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Also known as Itepekimab (SAR440340)
Itepekimab · 6 trials · 4 indications
All AEs (serious or nonserious) will be collected from the signing of the ICF until end of study (EOS) visit
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).
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 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 ...
Itepekimab is an investigational monoclonal antibody developed by Sanofi for respiratory and inflammatory conditions. It is being studied in chronic rhinosinusitis with and without nasal polyps, chronic obstructive pulmonary disease, and bronchiectasis. It is not yet approved and remains in clinical development.
Itepekimab is being evaluated for chronic rhinosinusitis with nasal polyps, chronic rhinosinusitis without nasal polyps, chronic obstructive pulmonary disease, and bronchiectasis. The most advanced program is in inadequately controlled chronic rhinosinusitis with nasal polyps, where Phase 3 studies are ongoing.
Itepekimab targets IL33, an alarmin cytokine involved in type 2 inflammation. It is an inhibitor monoclonal antibody that binds IL33 and blocks its signaling. This mechanism is being explored across inflammatory airway diseases including chronic rhinosinusitis and COPD.
Itepekimab is developed by Sanofi, which trades under the ticker SNY. Sanofi is running the clinical program, including the Phase 3 studies in chronic rhinosinusitis with nasal polyps and the completed Phase 2 proof-of-concept study in chronic rhinosinusitis without nasal polyps.
Itepekimab is in Phase 3 development for chronic rhinosinusitis with nasal polyps, with three active Phase 3 studies. A Phase 2 proof-of-concept study in chronic rhinosinusitis without nasal polyps has been completed. It is investigational and has not been approved by the FDA.
Itepekimab is being studied in NCT06834360 and NCT06834347, two Phase 3 trials in inadequately controlled chronic rhinosinusitis with nasal polyps, and NCT07424144, a Phase 3 long-term extension study in the same condition. The completed Phase 2 study in chronic rhinosinusitis without nasal polyps is NCT06691113.
Yes, itepekimab is also known as SAR440340. Both names refer to the same anti-IL-33 monoclonal antibody developed by Sanofi. Searches for either name lead to the same clinical development program in chronic rhinosinusitis, COPD, and bronchiectasis.