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Enrolling by Invitation

NCT Number: NCT07424144

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

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.

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.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number : 0362001, Spearwood, Western Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

Itepekimab (SAR440340)

Drug

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

Other names: REGN3500

Placebo

Drug

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

Primary outcomes

  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

    Time frame: Baseline to EOS (Week 72)

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

Secondary outcomes

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

    Time frame: Baseline to Week 52

    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).

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

    Time frame: Baseline to EOS (Week 72)

    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.

  3. Functional itepekimab concentration in serum

    Time frame: Baseline to EOS (Week 72)

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

    Time frame: Baseline to EOS (Week 72)

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

    Time frame: Baseline up to Week 52

  6. Annualized rate of SCS course or surgery for CRS

    Time frame: Baseline up to Week 52

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: CEREN-3

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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