Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as REGN3500
Itepekimab SAR440340 · 3 trials · 1 indication
Exacerbations were recorded by Investigator. Moderate exacerbations were defined as acute worsening of respiratory symptoms that required either systemic corticosteroids (such as intramuscular \[IM\], intravenous \[IV\], or oral) and/or antibiotics. Severe exacerbations were defined as AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. For both moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of systemic steroids/antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events only). Annualized rate was total number of moderate or severe exacerbation events divided by total observation duration and was estimated based on negative binomial regression. Events were adjudicated by third party.
Exacerbations were recorded by Investigator. Moderate exacerbations were defined as acute worsening of respiratory symptoms that required either systemic corticosteroids (such as intramuscular \[IM\], intravenous \[IV\], or oral) and/or antibiotics. Severe exacerbations were defined as AECOPD that required hospitalization, observation for \>24 hours in an emergency department/urgent care facility, or resulted in death. For both moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of systemic steroids/antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events only). Annualized rate was the total number of moderate or severe exacerbation events divided by the total observation duration and was estimated based on negative binomial regression. Events were adjudicated by third party.
The NES provides an indication of the difference in gene expression levels for a particular individual before and after treatment for a defined set of genes (or signature). The gene signatures are derived from the genes differentially expressed in endobronchial biopsies, bronchial brushings, and nasal brushings of former smokers. The NES in current smokers, at baseline and at Week 12, are calculated based on the gene signatures of former smokers. Change in NES from baseline indicates that the gene signature is differentially regulated in response to itepekimab, with up- and down-regulated genes changing in their expected directions. No predetermined directionality has been established for this score; therefore, a higher or lower NES does not indicate a better or worse outcome. Baseline was defined as the last available value before first dose of study treatment.
The NES provides an indication of the difference in gene expression levels for a particular individual before and after treatment for a defined set of genes (or signature). The gene signatures are derived from the genes differentially expressed in endobronchial biopsies, bronchial brushings, and nasal brushings of former smokers. The NES in current smokers, at baseline and at Week 12, are calculated based on the gene signatures of former smokers. Change in NES from baseline indicates that the gene signature is differentially regulated in response to itepekimab, with up- and down-regulated genes changing in their expected directions. No predetermined directionality has been established for this score; therefore, a higher or lower NES does not indicate a better or worse outcome. Baseline was defined as the last available value before first dose of study treatment.
The NES provides an indication of the difference in gene expression levels for a particular individual before and after treatment for a defined set of genes (or signature). The gene signatures are derived from the genes differentially expressed in endobronchial biopsies, bronchial brushings, and nasal brushings of former smokers. The NES in current smokers, at baseline and at Week 12, are calculated based on the gene signatures of former smokers. Change in NES from baseline indicates that the gene signature is differentially regulated in response to itepekimab, with up- and down-regulated genes changing in their expected directions. No predetermined directionality has been established for this score; therefore, a higher or lower NES does not indicate a better or worse outcome. Baseline was defined as the last available value before first dose of study treatment.
| Arm | Type | Description |
|---|---|---|
| Itepekimab Q2W in former smokers | EXPERIMENTAL | Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks |
| Itepekimab Q4W in former smokers | 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 |
| Placebo in former smokers | PLACEBO_COMPARATOR | SC administration of matching placebo Q2W for up to 52 weeks |
| Itepekimab Q2W in current smokers | EXPERIMENTAL | SC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks |
| Placebo in current smokers | PLACEBO_COMPARATOR | SC administration of matching placebo Q2W for 52 weeks |
| Itepekimab Q2W | EXPERIMENTAL | Participants received itepekimab 300 mg as an SC injection every 2 weeks (Q2W) for up to 52 weeks. |
| Itepekimab Q4W | EXPERIMENTAL | Participants received Itepekimab 300 mg as an SC injection every 4 weeks (Q4W) with alternating placebo matching Itepekimab administration at the 2-week interval between active study drug for up to 52 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matching Itepekimab as subcutaneous (SC) injection every 2 weeks (Q2W) for up to 52 weeks. |
| Itepekimab | EXPERIMENTAL | This arm includes participants from 2 populations: Part A-former smokers and Part B-current smokers. Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Itepekimab SAR440340 | DRUG | Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous |
| Placebo | DRUG | Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous |
Inclusion criteria : * Participant must be 40 to 85 years of age inclusive. * Physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] definition). * Smoking history of ≥10 pack-years: * For former smokers: participants who reporte...
Itepekimab is an investigational monoclonal antibody being developed for the treatment of chronic obstructive pulmonary disease (COPD). It is designed to reduce airway inflammation in adults with the condition. It has been studied in Phase 3 clinical trials in patients aged 40 years and older with COPD.
Itepekimab targets interleukin-33 (IL-33), a cytokine involved in airway inflammation. It acts as an inhibitor of IL-33 signaling. By binding to IL-33, itepekimab is intended to dampen the inflammatory cascade associated with chronic obstructive pulmonary disease.
Itepekimab is being developed by Sanofi, which trades under the ticker SNY. The drug was studied under the code SAR440340, reflecting Sanofi's internal naming convention. Development has focused on chronic obstructive pulmonary disease as the lead indication.
Itepekimab is in Phase 3 clinical development for chronic obstructive pulmonary disease. It is an investigational agent and has not been approved by the FDA. Three trials have been completed, including two Phase 3 studies and one Phase 2 mechanistic study, with no active trials currently listed.
Itepekimab has been evaluated in three completed trials. The Phase 3 studies are NCT04751487, which enrolled 1,234 patients, and NCT04701983, which enrolled 1,127 patients. A Phase 2 mechanistic study, NCT05326412, enrolled 49 patients and examined the effect of itepekimab on airway inflammation in COPD.
Yes. Itepekimab is also known by the development codes SAR440340 and REGN3500. SAR440340 is Sanofi's designation, while REGN3500 reflects the Regeneron code used in the trial titles. All three names refer to the same anti-IL-33 monoclonal antibody studied in chronic obstructive pulmonary disease.