Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06840392 | A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa | PHASE3 | ACTIVE NOT_RECRUITING | 565 | — | — | Mar 20, 2025 | Oct 21, 2027 | Jun 5, 2026 | 131 | United States, Argentina +17 |
| NCT06799000 | A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1) | PHASE3 | ACTIVE NOT_RECRUITING | 588 | — | — | Jan 31, 2025 | Oct 4, 2027 | May 22, 2026 | 138 | United States, Argentina +18 |
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 | articipants 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 | Lutikizumab, Upadacitinib |
| Incyte Corporation | INCY | 6 | PHASE3 | Povorcitinib, povorcitinib, Ruxolitinib, Vehicle |
| Novartis AG Sponsored ADR | NVS | 12 | PHASE3 | secukinumab, Remibrutinib Dose A, Remibrutinib Dose B, CFZ533, LYS006 |
| MoonLake Immunotherapeutics Class A | MLTX | 4 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Brivekimig, SAR445399 |
| Insmed Incorporated | INSM | 1 | PHASE2 | Brensocatib |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Eltrekibart |
| 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 |