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Chronic Rhinosinusitis With Nasal PolypsPhase 3CEREN-3NCT07424144

An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps

A Phase 3 study testing Itepekimab (SAR440340) in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 46 sites in 13 countries.

Active, not recruiting

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

Official record
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Trial summary

This is a double-blind, parallel-group, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. 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)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
46 sitesin 13 countries
Study dates
12 Mar 2026to 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 with CRSwNP who completed the 52-weeks intervention period in a previous itepekimab CRSwNP Phase 3 clinical study (ie, EFC18418 or EFC18419) and for which an EOT visit occurred no later than 5 days before the enrollment visit of this study.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • Is not a women of childbearing potential (WOCBP), OR
  • Is a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 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:
  • Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin.
  • Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status.
  • Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study.
  • Any other situation that led to a permanent premature IMP discontinuation in parent trials.
  • 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

46 sites in 13 countries.

46 sites in 13 countries

China11 sites

  • Investigational Site Number : 1562012

    Baotou, 014040

  • Investigational Site Number : 1562001

    Beijing, 100730

  • Investigational Site Number : 1562004

    Chengdu, 610017

  • Investigational Site Number : 1562002

    Jinan, 250022

  • Investigational Site Number : 1562008

    Jingzhou, 434020

  • Investigational Site Number : 1562013

    Nanning, 530021

  • Investigational Site Number : 1562006

    Shenyang, 110004

  • Investigational Site Number : 1562010

    Taiyuan, 030001

  • Investigational Site Number : 1562014

    Taiyuan, 030001

  • Investigational Site Number : 1562009

    Wuhan, 430060

  • Investigational Site Number : 1562007

    Zibo, 255036

Other trials in China

Chile6 sites

  • Investigational Site Number : 1522001

    Concepción, Biobio, 4070094

  • Investigational Site Number : 1521004

    Lo Barnechea, Reg Metropolitana de Santiago, 7691236

  • Investigational Site Number : 1521001

    Puente Alto, Reg Metropolitana de Santiago, 8207257

  • Investigational Site Number : 1522003

    Santiago, Reg Metropolitana de Santiago, 7500505

  • Investigational Site Number : 1521002

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1521003

    Talca, Maule Region, 3465584

Other trials in Chile

Czechia4 sites

  • Investigational Site Number : 2032002

    Hradec Králové, 500 05

  • Investigational Site Number : 2032003

    Pardubice, 532 03

  • Investigational Site Number : 2032004

    Prague, 100 34

  • Investigational Site Number : 2032001

    Prague, 150 06

Other trials in Czechia

United States3 sites

  • Ear and Sinus Institute- Site Number : 8402048

    Fort Worth, Texas, 76104

  • Velocity Clinical Research - San Diego- Site Number : 8402041

    La Mesa, California, 91942

  • Allergy, Asthma and Clinical Research- Site Number : 8402002

    Oklahoma City, Oklahoma, 73120

Other trials in United States

Argentina3 sites

  • Investigational Site Number : 0321001

    Buenos Aires, 1425

  • Investigational Site Number : 0321003

    Mendoza, 5500

  • Investigational Site Number : 0321004

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Canada3 sites

  • Investigational Site Number : 1241001

    Québec, Quebec, G1V 4G5

  • Investigational Site Number : 1242003

    Québec, Quebec, G1V 4W2

  • Investigational Site Number : 1242012

    Québec, Quebec, G2J 0C4

Other trials in Canada

Hungary3 sites

  • Investigational Site Number : 3482005

    Budapest, 1026

  • Investigational Site Number : 3481002

    Budapest, 1046

  • Investigational Site Number : 3481001

    Pécs, 7621

Other trials in Hungary

Poland3 sites

  • Investigational Site Number : 6162001

    Bielsko-Biala, Silesian Voivodeship, 43-309

  • Investigational Site Number : 6162004

    Poznan, Greater Poland Voivodeship, 60-693

  • Investigational Site Number : 6161004

    Wroclaw, Lower Silesian Voivodeship, 53-301

Other trials in Poland

South Korea3 sites

  • Investigational Site Number : 4101003

