Chronic Rhinosinusitis With Nasal Polyps
Conditions
Brief 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.
Interventions
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
DRUGPlacebo
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of the parent studies (EFC18418, EFC18419) in endoscopic NPS | Baseline to Week 52 | The Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps). |
| Change from baseline of the parent studies (EFC18418, EFC18419) in NCS | Baseline to EOS (Week 72) | The Nasal Congestion Score (NCS) is scored using a 0 to 3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. |
| Functional itepekimab concentration in serum | Baseline to EOS (Week 72) | — |
| Incidence of treatment-emergent anti-drug antibody (ADA) responses | Baseline to EOS (Week 72) | — |
| Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for chronic rhinosinusitis (CRS) | Baseline up to Week 52 | — |
| Annualized rate of SCS course or surgery for CRS | Baseline up to Week 52 | — |
Countries
United Kingdom
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Outcome results
None listed