Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Itepekimab (SAR440340), SAR440340, REGN3500
Itepekimab · 8 trials · 5 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).
PEs were recorded by Investigator. Moderate PEs were defined as acute worsening of respiratory symptoms (\>=3 symptoms for \>=48 hours) requiring antibiotic treatment. Severe PEs were moderate PEs resulting in intravenous antibiotic treatment, hospitalization, observation \>24 hours in emergency department/urgent care, or death. Events separated by \<14 days were considered as single events. All PE events were adjudicated by an independent committee. For both moderate and severe events to be counted as 2 separate events, they were separated by at least 14 days between any course of antibiotics and/or systemic corticosteroids or 14 days between discharge and new admission in case of hospitalization (severe events only). Annualized rate: number of events divided by total observation duration and was estimated based on negative binomial regression.
Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
An LOAC event during the 12-week treatment period was a deterioration of asthma defined as any of the following: a) 30 percent (%) or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; b) greater than or equal to (\>=) 6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; c) increase in inhaled corticosteroid (ICS) \>=4 times the last prescribed ICS dose (or \>=50% of the prescribed ICS dose at Baseline if background therapy withdrawal completed); d) required use of systemic (oral and/or parenteral) steroid treatment; e) required hospitalization or emergency room visit.
| 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 |
| SAR440340 | EXPERIMENTAL | Participants received SAR440340 300 milligrams (mg) administered as 2 SC injections Q2W. Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of IMP i.e., at Week 52). |
| Dupilumab | ACTIVE_COMPARATOR | Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks. |
| SAR440340 + Dupilumab | EXPERIMENTAL | Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks. |
| 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 |
| SAR440340 | DRUG | Pharmaceutical form: Solution for injection; Route of administration: SC |
| Any Inhaled Corticosteroids as prescribed by treating physician as standard of care | DRUG | Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled |
| Any Long Acting Beta Agonist as prescribed by treating physician as standard of care | DRUG | Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled |
| Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care | DRUG | Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled |
| Any short-acting β agonist as prescribed by treating physician as standard of care | DRUG | Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled |
| Dupilumab | DRUG | Pharmaceutical form: Solution for Injection, Route of administration: SC |
| Fluticasone or Fluticasone/salmeterol combination | DRUG | Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled |
| Placebo for SAR440340 | DRUG | Pharmaceutical form: Solution for Injection, Route of administration: SC |
| Placebo for dupilumab | DRUG | Pharmaceutical form: Solution for Injection, Route of administration: SC |
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 targets IL33, an alarmin cytokine involved in type 2 inflammation. It is an IL33 inhibitor, meaning it is designed to block IL33 signaling. This mechanism is being explored across inflammatory airway diseases including chronic rhinosinusitis with nasal polyps and COPD.
Itepekimab is developed by Sanofi, which trades under the ticker SNY. Sanofi is running the clinical development program, including Phase 3 studies in chronic rhinosinusitis with nasal polyps and a 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 listed. A Phase 2 proof-of-concept study in chronic rhinosinusitis without nasal polyps has been completed. The drug 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. NCT06691113, a completed Phase 2 proof-of-concept study, evaluated chronic rhinosinusitis without nasal polyps.
Yes, itepekimab is also known as SAR440340. SAR440340 is Sanofi's internal compound designation for the same anti-IL-33 monoclonal antibody. Both names refer to the identical investigational drug being studied in chronic rhinosinusitis with nasal polyps, chronic rhinosinusitis without nasal polyps, COPD, and bronchiectasis.