Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Itepekimab SAR440340 · 3 trials · 1 indication
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period
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 | 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 |
| Placebo | PLACEBO_COMPARATOR | SC administration of matching placebo 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 report ...
Itepekimab SAR440340 is an investigational drug being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its efficacy, safety, and tolerability in patients with COPD.
Itepekimab SAR440340 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to assess the drug's potential as a treatment for Chronic Obstructive Pulmonary Disease.
Itepekimab SAR440340 is in Phase 3 clinical development for Chronic Obstructive Pulmonary Disease. The drug is investigational and has not yet received regulatory approval. Three clinical trials have been completed, including two Phase 3 studies and one Phase 2 mechanistic study, with a total enrollment of 2,415 participants.
Itepekimab SAR440340 has completed three clinical trials for Chronic Obstructive Pulmonary Disease. The Phase 3 trials are NCT04701983 with 1,127 participants and NCT04751487 with 1,239 participants. A Phase 2 mechanistic study, NCT05326412, enrolled 49 participants. All trials were randomized, double-blind, and placebo-controlled.
Yes, Itepekimab SAR440340 is also known as SAR440340 and REGN3500. These names refer to the same investigational drug being developed by Sanofi for Chronic Obstructive Pulmonary Disease. The clinical trials for this drug use these alternative names interchangeably in their titles and documentation.
Itepekimab SAR440340 is a small molecule being studied for its effects on airway inflammation in patients with Chronic Obstructive Pulmonary Disease. The Phase 2 mechanistic study specifically evaluated how the drug influences inflammation in the airways, providing insight into its potential therapeutic action in COPD.