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Remibrutinib Dose A · 2 trials · 1 indication
HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Remibrutinib Dose A (Treatment Period 1 and 2) | EXPERIMENTAL | Participants randomized to receive remibrutinib Dose A during Treatment Period 1 and 2 |
| Remibrutinib Dose B (Treatment Period 1 and 2) | EXPERIMENTAL | Participants randomized to receive remibrutinib Dose B during Treatment Period 1 and 2 |
| Placebo (Treatment Period 1) + remibrutinib Dose B (Treatment Period 2) | PLACEBO_COMPARATOR | Participants randomized to receive placebo during Treatment Period 1 followed by remibrutinib dose B during Treatment Period 2 |
| Name | Type | Description |
|---|---|---|
| Remibrutinib Dose A | DRUG | Remibrutinib Dose A (oral) |
| Remibrutinib Dose B | DRUG | Remibrutinib Dose B (oral) |
| Placebo 1 | DRUG | Placebo matching to remibrutinib Dose A (oral) |
| Placebo 2 | DRUG | Placebo matching to remibrutinib Dose B (oral) |
Key Inclusion Criteria: 1. Male and female participants ≥ 12 years of age at the time of signing of the informed consent. 2. Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit. 3. Participants with moderate to severe HS defined as: ...
| 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 |
Remibrutinib Dose A is an investigational small molecule being studied for the treatment of moderate to severe hidradenitis suppurativa in adult and adolescent patients aged 12 years and older. It is a kinase inhibitor, as indicated by its -tinib suffix, and is currently in Phase 3 clinical development.
Remibrutinib Dose A is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting the Phase 3 clinical trials for this investigational drug in hidradenitis suppurativa.
Remibrutinib Dose A is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials are currently active but not recruiting participants, with a combined planned enrollment of 1,153 patients.
Remibrutinib Dose A is being evaluated in two Phase 3 trials: NCT06799000, known as RECHARGE 1, with 588 participants, and NCT06840392, with 565 participants. Both are randomized, double-blind, placebo-controlled studies enrolling adults and adolescents with moderate to severe hidradenitis suppurativa.
Remibrutinib Dose A is a kinase inhibitor, a class of drugs that block enzymes involved in cellular signaling. By inhibiting kinase activity, it is intended to modulate inflammatory pathways relevant to hidradenitis suppurativa, though the specific molecular target is not disclosed in the available trial information.
Remibrutinib Dose A is a specific dose formulation of the investigational drug remibrutinib, developed by Novartis. The Phase 3 trials for hidradenitis suppurativa are testing this particular dose, and the drug is referred to as Remibrutinib Dose A in the study context.