An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Itepekimab (SAR440340), Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Rhinosinusitis With Nasal Polyps. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, Chile, China +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Itepekimab (SAR440340)
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous - Drug Placebo
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Primary outcome 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 discontinuation [Time frame: Baseline to EOS (Week 72)]
Secondary outcome measures (6)
- Change from baseline of the parent studies (EFC18418, EFC18419) in endoscopic NPS [Time frame: Baseline to Week 52]
- Change from baseline of the parent studies (EFC18418, EFC18419) in NCS [Time frame: Baseline to EOS (Week 72)]
- Functional itepekimab concentration in serum [Time frame: Baseline to EOS (Week 72)]
- Incidence of treatment-emergent anti-drug antibody (ADA) responses [Time frame: Baseline to EOS (Week 72)]
- Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for chronic rhinosinusitis (CRS) [Time frame: Baseline up to Week 52]
- Annualized rate of SCS course or surgery for CRS [Time frame: Baseline up to Week 52]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 6 centers
- Investigational Site Number : 1562012 — Baotou
- Investigational Site Number : 1562001 — Beijing
- Investigational Site Number : 1562004 — Chengdu
- Investigational Site Number : 1562008 — Jingzhou
- Investigational Site Number : 1562006 — Shenyang
- Investigational Site Number : 1562010 — Taiyuan
Chile · 5 centers
- Investigational Site Number : 1522001 — Concepción
- Investigational Site Number : 1521003 — Talca
- Investigational Site Number : 1522003 — Santiago
- Investigational Site Number : 1521002 — Santiago
- Investigational Site Number : 1521001 — Santiago
Canada · 3 centers
- Investigational Site Number : 1241001 — Québec
- Investigational Site Number : 1242003 — Québec
- Investigational Site Number : 1242012 — Québec
United States · 2 centers
- Velocity Clinical Research - San Diego- Site Number : 8402041 — La Mesa
- Allergy, Asthma and Clinical Research- Site Number : 8402002 — Oklahoma City
South Korea · 2 centers
- Investigational Site Number : 4101003 — Seoul
- Investigational Site Number : 4101001 — Seoul
United Kingdom · 2 centers
- Investigational Site Number : 8262002 — Wigan
- Investigational Site Number : 8261004 — Bradford
Australia · 1 center
- Investigational Site Number : 0362001 — Spearwood
Czechia · 1 center
- Investigational Site Number : 2032001 — Prague
Hungary · 1 center
- Investigational Site Number : 3481002 — Budapest
Identifiers
NCT: NCT07424144 · LTS18420 · 2025-522983-33 · U1111-1320-4430