AzTrials
AzTrials

Chronic Rhinosinusitis With Nasal PolypsPhase 3CEREN-1NCT06834347

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 121 sites in 21 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

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)… 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
231 participants
Where
121 sitesin 21 countries
Study dates
12 Feb 2025to 26 Mar 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.
Show all 12Show fewer
  • 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.
Show all 14Show fewer
  • 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

121 sites in 21 countries.

121 sites in 21 countries

United States21 sites

  • University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037

    Arcadia, California, 91006

  • Emory University School of Medicine- Grady Campus- Site Number : 8400047

    Atlanta, Georgia, 30303

  • Treasure Valley Medical Research- Site Number : 8400063

    Boise, Idaho, 83706

  • University of Chicago Medical Center- Site Number : 8400018

    Chicago, Illinois, 60637

  • TEN20 Clinical Research - Dallas- Site Number : 8400015

    Dallas, Texas, 75244

  • Deaconess Clinic Allergy East- Site Number : 8400056

    Evansville, Indiana, 47715

  • Northwell Health Physician Partners Rheumatology at Great Neck- Site Number : 8400028

    Great Neck, New York, 11021

  • Houston Methodist Hospital- Site Number : 8400054

    Houston, Texas, 77030

  • Sensa Health- Site Number : 8400038

    Los Angeles, California, 90006

  • ENT Associates of Texas - McKinne- Site Number : 8400062

    McKinney, Texas, 75070

  • Advanced Research Associates (ARA) Professionals- Site Number : 8400011

    Miami, Florida, 33176

  • Paradisus Med Research - Miami- Site Number : 8400009

    Miami, Florida, 33185

  • Newport Native MD- Site Number : 8400031

    Newport Beach, California, 92663

  • Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400046

    Norfolk, Virginia, 23510

  • Orlando ENT Associates - Orlando- Site Number : 8400008

    Orlando, Florida, 32807

  • Sacramento Ear Nose & Throat - Roseville- Site Number : 8400064

    Roseville, California, 95661

  • Alamo ENT Associates- Site Number : 8400065

    San Antonio, Texas, 78258

  • SSM Health Saint Louis University Hospital- Site Number : 8400005

    St Louis, Missouri, 63104

  • Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040

    Torrance, California, 90503

  • Orso Health - Torrance - Hawthorne Boulevard- Site Number : 8400035

    Torrance, California, 90505

  • Essential Medical Research- Site Number : 8400066

    Tulsa, Oklahoma, 74137

Other trials in United States

Japan13 sites

  • Investigational Site Number : 3920006

    Fukui, 910-1104

  • Investigational Site Number : 3920001

    Fukuoka, 812-0053

  • Investigational Site Number : 3920011

    Hiroshima, 734-0004

  • Investigational Site Number : 3920010

    Ichikawa, Chiba, 272-0143

  • Investigational Site Number : 3920009

    Isehara, Kanagawa, 259-1193

  • Investigational Site Number : 3920003

    Kumamoto, 860-0814

  • Investigational Site Number : 3920012

    Kusatsu, Shiga, 525-0066

  • Investigational Site Number : 3920004

    Narita, Chiba, 286-8520

  • Investigational Site Number : 3920013

    Niigata, 951-8520

  • Investigational Site Number : 3920002

    Odawara, Kanagawa, 250-8558

  • Investigational Site Number : 3920005

    Suwa, Nagano, 392-0027

  • Investigational Site Number : 3920008

    Tokyo, 153-8515

  • Investigational Site Number : 3920014

    Yokohama, Kanagawa, 236-0037

Other trials in Japan

Spain9 sites

  • Investigational Site Number : 7240008

    Barcelona, Barcelona [Barcelona], 08022

  • Investigational Site Number : 7240002

    Barcelona, Catalunya [Cataluña], 08036

  • Investigational Site Number : 7240004

    Jerez de la Frontera, Cádiz, 11407

  • Investigational Site Number : 7240001

    Majadahonda, Madrid, 28222

  • Investigational Site Number : 7240009

    Sabadell, 08208

  • Investigational Site Number : 7240007

    Santiago de Compostela, A Coruña [La Coruña], 15702

  • Investigational Site Number : 7240003

    Santiago de Compostela, A Coruña [La Coruña], 15706

  • Investigational Site Number : 7240006

    Seville, Sevilla, 41009

  • Investigational Site Number : 7240005

    Zaragoza, 50009

Other trials in Spain

Germany8 sites

  • Investigational Site Number : 2760004

    Berlin, 10117

  • Investigational Site Number : 2760007

    Frankfurt, 60318

  • Investigational Site Number : 2760008

    Hamburg, 22523

  • Investigational Site Number : 2760009

    Landsberg, 06188

  • Investigational Site Number : 2760002

    Münster, 48149

  • Investigational Site Number : 2760001

    Tübingen, 72076

  • Investigational Site Number : 2760005

    Wiesbaden, 65205

  • Investigational Site Number : 2760003

    Würzburg, 97080

Other trials in Germany

South Korea8 sites

  • Investigational Site Number : 4100005

    Cheonan-Si, Chungcheongnam-do, 31116

  • Investigational Site Number : 4100008

    Incheon, Incheon-gwangyeoksi, 21565

  • Investigational Site Number : 4100009

    Seongnam-si, Gyeonggi-do, 13620

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 06351

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 07061

  • Investigational Site Number : 4100006

    Seoul, 02841

Other trials in South Korea

Italy7 sites

  • Ospedale Bellaria-Site Number: 3800009

    Bologna, 40139

  • Azienda Ospedaliero-Universitaria di Ferrara-Site Number: 3800004

    Cona, Ferrara, 44124

  • Azienda Ospedaliera Universitaria Careggi-Site Number : 3800011

    Florence, Firenze, 50134

  • IRCCS Ospedale Policlinico San Martino-Site Number : 3800013

