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Also known as Itepekimab (SAR440340)
Itepekimab · 7 trials · 4 indications
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).
All AEs (serious or nonserious) will be collected from the signing of the ICF until end of study (EOS) visit
The Nasal Congestion Score (NCS) is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.
All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit
Change from baseline in sinus inflammation as assessed by Computerized Tomography (CT) scan of the sinuses in the itepekimab-- compared to placebo-- treated study participants on the background of intranasal corticosteroid (INCS).
Annualized rate of moderate or severe PEs over the placebo-controlled treatment period
| Arm | Type | Description |
|---|---|---|
| Itepekimab high dose | EXPERIMENTAL | Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks |
| Itepekimab low dose | EXPERIMENTAL | SC administration of Itepekimab low dose for 52 weeks |
| Placebo | PLACEBO_COMPARATOR | SC administration of matching placebo for 52 weeks |
| Itepekimab Q2W | EXPERIMENTAL | Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks |
| Itepekimab Q4W | EXPERIMENTAL | SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP |
| Name | Type | Description |
|---|---|---|
| Itepekimab (SAR440340) | DRUG | Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous |
| Placebo | DRUG | Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous |
| Mometasone furoate nasal spray (MFNS) | DRUG | Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray |
Inclusion Criteria: * Participants must be 18 years of age or older. * Participants with a history of CRSwNP for at least 1 year. * Participants must have at least one of the following features: * Prior sinonasal surgery for NP. * Worsening symptoms of CRS requiring treatment with SCS within t...
Itepekimab is an investigational drug being studied for chronic rhinosinusitis with nasal polyps, chronic obstructive pulmonary disease, bronchiectasis, and chronic rhinosinusitis without nasal polyps. It is currently in Phase 2 development for these respiratory conditions.
Itepekimab targets IL-33, a cytokine involved in inflammatory responses. It is an inhibitor of IL-33, designed to block its activity. This mechanism is being investigated for its potential to treat chronic rhinosinusitis with nasal polyps and other respiratory conditions.
Itepekimab is being developed by Sanofi, a global biopharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY.
Itepekimab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied for chronic rhinosinusitis with nasal polyps and other respiratory conditions.
Itepekimab is being studied in several clinical trials, including NCT06834347, NCT06834360, NCT07424144, and NCT07484230. These trials are investigating its efficacy and safety in chronic rhinosinusitis with nasal polyps, with some trials enrolling participants in multiple countries.
Yes, Itepekimab is also known as SAR440340. Both names refer to the same investigational drug being developed by Sanofi for respiratory conditions.