Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR445399 · 1 trial · 1 indication
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
| Arm | Type | Description |
|---|---|---|
| SAR445399 dose regimen A | EXPERIMENTAL | Participants will receive SAR445399 dose regimen A. |
| SAR445399 dose regimen B | EXPERIMENTAL | Participants will receive SAR445399 dose regimen B. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive SAR445399-matching placebo. |
| Name | Type | Description |
|---|---|---|
| SAR445399 | DRUG | Pharmaceutical form: Solution for injection -Route of administration: Injection |
| Placebo | DRUG | Pharmaceutical form: Solution for injection -Route of administration: Injection |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline * Participants must have HS lesions prese...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib |
| Incyte Corporation | INCY | 6 | PHASE3 | Povorcitinib |
| Novartis AG Sponsored ADR | NVS | 11 | PHASE3 | Remibrutinib Dose A, Remibrutinib Dose B |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Brivekimig |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab Dose A, Tibulizumab Dose B |
| Sonoma Pharmaceuticals, Inc. | SNOA | 2 | PHASE1 | SBT777101 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
SAR445399 is an investigational small molecule being studied for the treatment of moderate to severe hidradenitis suppurativa in adults. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SAR445399 is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
SAR445399 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The ongoing Phase 2 trial is recruiting participants to assess its efficacy and safety in hidradenitis suppurativa.
SAR445399 is being evaluated in a Phase 2 clinical trial registered as NCT07225569. This randomized, double-blind, placebo-controlled study is investigating the efficacy and safety of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa, with an enrollment target of 144 participants.
SAR445399 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for hidradenitis suppurativa. The ongoing study is designed to gather data on its efficacy and safety, which would be necessary before any regulatory approval could be considered.