Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Arumakimig · 1 trial · 1 indication
Response is defined as meeting both criteria: A) Clinical domain: In participants with clinical disease activity in any domain at baseline, complete resolution of clinical manifestations related to active disease in at least one affected domain. In participants with no clinical disease activity in any domain at baseline, continued absence of clinical manifestations in all domains at Week 52. AND B) Protocol-defined glucocorticoid reduction through 52 weeks.
| Arm | Type | Description |
|---|---|---|
| Arumakimig | EXPERIMENTAL | Arumakimig from Day 1 to Week 52 during the double-blind period. Eligible participants may then continue into an open-label extension and receive arumakimig through Week 156. |
| Placebo | PLACEBO_COMPARATOR | Placebo from Day 1 to Week 52 during the double-blind period. Eligible participants may then continue into an open-label extension and receive arumakimig through Week 156. |
| Name | Type | Description |
|---|---|---|
| Arumakimig | DRUG | Arumakimig Injection |
| Placebo | DRUG | Placebo Injection |
| Oral glucocorticoids | DRUG | Background therapy with glucocorticoids. After the first 2 weeks of the study, participants may begin with glucocorticoid tapering depending on the disease status and the Investigator's judgement. |
Inclusion Criteria: * Male and female participants aged ≥18 years at screening. * Somatic mutation in UBA1 gene known to be associated with VEXAS. * Participants must have at least two manifestations of VEXAS at screening or in the past 6 months. * Participants must be able to start treatment for P...
Arumakimig is an investigational small molecule being developed for the treatment of VEXAS Syndrome, a rare autoinflammatory disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Arumakimig is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS.
Arumakimig is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved for commercial use. The ongoing Phase 2 trial is designed to evaluate its efficacy and safety in patients with VEXAS Syndrome.
Arumakimig is being studied in a Phase 2 clinical trial registered as NCT07748624. This is a 52-week, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Arumakimig in participants with VEXAS Syndrome, followed by an open-label extension period. The trial plans to enroll 120 participants.
Yes, Arumakimig is also known as MAS825. The clinical trial NCT07748624 refers to the drug as Arumakimig (MAS825), indicating that both names are used for the same investigational compound.