An extension study to investigate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-05-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2025-522983-33-00

WHO UTN

U1111-1320-4430

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Therapy

Evaluate the long-term safety and tolerability of itepekimab in participants with inadequately controlled CRSwNP who completed treatment in previous itepekimab CRSwNP clinical studies (EFC18418, EFC18419)

Secondary objectives 4

1. Evaluate the long-term efficacy of itepekimab on nasal polyps size and symptoms of nasal congestion in participants with CRSwNP who completed treatment in previous itepekimab CRSwNP clinical studies (EFC18418, EFC18419)
2. Evaluate the PK profile of itepekimab in participants with inadequately controlled CRSwNP who completed treatment in previous itepekimab CRSwNP clinical studies (EFC18418, EFC18419)
3. Evaluate immunogenicity to itepekimab in participants with inadequately controlled CRSwNP who completed treatment in previous itepekimab CRSwNP clinical studies (EFC18418, EFC18419)
4. To evaluate the ability of itepekimab to reduce the risk of worsening/acute sinusitis requiring treatment with SCS or sinus surgery

Conditions and MedDRA coding

Chronic rhinosinusitis with nasal polyps

Regulatory references

Plan to share IPD

Yes

IPD plan description

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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.
2. 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 4

1. Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin.
2. Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status.
3. Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study.
4. Any other situation that led to a permanent premature IMP discontinuation in parent trials.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 6

1. Change from baseline of the parent studies (EFC18418, EFC18419) in endoscopic NPS
2. Change from baseline of the parent studies (EFC18418, EFC18419) in NCS
3. Functional itepekimab concentration in serum
4. Incidence of treatment-emergent anti-drug antibody (ADA) responses
5. Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for chronic rhinosinusitis (CRS)
6. Annualized rate of SCS course or surgery for CRS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 12

Locations

15 EU/EEA countries · 83 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 75 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications