Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SAR443765
Lunsekimig · 10 trials · 4 indications
Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo
Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Asthma exacerbation event defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit due to asthma and requiring the use of systemic corticosteroids or death due to asthma
Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
This score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. NP is graded based on polyp size where: 0- no polyps and 4- large polyps causing complete obstruction of the inferior nasal cavity.
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| Lunsekimig core study | EXPERIMENTAL | Subcutaneous (SC) administration of lunsekimig for up to 96 weeks, with the same inhaled controller medication as in the parent study (LABA + LAMA + ICS or LABA + LAMA) |
| Lunsekimig sub-study with ICS maintenance | EXPERIMENTAL | ICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to maintain the same inhaled regimen |
| Lunsekimig sub-study with ICS withdrawal | EXPERIMENTAL | ICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to withdraw ICS |
| Lunsekimig dose regimen A | EXPERIMENTAL | Participants will receive lunsekimig dose regimen A. |
| Lunsekimig dose regimen B | EXPERIMENTAL | Participants will receive lunsekimig dose regimen B. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive lunsekimig-matching placebo. |
| Lunsekimig | EXPERIMENTAL | Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 144 weeks |
| Lunsekimig arm A | EXPERIMENTAL | Participants will receive subcutaneous injection of lunsekimig dosing regimen A. |
| Placebo arm B | PLACEBO_COMPARATOR | Participants will receive subcutaneous injection of matching placebo. |
| Lunsekimig arm C | EXPERIMENTAL | Participants will receive subcutaneous injection of lunsekimig dosing regimen C. |
| Placebo arm D | PLACEBO_COMPARATOR | Participants will receive subcutaneous injection of matching placebo. |
| Lunsekimig arm E | EXPERIMENTAL | Participants will receive subcutaneous injection of lunsekimig dosing regimen E. |
| Placebo arm F | PLACEBO_COMPARATOR | Participants will receive subcutaneous injection of matching placebo. |
| Arm 1 | PLACEBO_COMPARATOR | Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks. |
| Arm 2 | EXPERIMENTAL | Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks. |
| Lunsekimig Dose1 interval 1 | EXPERIMENTAL | Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1 |
| Lunsekimig Dose 1 interval 2 | EXPERIMENTAL | Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2 |
| Lunsekimig Dose 2 interval 1 | EXPERIMENTAL | Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1 |
| Lunsekimig Dose 2 interval 2 | EXPERIMENTAL | Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2 |
| SAR443765 | EXPERIMENTAL | Single dose administration of SAR443765 |
| Name | Type | Description |
|---|---|---|
| Lunsekimig | DRUG | * Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection |
| Placebo | DRUG | Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection |
| Mometasone furoate nasal spray (MFNS) | DRUG | * Pharmaceutical form: Solution for administration via spray pump * Route of administration: intranasal spray |
| Short-Acting Beta Agonists (SABA) | DRUG | Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation |
| Fluticasone/Salmeterol | DRUG | Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation |
| Budesonide/Formoterol | DRUG | Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation |
| Budesonide/Albuterol | DRUG | Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation |
| SAR443765 | DRUG | solution for injection |
| Salbutamol or levosalbutamol | DRUG | metered dose inhaler |
Inclusion Criteria: * Participants who completed the treatment period of EFC18243 or EFC18244 studies, including EOI visit * Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And: * Fema...
Lunsekimig is an investigational small molecule developed by Sanofi for respiratory and immunologic conditions. It is being studied in asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps, and atopic dermatitis. It remains in clinical development and is not described as approved.
Lunsekimig is being studied for chronic obstructive pulmonary disease, including COPD characterized by an eosinophilic phenotype and inadequately controlled disease. Two Phase 3 trials, NCT07190222 and NCT07190209, each plan to enroll 942 adults aged 40 and older, and a long-term safety study, NCT07793409, plans 1,508 participants.
Sanofi develops Lunsekimig. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is running the clinical program across multiple countries, including the United States, United Kingdom, Canada, China, Germany, Japan, and others listed for the individual trials.
Lunsekimig is in Phase 2 and Phase 3 clinical development. The COPD program has advanced to Phase 3, with trials NCT07793409, NCT07190222, and NCT07190209 currently recruiting. A Phase 2 long-term extension in chronic rhinosinusitis with nasal polyps, NCT06914908, is enrolling by invitation.
Lunsekimig is being evaluated in NCT07793409, a Phase 3 long-term safety and efficacy study in adults with COPD; NCT07190222 and NCT07190209, two Phase 3 placebo-controlled COPD studies in eosinophilic phenotype patients; and NCT06914908, a Phase 2 long-term extension in chronic rhinosinusitis with nasal polyps.
The Lunsekimig clinical program has a total planned enrollment of 3,392 participants across its trials. The three COPD studies account for most of that number, with 1,508 participants in NCT07793409 and 942 each in NCT07190222 and NCT07190209. The CRSwNP extension study, NCT06914908, plans 71 participants.