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Chronic Rhinosinusitis With Nasal PolypsPhase 3CEREN-2NCT06834360

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

A Phase 3 study testing Itepekimab (SAR440340) and Mometasone furoate nasal spray (MFNS) in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 111 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Rhinosinusitis With Nasal Polyps
What is being tested?
Itepekimab (SAR440340) and Mometasone furoate nasal spray (MFNS)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
111 sitesin 23 countries
Study dates
6 Feb 2025to 17 Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be 18 years of age or older.
  • Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening
  • Participants must have at least one of the following features:
  • Prior sinonasal surgery for nasal polyps (NP).
  • Worsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 1 year before screening (Visit 1).
  • An endoscopic bilateral Nasal Polyp Score (NPS) of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity) at screening and randomization.
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  • Ongoing symptoms (for at least 12 weeks before Visit 1) of:
  • Nasal congestion/blockade/obstruction with moderate or severe (symptom severity score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 in the week before randomization (Visit 2), AND
  • At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior).
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
  • Is not a women of childbearing potential (WOCBP), OR
  • Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study (at a minimum until 20 weeks after the last dose of study intervention).

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding those with asthma and aspirin-exacerbated respiratory disease (AERD) which may be included in the study), gastrointestinal, cardiovascular, cerebrovascular, or other significant medical illness or disorder, which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study.
  • Participants who are currently smoking tobacco and/or vaping, or participants in whom smoking/vaping cessation has occurred <6 months prior to Screening (Visit 1). Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco.
  • Participants meet any contraindications for mometasone furoate nasal spray (MFNS) such as hypersensitivity to MFNS or any of its components; or participants with uncontrolled opportunistic infections.
  • Participants with a history of a severe systemic hypersensitivity reaction to a mAb.
  • Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint.
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  • Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc).
  • Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year.
  • History of concomitant lung disease (other than asthma, eg, COPD, interstitial lung disease) which in the opinion of the Investigator could interfere with performance and interpretation of spirometry.
  • Participants treated with intranasal corticosteroid(s) (INCS) (MFNS is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM during the screening period. In Japan and China INCS other than MFNS are permitted.
  • Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1.
  • Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).
  • Known allergy to itepekimab or its excipients, or any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in this study.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

111 sites in 23 countries.

