AzTrials
AzTrials

Chronic Rhinosinusitis With Nasal PolypsPhase 3CEREN-4NCT07484230

A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese 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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a randomized, multicenter, double-blind, Phase 3 study with 2 parallel groups. The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different dosing regimens of itepekimab monotherapy in Japanese participants aged 18 years or older with chronic rhinosinusitis with nasal polyp(s)… 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
0 participants
Where
No sites listed yet
Study dates
8 May 2026to 10 Oct 2028
Phase
Phase 3
Are there results?
None posted in the registry

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 CRSwNP for at least 1 year.
  • Participants must have at least one of the following features:
  • Prior sinonasal surgery for NP.
  • Worsening symptoms of CRS requiring treatment with SCS within the prior 1 year.
  • An endoscopic bilateral NPS of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity).
Show all 13Show fewer
  • Ongoing symptoms (for at least 12 weeks before Visit 1) of:
  • Nasal congestion/blockade/obstruction with moderate or severe symptom (score of 2 or 3), AND
  • At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior).
  • Not currently on and have not been receiving INCS for at least one month.
  • 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 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. Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco.
  • Participants with a history of a severe systemic hypersensitivity reaction to a mAb.
  • Participants with conditions/concomitant diseases making them non-evaluable or for the primary efficacy endpoint.
  • Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc).
Show all 12Show fewer
  • Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year.
  • Participants treated with intranasal corticosteroid(s) (INCS), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM one month prior during the screening period.
  • 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.

About this study

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

This is a randomized, multicenter, double-blind, Phase 3 study with 2 parallel groups. The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different dosing regimens of itepekimab monotherapy in Japanese participants aged 18 years or older with chronic rhinosinusitis with nasal polyp(s) (CRSwNP) who are not adequately controlled despite previous surgery and/or treatment with systemic corticosteroid(s) (SCS).

The total study duration par participant is approximately 76 week, including:

  • A screening period for up to 4 weeks.
  • A randomized study intervention period for up to 52 weeks
  • A post-intervention safety follow-up for up to 20 weeks
  • The number of visits will be 9 site visits and 20 phone/home visits
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 NCT07484230
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. 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

Secondary outcomes (9)

  1. 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

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

    Measured: Week 24 and Week 52

  3. 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

  4. 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

  5. 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

  6. Change from baseline in loss of smell severity score using the daily CRSwNP sinonasal symptom eDiary

    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.

    Measured: Baseline to Weeks 24 and 52

  7. Incidence of TEAEs, TESAEs, TEAESIs and TEAEs leading to treatment discontinuation

    Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events of special interest (TEAESIs)

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

  8. Itepekimab concentration in serum

    Measured: Baseline to EOS (Week 72)

  9. Incidence of treatment-emergent antidrug 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 posted20 Mar 2026
  2. Study start8 May 2026 (estimated)
  3. Primary completion20 Oct 2027 (estimated)
  4. Study completion10 Oct 2028 (estimated)

Why it stopped: Sponsor decision. Not related to safety concern.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07484230
Sponsor's protocol ID
EFC21029
Other IDs
U1111-1322-6073
Acronym
CEREN-4
Status last verified
Aug 2026
First submitted
16 Mar 2026
Last updated
13 Aug 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.

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 13 inclusion and 12 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: withdrawn, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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). 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 NCT07484230.

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 Aug 2026.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in