83
Investigational Site Number : 5280004
Alkmaar, Netherlands, 1815 JD
Actively Recruiting
84
Investigational Site Number : 5280002
Leiderdorp, Netherlands, 2353 GA
Actively Recruiting
85
Investigational Site Number : 6160006
Krakow, Lesser Poland Voivodeship, Poland, 31-513
Actively Recruiting
86
Investigational Site Number : 6160001
Wroclaw, Lower Silesian Voivodeship, Poland, 53-149
Actively Recruiting
87
Investigational Site Number : 6160004
Wroclaw, Lower Silesian Voivodeship, Poland, 53-301
Actively Recruiting
88
Investigational Site Number : 6160005
Lublin, Lublin Voivodeship, Poland, 20-363
Actively Recruiting
89
Investigational Site Number : 6160002
Warsaw, Masovian Voivodeship, Poland, 00-909
Actively Recruiting
90
Investigational Site Number : 6160003
Bialystok, Podlaskie Voivodeship, Poland, 15-756
Actively Recruiting
91
Investigational Site Number : 6200003
Guimarães, Portugal, 4800-055
Actively Recruiting
92
Investigational Site Number : 6200004
Matosinhos Municipality, Portugal, 4464-513
Actively Recruiting
93
Investigational Site Number : 6200002
Porto, Portugal, 3814-501
Actively Recruiting
94
Investigational Site Number : 6200001
Santa Maria da Feira, Portugal, 4520-211
Actively Recruiting
95
Investigational Site Number : 4100005
Cheonan-Si, Chungcheongnam-do, South Korea, 31116
Actively Recruiting
96
Investigational Site Number : 4100009
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
97
Investigational Site Number : 4100008
Incheon, Incheon-gwangyeoksi, South Korea, 21565
Actively Recruiting
98
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea, 03080
Actively Recruiting
99
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea, 03722
Actively Recruiting
100
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea, 06351
Actively Recruiting
101
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea, 07061
Actively Recruiting
102
Investigational Site Number : 4100006
Seoul, South Korea, 02841
Actively Recruiting
103
Investigational Site Number : 7240007
Santiago de Compostela, A Coruña [La Coruña], Spain, 15702
Actively Recruiting
104
Investigational Site Number : 7240003
Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
Actively Recruiting
105
Investigational Site Number : 7240008
Barcelona, Barcelona [Barcelona], Spain, 08022
Actively Recruiting
106
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], Spain, 08036
Actively Recruiting
107
Investigational Site Number : 7240004
Jerez de la Frontera, Cádiz, Spain, 11407
Actively Recruiting
108
Investigational Site Number : 7240001
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
109
Investigational Site Number : 7240006
Seville, Sevilla, Spain, 41009
Actively Recruiting
110
Investigational Site Number : 7240009
Sabadell, Spain, 08208
Actively Recruiting
111
Investigational Site Number : 7240005
Zaragoza, Spain, 50009
Actively Recruiting
112
Investigational Site Number : 7520002
Lund, Sweden, 221 85
Actively Recruiting
113
Investigational Site Number : 7520001
Solna, Sweden, 171 64
Actively Recruiting
114
Investigational Site Number : 7520004
Stockholm, Sweden, 114 86
Actively Recruiting
115
Investigational Site Number : 7920003
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
116
Investigational Site Number : 7920001
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
117
Investigational Site Number : 7920002
Istanbul, Turkey (Türkiye), 34865
Actively Recruiting
118
Investigational Site Number : 8260002
London, London, City of, United Kingdom, NW1 2BU
Actively Recruiting
119
Investigational Site Number : 8260006
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
120
Investigational Site Number : 8260004
Bradford, United Kingdom, BD9 6RJ
Actively Recruiting
121
Investigational Site Number : 8260001
Newcastle upon Tyne, United Kingdom, NE7 7DN
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
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