Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MAS825
Arumakimig · 5 trials · 6 indications
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.
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Serum levels of IL-6 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-6 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor. The Emax model selected for IL-6 analysis was a model with 2 covariates (IL-6 baseline and bodyweight) and 1 random effect.
Serum levels of IL-18 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-18 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor. The Emax model selected for IL-18 was a model with one covariate (IL-18 baseline) and 1 random effect.
Serum level of IL-6 at Week 3 for MAS825. The circulating serum levels of the cytokine IL-6 was measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor. Data was analyzed with a a traditional linear regression model including treatment as a fixed categorical effect, a random intercept effect for participant, and the baseline value of the biomarker and baseline body weight as covariates.
To determine the efficacy of MAS825 in prevention of flares in patients with monogenic IL-18 driven autoinflammatory diseases, including NLRC4-GOF, XIAP deficiency or CDC42 mutations
The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. In practice, it is rare for any participant to accumulate more than 55 points. APACHE II score was measured on Day 15 or on the day of discharge (whichever was earlier). Participants who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the participants at any time during the trial (worst case imputation for deaths). Missing data values of the parameters required for the derivation of the APACHE II score were replaced by the last available assessment.
| 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. |
| MAS825 | EXPERIMENTAL | Experimental drug |
| Treatment Sequence 1 | EXPERIMENTAL | On Day 1, participants received the single s.c. dose of MAS825 and DFV890 oral placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 84. |
| Treatment Sequence 2 | EXPERIMENTAL | On Day 1, participants received the single s.c. dose of MAS825 placebo and DFV890 oral placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when participants started receiving DFV890 10mg QD. The dose of DFV890 was uptitrated to 25mg on Day 43 and to 100mg on Day 64. |
| Treatment Sequence 3 | EXPERIMENTAL | On Day 1, participants received the single s.c. dose of MAS825 placebo and DFV890 oral placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when participants started receiving DFV890 25mg QD. The dose of DFV890 was uptitrated to 50mg on Day 43 and to 100mg on Day 64. |
| Treatment Sequence 4 | EXPERIMENTAL | On Day 1, participants received the single s.c. dose of MAS825 placebo and DFV890 10 mg QD. Participants continued receiving DFV890 10 mg QD until Day 22 when the dose of DFV890 was uptitrated to 25mg QD. On Day 43 the dose of DFV890 was uptitrated to 50mg and on Day 64 to 100mg. |
| Treatment Sequence 5 | PLACEBO_COMPARATOR | On Day 1, participants received the single s.c. dose of MAS825 placebo and DFV890 oral placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 84. |
| MAS825 + SoC | EXPERIMENTAL | Single dose of MAS825 10 mg/kg by intravenous infusion in addition to SoC |
| Placebo + SoC | PLACEBO_COMPARATOR | Single dose of matching Placebo by intravenous infusion in addition to SoC |
| 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. |
| MAS825 | DRUG | Experimental drug |
| MAS825 Placebo | DRUG | MAS825 placebo single dose |
| DFV890 | DRUG | Oral tablet of DFV890 active once daily |
| DFV890 placebo | DRUG | Oral tablet of DFV890 placebo once daily |
| Standard of Care (SoC) | DRUG | SoC included a variety of supportive therapies that ranged from the administration of supplementary oxygen to full intensive care support, alongside the use of antiviral treatment, convalescent plasma, corticosteroids, antibiotics or other agents. |
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 medicine being studied for several inflammatory and immune conditions, including VEXAS syndrome, Still's disease, monogenic IL-18 driven autoinflammatory diseases such as NLRC4-GOF, XIAP deficiency and CDC42 mutations, and coronary heart disease with clonal hematopoiesis of indeterminate potential. It is also being evaluated in COVID-19 pneumonia with impaired respiratory function.
Arumakimig is developed by Novartis AG, which trades under the ticker NVS. Novartis is running the clinical development program for the drug across its current Phase 2 studies.
Arumakimig is in Phase 2 clinical development. It has not been approved by the FDA, and it remains an investigational drug being evaluated in clinical trials.
Arumakimig is being studied in several Phase 2 trials, including NCT07748624 in VEXAS syndrome, NCT07203001 in Still's disease, NCT06097663 in coronary heart disease with CHIP, and NCT04641442 in monogenic IL-18 driven autoinflammatory diseases. The VEXAS and Still's disease trials are currently recruiting.
Yes, Arumakimig is also known as MAS825. Both names refer to the same investigational drug developed by Novartis AG.