    Genoa, Genova, 16132

  • ASST Santi Paolo e Carlo-Presidio Ospedale San Paolo-Site Number : 3800006

    Milan, Milano, 20142

  • Azienda Ospedale - Università Padova-Site Number : 3800008

    Padua, Padova, 35128

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number: 3800002

    Rome, Roma, 00168

Other trials in Italy

Chile6 sites

  • Investigational Site Number : 1520004

    Lo Barnechea, Reg Metropolitana de Santiago, 7691236

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8207257

  • Investigational Site Number : 1520003

    Talca, Maule Region, 3465584

  • Investigational Site Number : 1520006

    Valdivia, Los Ríos Region, 5110683

  • Investigational Site Number : 1520005

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Poland6 sites

  • Investigational Site Number : 6160003

    Bialystok, Podlaskie Voivodeship, 15-756

  • Investigational Site Number : 6160006

    Krakow, Lesser Poland Voivodeship, 31-513

  • Investigational Site Number : 6160005

    Lublin, Lublin Voivodeship, 20-363

  • Investigational Site Number : 6160002

    Warsaw, Masovian Voivodeship, 00-909

  • Investigational Site Number : 6160001

    Wroclaw, Lower Silesian Voivodeship, 53-149

  • Investigational Site Number : 6160004

    Wroclaw, Lower Silesian Voivodeship, 53-301

Other trials in Poland

Argentina5 sites

  • Investigational Site Number : 0320001

    Buenos Aires, 1425

  • Investigational Site Number : 0320005

    Buenos Aires, 1638

  • Investigational Site Number : 0320002

    La Plata, Buenos Aires, 1900

  • Investigational Site Number : 0320003

    Mendoza, 5500

  • Investigational Site Number : 0320004

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Hungary4 sites

  • Investigational Site Number : 3480002

    Budapest, 1046

  • Investigational Site Number : 3480004

    Debrecen, 4032

  • Investigational Site Number : 3480003

    Nyíregyháza, 4400

  • Investigational Site Number : 3480001

    Pécs, 7621

Other trials in Hungary

Israel4 sites

  • Investigational Site Number : 3760007

    Haifa, 3436212

  • Investigational Site Number : 3760004

    Kefar Sava, 4428164

  • Investigational Site Number : 3760005

    Petah Tikva, 4941492

  • Investigational Site Number : 3760009

    Tel Aviv, 6423906

Other trials in Israel

Portugal4 sites

  • Investigational Site Number : 6200003

    Guimarães, 4800-055

  • Investigational Site Number : 6200004

    Matosinhos Municipality, 4464-513

  • Investigational Site Number : 6200002

    Porto, 3814-501

  • Investigational Site Number : 6200001

    Santa Maria da Feira, 4520-211

Other trials in Portugal

United Kingdom4 sites

  • Investigational Site Number : 8260004

    Bradford, BD9 6RJ

  • Investigational Site Number : 8260002

    London, London, City of, NW1 2BU

  • Investigational Site Number : 8260001

    Newcastle upon Tyne, NE7 7DN

  • Investigational Site Number : 8260006

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

Austria3 sites

  • Investigational Site Number : 0400005

    Graz, 8036

  • Investigational Site Number : 0400002

    Linz, 4010

  • Investigational Site Number : 0400001

    Vienna, 1090

Other trials in Austria

Brazil3 sites

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760002

    Ribeirão Preto, São Paulo, 14049-900

  • Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760005

    São José dos Campos, São Paulo, 12230-001

  • Hospital Israelita Albert Einstein- Site Number : 0760001

    São Paulo, 05651-901

Other trials in Brazil

Canada3 sites

  • Investigational Site Number : 1240005

    London, Ontario, N6A 4V2

  • Investigational Site Number : 1240002

    Montreal, Quebec, H4a 3j1

  • Investigational Site Number : 1240001

    Québec, Quebec, G1V 4G5

Other trials in Canada

Finland3 sites

  • Investigational Site Number : 2460004

    Helsinki, 00029

  • Investigational Site Number : 2460003

    Helsinki, 00130

  • Investigational Site Number : 2460002

    Kuopio, 70210

Other trials in Finland

Sweden3 sites

  • Investigational Site Number : 7520002

    Lund, 221 85

  • Investigational Site Number : 7520001

    Solna, 171 64

  • Investigational Site Number : 7520004

    Stockholm, 114 86

Other trials in Sweden

Turkey (Türkiye)3 sites

  • Investigational Site Number : 7920003

    Ankara, 06230

  • Investigational Site Number : 7920001

    Istanbul, 34093

  • Investigational Site Number : 7920002

    Istanbul, 34865

Other trials in Turkey (Türkiye)

Mexico2 sites

  • Investigational Site Number : 4840004

    Chihuahua City, 31000

  • Investigational Site Number : 4840003

    Durango, 34000

Other trials in Mexico

Netherlands2 sites

  • Investigational Site Number : 5280004

    Alkmaar, 1815 JD

  • Investigational Site Number : 5280002

    Leiderdorp, 2353 GA

Other trials in Netherlands

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

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.
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 NCT06834347
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 start12 Feb 2025
  3. Primary completion23 Sep 2026
  4. Study completion26 Mar 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
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06834347
Sponsor's protocol ID
EFC18418
Other IDs
2024-516814-39, U1111-1306-4858
Acronym
CEREN-1
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 121 sites in 21 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 121 sites in United States, Japan, Spain, Germany, South Korea and 16 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 NCT06834347.

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 uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in