111 sites in 23 countries

United States15 sites

  • Johns Hopkins Hospital- Site Number : 8400017

    Baltimore, Maryland, 21287

  • Excel ENT of Alabama- Site Number : 8400052

    Birmingham, Alabama, 35244

  • University of Illinois at Chicago- Site Number : 8400003

    Chicago, Illinois, 60607

  • University of Cincinnati Medical Center- Site Number : 8400022

    Cincinnati, Ohio, 45219

  • Ear and Sinus Institute- Site Number : 8400048

    Fort Worth, Texas, 76104

  • Spartanburg-Greer ENT & Allergy- Site Number : 8400039

    Greer, South Carolina, 29650

  • University of Florida - Jacksonville- Site Number : 8400053

    Jacksonville, Florida, 32209

  • Velocity Clinical Research - San Diego- Site Number : 8400041

    La Mesa, California, 91942

  • Velocity Clinical Research - Lafayette- Site Number : 8400026

    Lafayette, Louisiana, 70508

  • Cedars-Sinai Medical Center- Site Number : 8400030

    Los Angeles, California, 90048

  • Advanced ENT & Allergy - Louisville- Site Number : 8400007

    Louisville, Kentucky, 40220

  • One Of A Kind Clinical Research Center- Site Number : 8400034

    Napa, California, 94558

  • Advanced Research Institute - New Port Richey- Site Number : 8400014

    New Port Richey, Florida, 34653

  • Allergy, Asthma and Clinical Research- Site Number : 8400002

    Oklahoma City, Oklahoma, 73120

  • Thomas Jefferson University Hospital- Site Number : 8400044

    Philadelphia, Pennsylvania, 19107

Other trials in United States

China15 sites

  • Investigational Site Number : 1560020

    Baotou, 014040

  • Investigational Site Number : 1560001

    Beijing, 100730

  • Investigational Site Number : 1560004

    Chengdu, 610017

  • Investigational Site Number : 1560025

    Chongqing, 400016

  • Investigational Site Number : 1560019

    Hangzhou, 310003

  • Investigational Site Number : 1560002

    Jinan, 250022

  • Investigational Site Number : 1560012

    Jingzhou, 434020

  • Investigational Site Number : 1560021

    Nanning, 530021

  • Investigational Site Number : 1560006

    Shenyang, 110004

  • Investigational Site Number : 1560024

    Suzhou, 215006

  • Investigational Site Number : 1560017

    Taiyuan, 030001

  • Investigational Site Number : 1560023

    Taiyuan, 030001

  • Investigational Site Number : 1560014

    Wuhan, 430060

  • Investigational Site Number : 1560003

    Yantai, 264001

  • Investigational Site Number : 1560009

    Zibo, 255036

Other trials in China

Canada6 sites

  • Investigational Site Number : 1240019

    Burlington, Ontario, L7R 3P9

  • Investigational Site Number : 1240015

    Cambridge, Ontario, N1R 8L4

  • Investigational Site Number : 1240014

    Ottawa, Ontario, K1G 6C6

  • Investigational Site Number : 1240003

    Québec, Quebec, G1V 4W2

  • Investigational Site Number : 1240012

    Québec, Quebec, G2J 0C4

  • Investigational Site Number : 1240017

    Vancouver, British Columbia, V6A 2W1

Other trials in Canada

France6 sites

  • Investigational Site Number : 2500011

    Bordeaux, 33076

  • Investigational Site Number : 2500004

    Marseille, 13005

  • Investigational Site Number : 2500001

    Nantes, 44093

  • Investigational Site Number : 2500010

    Poitiers, 86021

  • Investigational Site Number : 2500014

    Pontoise, 95300

  • Investigational Site Number : 2500007

    Toulouse, 31059

Other trials in France

Germany6 sites

  • Investigational Site Number : 2760006

    Dresden, 01139

  • Investigational Site Number : 2760001

    Dresden, 01307

  • Investigational Site Number : 2760005

    Hamburg, 20246

  • Investigational Site Number : 2760002

    Leipzig, 04103

  • Investigational Site Number : 2760007

    Mainz, 55131

  • Investigational Site Number : 2760008

    Villingen-Schwenningen, 78052

Other trials in Germany

Spain6 sites

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08003

  • Investigational Site Number : 7240004

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907

  • Investigational Site Number : 7240010

    Madrid, 28034

  • Investigational Site Number : 7240012

    Madrid, 28040

  • Investigational Site Number : 7240008

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240002

    Santander, Cantabria, 39008

Other trials in Spain

Argentina5 sites

  • Investigational Site Number : 0320002

    Buenos Aires, 1121

  • Investigational Site Number : 0320001

    Buenos Aires, 1414

  • Investigational Site Number : 0320004

    Corrientes, 3400

  • Investigational Site Number : 0320003

    Mendoza, 5500

  • Investigational Site Number : 0320005

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Czechia5 sites

  • Investigational Site Number : 2030002

    Hradec Králové, 500 05

  • Investigational Site Number : 2030003

    Pardubice, 532 03

  • Investigational Site Number : 2030005

    Pilsen, 305 99

  • Investigational Site Number : 2030004

    Prague, 100 34

  • Investigational Site Number : 2030001

    Prague, 150 06

Other trials in Czechia

Belgium4 sites

  • Investigational Site Number : 0560006

    Alken, 3570

  • Investigational Site Number : 0560004

    Gesves, Namur, 5340

  • Investigational Site Number : 0560002

    Ghent, 9000

  • Investigational Site Number : 0560001

    Leuven, 3000

Other trials in Belgium

Brazil4 sites

  • Private Practice - Dr. Nelson Rosário- Site Number : 0760001

    Curitiba, Paraná, 80810-100

  • Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002

    Marília, São Paulo, 17504-072

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760005

    São José do Rio Preto, São Paulo, 15090-000

