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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

Enrolling by Invitation
PHASE3Ages 18+InterventionalTreatment
Sanofi
~380 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Itepekimab (SAR440340)Placebo

At a glance

Recruiting sites
0 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Baseline to EOS (Week 72)

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Explore related trials

Chronic rhinosinusitis with multiple nasal polyps

Where it's being run

23 sites across 13 states
China6
Quebec3
Reg Metropolitana de Santiago3
Seoul-teukbyeolsi2
California1
Oklahoma1
Western Australia1
Biobio1

Study leadership

  • Clinical Sciences & Operations · STUDY_DIRECTOR · Sanofi

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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 discontinuationBaseline to EOS (Week 72)

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