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New drug itepekimab tested for Long-Term safety in nasal polyp patients

NCT ID NCT07424144

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This Phase 3 study tests the long-term safety of itepekimab, an injected drug, in 380 adults with chronic sinusitis and nasal polyps that are hard to control. Participants previously completed a one-year study on itepekimab. The trial lasts up to 72 weeks and also checks if the drug continues to work over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
itepekimab
What this could lead to
If successful, this could confirm itepekimab as a safe long-term treatment option for people with hard-to-control nasal polyps and sinusitis.
What could go wrong
This is an extension study focused on safety, not a new efficacy trial. It may not show major new benefits, and side effects could still emerge over longer use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

59 people

The number who actually took part.

Started

Mar 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis with nasal polyps

Contacts and locations

Locations

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

    Oklahoma City, Oklahoma, 73120, United States

  • Investigational Site Number : 0362001

    Spearwood, Western Australia, 6163, Australia

  • Investigational Site Number : 1241001

    Québec, Quebec, G1V 4G5, Canada

  • Investigational Site Number : 1242003

    Québec, Quebec, G1V 4W2, Canada

  • Investigational Site Number : 1242012

    Québec, Quebec, G2J 0C4, Canada

  • Investigational Site Number : 1521001

    Santiago, Reg Metropolitana de Santiago, 8207257, Chile

  • Investigational Site Number : 1521002

    Santiago, Reg Metropolitana de Santiago, 7500692, Chile

  • Investigational Site Number : 1521003

    Talca, Maule Region, 3465584, Chile

  • Investigational Site Number : 1522001

    Concepción, Biobio, 4070094, Chile

  • Investigational Site Number : 1522003

    Santiago, Reg Metropolitana de Santiago, 7500505, Chile

  • Investigational Site Number : 1562001

    Beijing, 100730, China

  • Investigational Site Number : 1562004

    Chengdu, 610017, China

  • Investigational Site Number : 1562006

    Shenyang, 110004, China

  • Investigational Site Number : 1562008

    Jingzhou, 434020, China

  • Investigational Site Number : 1562010

    Taiyuan, 030001, China

  • Investigational Site Number : 1562012

    Baotou, 014040, China

  • Investigational Site Number : 2032001

    Prague, 150 06, Czechia

  • Investigational Site Number : 3481002

    Budapest, 1046, Hungary

  • Investigational Site Number : 4101001

    Seoul, Seoul-teukbyeolsi, 07061, South Korea

  • Investigational Site Number : 4101003

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 8261004

    Bradford, BD9 6RJ, United Kingdom

  • Investigational Site Number : 8262002

    Wigan, Lancashire, Wn6 9ep, United Kingdom

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

    La Mesa, California, 91942, United States

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