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MAS825 · 5 trials · 6 indications
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.
To assess the safety and tolerability of single i.v./s.c. doses of MAS825
| Arm | Type | Description |
|---|---|---|
| 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. |
| Placebo | PLACEBO_COMPARATOR | matching placebo |
| 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 |
| MAS825 dose A | EXPERIMENTAL | single i.v. dose |
| MAS825 dose B | EXPERIMENTAL | single s.c. dose |
| Placebo dose A | PLACEBO_COMPARATOR | single i.v. dose |
| Placebo dose B | PLACEBO_COMPARATOR | single s.c. dose |
| Name | Type | Description |
|---|---|---|
| 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 |
| Placebo | BIOLOGICAL | matching placebo |
| 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: * Age ≥ 1 with a diagnosis of Still's Disease * Active diseases defined as: * CRP or ferritin levels greater than ULN, and any of: * Fever ≥ 38°C attributed to Still's Disease activity and documented for a number of days prior to Day 1 or * Rash attributed to Still's Diseas...
MAS825 is an investigational small molecule being developed by Novartis for several inflammatory and infectious conditions. In clinical trials, it is being studied for COVID-19 pneumonia, impaired respiratory function, monogenic IL-18 driven autoinflammatory diseases including NLRC4-GOF, AIFEC, XIAP deficiency, and CDC42 mutations, as well as coronary heart disease with clonal hematopoiesis of indeterminate potential.
MAS825 targets the IL-18 pathway, as it is being studied in diseases driven by IL-18, such as NLRC4-GOF, XIAP deficiency, and CDC42 mutations. The drug is designed to modulate this inflammatory signaling pathway to reduce disease activity.
MAS825 is developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker NVS. Novartis is conducting multiple clinical trials to evaluate the drug's safety and efficacy across different patient populations.
MAS825 is in Phase 2 clinical development. It has completed Phase 1 studies in healthy volunteers and is currently being evaluated in Phase 2 trials for COVID-19 pneumonia, autoinflammatory diseases, and coronary heart disease. It remains investigational and has not been approved by regulatory authorities.
MAS825 has been studied in several clinical trials. NCT04382651 evaluated its efficacy and safety in COVID-19 patients with pneumonia and impaired respiratory function. NCT04641442 is an active Phase 2 study in patients with monogenic IL-18 driven autoinflammatory diseases. NCT04665154 was a first-in-human study in healthy volunteers, and NCT06097663 investigated its effects in coronary heart disease with CHIP.
MAS825 is not the same as DFV890. They are distinct investigational drugs being studied by Novartis. In clinical trial NCT06097663, both MAS825 and DFV890 are being evaluated separately for their ability to reduce inflammatory markers in adult participants with coronary heart disease and clonal hematopoiesis of indeterminate potential.