  • Clinica de Alergia Martti Antila- Site Number : 0760003

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Chile4 sites

  • Investigational Site Number : 1520001

    Concepción, Biobio, 4070094

  • Investigational Site Number : 1520002

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500505

  • Investigational Site Number : 1520004

    Talcahuano, Biobio, 2687000

Other trials in Chile

Israel4 sites

  • Investigational Site Number : 3760003

    Haifa, 3104802

  • Investigational Site Number : 3760004

    Jerusalem, 9112001

  • Investigational Site Number : 3760001

    Nahariya, 2210001

  • Investigational Site Number : 3760002

    Rehovot, 7610001

Other trials in Israel

Mexico4 sites

  • Investigational Site Number : 4840007

    Chihuahua City, 31217

  • Investigational Site Number : 4840001

    Guadalajara, Jalisco, 44100

  • Investigational Site Number : 4840008

    Monterrey, Nuevo León, 64718

  • Investigational Site Number : 4840002

    Veracruz, 91900

Other trials in Mexico

Poland4 sites

  • Investigational Site Number : 6160001

    Bielsko-Biala, Silesian Voivodeship, 43-300

  • Investigational Site Number : 6160002

    Lodz, Lódzkie, 90-302

  • Investigational Site Number : 6160004

    Poznan, Greater Poland Voivodeship, 60-693

  • Investigational Site Number : 6160005

    Wroclaw, Lower Silesian Voivodeship, 50-750

Other trials in Poland

Australia3 sites

  • Investigational Site Number : 0360003

    Bella Vista, New South Wales, 2153

  • Investigational Site Number : 0360002

    Brisbane, Queensland, 4029

  • Investigational Site Number : 0360001

    Spearwood, Western Australia, 6163

Other trials in Australia

Denmark3 sites

  • Investigational Site Number : 2080001

    Aarhus, 8200

  • Investigational Site Number : 2080004

    Copenhagen, 2100

  • Investigational Site Number : 2080002

    Køge, 4600

Other trials in Denmark

Italy3 sites

  • Investigational Site Number : 3800003

    Catania, 95123

  • Investigational Site Number : 3800001

    Milan, Milano, 20132

  • Investigational Site Number : 3800005

    Naples, Napoli, 80131

Other trials in Italy

Romania3 sites

  • Investigational Site Number : 6420003

    Brasov, 500091

  • Investigational Site Number : 6420002

    Brasov, 500283

  • Investigational Site Number : 6420001

    Bucharest, 022328

Other trials in Romania

Turkey (Türkiye)3 sites

  • Investigational Site Number : 7920003

    Ankara, 06230

  • Investigational Site Number : 7920001

    Bursa, 16059

  • Investigational Site Number : 7920002

    Istanbul, 34360

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Investigational Site Number : 8260001

    London, London, City of, W2 1NY

  • Investigational Site Number : 8260003

    Taunton, Somerset, TA1 5DA

  • Investigational Site Number : 8260002

    Wigan, Lancashire, Wn6 9ep

Other trials in United Kingdom

Hungary2 sites

  • Investigational Site Number : 3480005

    Budapest, 1026

  • Investigational Site Number : 3480001

    Szeged, 6720

Other trials in Hungary

Netherlands2 sites

  • Investigational Site Number : 5280002

    Amsterdam, 1081 HV

  • Investigational Site Number : 5280001

    Utrecht, 3584 CX

Other trials in Netherlands

Japan1 site

  • Investigational Site Number : 2500005

    Toyama, 939-2716

Other trials in Japan

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

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.
Being tested
Itepekimab (SAR440340), Placebo, Mometasone furoate nasal spray (MFNS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Itepekimab (SAR440340)Drug

    Also called REGN3500

    Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

  • Mometasone furoate nasal spray (MFNS)Drug

    Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray

Study groups in NCT06834360
Study groupRoleWhat they receive
Itepekimab high doseExperimentalSubcutaneous (SC) administration of Itepekimab high dose for 52 weeks
Receives: Drug: Itepekimab (SAR440340); Drug: Mometasone furoate nasal spray (MFNS)
Itepekimab low doseExperimentalSC administration of Itepekimab low dose for 52 weeks
Receives: Drug: Itepekimab (SAR440340); Drug: Placebo; Drug: Mometasone furoate nasal spray (MFNS)
PlaceboPlacebo comparatorSC administration of matching placebo for 52 weeks
Receives: Drug: Placebo; Drug: Mometasone furoate nasal spray (MFNS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the endoscopic NPS

    The Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps).

    Measured: Baseline to Week 24

  2. Change from baseline in the NCS

    The Nasal Congestion Score (NCS) is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms.

    Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.

    Measured: Baseline to Week 24

Secondary outcomes (22)

  1. Change from baseline in endoscopic NPS

    The NPS is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps).

    Measured: Baseline to Week 52

  2. Change from baseline in NCS

    The NCS is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms.

    Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.

    Measured: Baseline to Week 52

  3. Change from baseline in opacification of sinuses assessed by Computed Tomography (CT) scan using the LMK score

    The Lund-Mackay (LMK) system is based on localization with points given for degree of opacification: 0 = normal, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The osteomeatal complex is graded as 0 = not occluded, or 2 = occluded, deriving a maximum score of 12 per side. The total score is the sum of scores from each side and ranges from 0 (normal) to 24 (total opacification).