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4101002

    Seoul, Seoul-teukbyeolsi, 06351

  • Investigational Site Number : 4101001

    Seoul, Seoul-teukbyeolsi, 07061

Other trials in South Korea

United Kingdom3 sites

  • Investigational Site Number : 8261004

    Bradford, BD9 6DA

  • Investigational Site Number : 8262001

    London, London, City of, W2 1NY

  • Investigational Site Number : 8262002

    Wigan, Lancashire, Wn6 9ep

Other trials in United Kingdom

Portugal2 sites

  • Investigational Site Number : 6201003

    Guimarães, 4800-055

  • Investigational Site Number : 6201002

    Porto, 3814-501

Other trials in Portugal

Australia1 site

  • Investigational Site Number : 0362001

    Spearwood, Western Australia, 6163

Other trials in Australia

Austria1 site

  • Investigational Site Number : 0401005

    Graz, 8036

Other trials in Austria

About this study

Official title: A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Participated in Either EFC18418 or EFC18419 Clinical Studies

This is a double-blind, parallel-group, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments.

The primary purpose of this study is to evaluate safety and tolerability of both new or continued treatment with itepekimab 300 mg SC high dose or itepekimab 300 mg SC low dose in participants with CRSwNP having completed the intervention period of the clinical studies EFC18418 or EFC18419. A secondary purpose of this study is to provide efficacy outcomes beyond the intervention period of the parent trials EFC18418 and EFC18419.

Read more

Study details include:

  • The study duration will be up to 72 weeks.
  • The intervention duration will be 52 weeks.
  • A follow-up period of 20 weeks will be conducted.
  • The number of visits will be 8 and the number of phone contacts will be 4.
Being tested
Itepekimab (SAR440340), Placebo

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

Study groups in NCT07424144
Study groupRoleWhat they receive
Itepekimab high doseExperimentalSubcutaneous (SC) administration of Itepekimab high dose for 52 weeks
Receives: Drug: Itepekimab (SAR440340)
Itepekimab low doseExperimentalSC administration of Itepekimab low dose for 52 weeks
Receives: Drug: Itepekimab (SAR440340); Drug: Placebo

What is being measured

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

  1. Incidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), AEs leading to death, and AEs leading to permanent treatment discontinuation

    All AEs (serious or nonserious) will be collected from the signing of the ICF until end of study (EOS) visit

    Measured: Baseline to EOS (Week 72)

Secondary outcomes (6)

  1. Change from baseline of the parent studies (EFC18418, EFC18419) in 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 52

  2. Change from baseline of the parent studies (EFC18418, EFC18419) in NCS

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

    Measured: Baseline to EOS (Week 72)

  3. Functional itepekimab concentration in serum

    Measured: Baseline to EOS (Week 72)

  4. Incidence of treatment-emergent anti-drug antibody (ADA) responses

    Measured: Baseline to EOS (Week 72)

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

    Measured: Baseline up to Week 52

  6. Annualized rate of SCS course or surgery for CRS

    Measured: Baseline up to Week 52

Timeline

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

  1. First posted20 Feb 2026
  2. Study start12 Mar 2026
  3. Primary completion17 Feb 2027 (estimated)
  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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07424144
Sponsor's protocol ID
LTS18420
Other IDs
2025-522983-33, U1111-1320-4430, 2025
Acronym
CEREN-3
Status last verified
Oct 2026
First submitted
13 Feb 2026
Last updated
13 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) in people with Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 46 sites in 13 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 4 inclusion and 6 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 13 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 46 sites in China, Chile, Czechia, United States, Argentina and 8 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. 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?

Incidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), AEs leading to death, and AEs leading to permanent treatment discontinuation (time frame: Baseline to EOS (Week 72)). 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 NCT07424144.

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 13 Oct 2026.

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