Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SAR441344 IV
SAR441344 · 4 trials · 5 indications
A composite endpoint, with SRI-4 response requiring a ≥ 4-point improvement (reduction) from baseline in Hybrid Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (hSELENA-SLEDAI), no new British Isles Lupus Assessment Group (BILAG-2004) A organ domain scores, or ≥ 2 new BILAG-2004 B organ domain scores compared with baseline, no worsening from baseline in lupus disease activity, and no permanent discontinuation of study drug or use of new or increased medication for SLE other than defined per protocol.
Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.
ESSDAI is validated and established outcome measurement for therapeutic efficacy in Sjögren's syndrome, evaluating disease activity mainly on extra-glandular manifestations. This score consists of 12 organ-specific domains (constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral and central nervous system, hematological, biological), which are scored based on organ-specific items in 3 to 4 different severity grades (no, low, moderate, high; with 0=no and 3=high). These scores are summed up over all 12 domains in weighted way (severity grades are multiplied with weights ranging 1-6 depending on domain) to summarize into total score(0-123). Higher scores indicates worse outcome. Negative change from baseline indicates improvement. Baseline=Day 1 assessment value. Least squares (LS) mean is calculated using mixed models for repeated measures (MMRM). Observed values after occurrence of intercurrent events are excluded.
Number of participants with AE from baseline to day 127
Number of participants with AE from baseline to day 155
| Arm | Type | Description |
|---|---|---|
| Frexalimab | EXPERIMENTAL | Frexalimab intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo IV loading dose followed by SC, 24 weeks |
| Intravenous (IV) SAR441344 | EXPERIMENTAL | SAR441344 IV |
| IV Placebo | PLACEBO_COMPARATOR | Placebo IV |
| Subcutaneous (SC) SAR441344 | EXPERIMENTAL | SAR441344 SC |
| SC Placebo | PLACEBO_COMPARATOR | Placebo SC |
| SAR441344 | EXPERIMENTAL | SAR441344 single intravenous (IV) loading dose on Day 1 followed by a single subcutaneous (SC) dose administered once every 2 weeks from Week 2 to Week 10 (5 administrations) |
| Name | Type | Description |
|---|---|---|
| SAR441344 IV | DRUG | Pharmaceutical form: solution Route of administration: Intravenous infusion |
| SAR441344 SC | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous injection |
| Placebo IV | DRUG | Pharmaceutical form: solution Route of administration: Intravenous infusion |
| Placebo SC | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous injection |
| MRI contrast-enhancing preparations | DRUG | gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem |
| SAR441344 | DRUG | Pharmaceutical form: solution for injection Route of administration: intravenous or subcutaneous |
| Placebo | DRUG | Pharmaceutical form: solution for injection Route of administration: intravenous or subcutaneous |
| Keyhole limpet hemocyanin | BIOLOGICAL | Subcutaneous Lyophilized powder for reconstitution |
Inclusion Criteria: * Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria * Positive antinuclear antibody (ANA) (titer ≥1:80) during screening * Positivity for at least one serol...
SAR441344 is an investigational small molecule being studied for multiple sclerosis, systemic lupus erythematosus, Sjögren's syndrome, and in healthy volunteers. It is being developed by Sanofi and is currently in clinical trials, though it is not yet approved by the FDA.
SAR441344 targets CD40L, a protein involved in immune system regulation. By targeting CD40L, the drug aims to modulate immune responses that contribute to autoimmune diseases such as multiple sclerosis, systemic lupus erythematosus, and Sjögren's syndrome.
SAR441344 is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in various autoimmune conditions.
SAR441344 is in Phase 1 and Phase 2 clinical trials. Phase 1 studies have been completed in healthy volunteers, while Phase 2 trials are ongoing or completed for multiple sclerosis, systemic lupus erythematosus, and Sjögren's syndrome. The drug remains investigational and is not yet approved.
SAR441344 has been studied in several clinical trials, including NCT04572841 for Sjögren's syndrome, NCT04879628 for relapsing multiple sclerosis, NCT05039840 for systemic lupus erythematosus, and NCT05845996 in healthy volunteers. These trials assess safety, tolerability, pharmacokinetics, and efficacy.
Yes, SAR441344 is also known as frexalimab. Clinical trial titles refer to SAR441344 as frexalimab, such as in the proof-of-concept study for relapsing multiple sclerosis. Both names refer to the same investigational drug being developed by Sanofi.