    Measured: Baseline to Week 24

  4. Change from baseline in the TSS (nasal congestion/obstruction, anterior/posterior rhinorrhea, and loss of sense of smell)

    The CRSwNP Total Symptom Score (TSS) is a composite score derived from nasal congestion (NC)/obstruction, anterior/posterior rhinorrhea, and loss of smell. The total score ranges from 0 to 9 with higher scores on TSS indicating greater overall symptom severity.

    Measured: Baseline to Weeks 24 and 52

  5. Change from baseline in loss of smell severity score using the daily CRSwNP sinonasal symptom eDiary, and UPSIT score

    The CRSwNP sinonasal symptom diary is designed to assess the severity of chronic rhinosinusitis (CRS) sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity.

    The University of Pennsylvania Smell Identification Test (UPSIT) test is a rapid and easy-to-administer method to quantitatively assess human olfactory function. The total score ranges from 0 (anosmia) to 40 (normosmia).

    Measured: Baseline to Weeks 24 and 52

  6. Change from baseline in SNOT-22 total score

    The Sino-Nasal Outcome Test-22-Items (SNOT-22) is a patient-reported outcome questionnaire designed to assess the impact of CRS on patient's Health-Related Quality of Life (HRQoL). It has 22 items covering five domains: Nasal, Ear/Facial, Sleep, Function, and Emotion. A global score ranging from 0 to 110 with higher score indicating greater rhinosinusitis related health burden.

    Measured: Baseline to Weeks 24 and 52

  7. Change from baseline in PROMIS SD-SF-8b scores

    The Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 8b (SD-SF-8b) is a generic 8-item sleep disturbance assessment that evaluates difficulties with falling asleep, staying asleep, and getting enough sleep; and perceptions on the quality and satisfaction of sleep. Scores are calculated with a conversion of the raw score (score range 8 to 40) into a standardized T-score with the mean of the 50 and SD of 10, where higher scores indicate more disturbed sleep.

    Measured: Baseline to Weeks 24 and 52

  8. Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for CRS

    Measured: Baseline up to Week 52

  9. Annualized rate of SCS course or surgery for CRS

    Measured: Baseline up to Week 52

  10. Time to first either SCS or surgery for CRS

    Measured: Baseline through Week 52

  11. Change from baseline in pre-BD FEV1 (in mL) in participants with co-morbid asthma

    Pre-BD FEV1: pre-bronchodilator forced expiratory volume in 1 second

    Measured: Baseline to Weeks 24 and 52

  12. Change from baseline in ACQ-5 score in participants with co-morbid asthma

    The Asthma Control Questionnaire (ACQ) is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has 5 questions on the asthma symptoms. The global score is the mean of the item responses and ranges from 0 and 6 with higher score indicating lower asthma control.

    Measured: Baseline to Weeks 24 and 52

  13. Change from the baseline in NPS and NCS in the subgroup of patients with aspirin-exacerbated respiratory disease (AERD)

    Measured: Baseline to Weeks 24 and 52

  14. Proportion of participants with AERD requiring SCS or surgery for CRS

    Measured: Baseline up to Week 52

  15. Annualized rate of SCS course or surgery for CRS in participants with AERD

    Measured: Baseline up to Week 52

  16. Time to first either SCS or surgery for CRS in participants with AERD

    Measured: Baseline through Week 52

  17. Change from baseline in pre-BD FEV1 (in ml) in participants with AERD

    Pre-BD FEV1: pre-bronchodilator forced expiratory volume in 1 second

    Measured: Baseline to Weeks 24 and 52

  18. Proportion of NPS responders (defined as participants with improvement by at least 1 point in NPS)

    Measured: Weeks 24 and 52

  19. Proportion of NPS responders (defined as participants with improvement by at least 2 points in NPS)

    Measured: Weeks 24 and 52

  20. Incidence of treatment-emergent adverse Events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events of special interest (TEAESIs) and TEAEs leading to treatment discontinuation

    Measured: Baseline to End of Study (EOS) (Week 72)

  21. Itepekimab concentration in serum

    Measured: Baseline to EOS (Week 72)

  22. Incidence of treatment-emergent anti-itepekimab antibody (ADA) responses

    Measured: Baseline to EOS (Week 72)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start6 Feb 2025
  3. Primary completion24 Sep 2026
  4. Study completion17 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06834360
Sponsor's protocol ID
EFC18419
Other IDs
2024-516815-26, U1111-1306-6544
Acronym
CEREN-2
Status last verified
Oct 2026
First submitted
14 Feb 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Itepekimab (SAR440340) and Mometasone furoate nasal spray (MFNS) in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 111 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United States, China, Canada, France, Germany and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the endoscopic NPS (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06834360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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