Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lunsekimig · 9 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.
| 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 |
| 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 |
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 being developed for chronic rhinosinusitis with nasal polyps, chronic obstructive pulmonary disease, dermatitis atopic, and asthma. It is currently in Phase 2 clinical development for these respiratory and inflammatory conditions.
Lunsekimig is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker SNY.
Lunsekimig is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or recently completed to evaluate its safety and efficacy.
Lunsekimig has been studied in several Phase 2 trials. NCT06102005 evaluated dose ranging in moderate-to-severe asthma, NCT06454240 was a proof-of-concept study in chronic rhinosinusitis with nasal polyps, NCT06676319 is studying high-risk asthma, and NCT06914908 is a long-term safety extension in nasal polyps.
Yes, Lunsekimig is also known as SAR443765. One of its clinical trials, NCT06676319, explicitly refers to Lunsekimig (SAR443765) in the study title, confirming that these names refer to the same drug.