An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (NCT07424144) — UK Trial Details

Condition(s) studied

Chronic Rhinosinusitis With Nasal Polyps

Investigational drug(s) / intervention(s)

Itepekimab (SAR440340)Placebo

Itepekimab (SAR440340): Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

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

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

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.

Primary outcome measure(s)

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 — 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

Trial sites (23)

Facility	City	Region
Velocity Clinical Research - San Diego- Site Number : 8402041	La Mesa	California
Allergy, Asthma and Clinical Research- Site Number : 8402002	Oklahoma City	Oklahoma
Investigational Site Number : 0362001	Spearwood	Western Australia
Investigational Site Number : 1241001	Québec	Quebec
Investigational Site Number : 1242003	Québec	Quebec
Investigational Site Number : 1242012	Québec	Quebec
Investigational Site Number : 1522001	Concepción	Biobio
Investigational Site Number : 1521003	Talca	Maule Region
Investigational Site Number : 1522003	Santiago	Reg Metropolitana de Santiago
Investigational Site Number : 1521002	Santiago	Reg Metropolitana de Santiago
Investigational Site Number : 1521001	Santiago	Reg Metropolitana de Santiago
Investigational Site Number : 1562012	Baotou	China
Investigational Site Number : 1562001	Beijing	China
Investigational Site Number : 1562004	Chengdu	China
Investigational Site Number : 1562008	Jingzhou	China
Investigational Site Number : 1562006	Shenyang	China
Investigational Site Number : 1562010	Taiyuan	China
Investigational Site Number : 2032001	Prague	Czechia
Investigational Site Number : 3481002	Budapest	Hungary
Investigational Site Number : 4101003	Seoul	Seoul-teukbyeolsi
Investigational Site Number : 4101001	Seoul	Seoul-teukbyeolsi
Investigational Site Number : 8262002	Wigan	Lancashire
Investigational Site Number : 8261004	Bradford	United Kingdom

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