Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mavrilimumab · 4 trials · 7 indications
Number of subjects alive and off of oxygen
Number of subjects alive and off of oxygen
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.
Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.
Time to flare by Week 26 was defined as time from randomization to the date of first flare occurring within the 26-week period, as assessed by independent adjudication. Kaplan-Meier method used to estimate the survival functions for each treatment arm. Flare/relapse was defined as a C-reactive protein (CRP) of 1 mg/dL or greater and/or erythrocyte sedimentation rate (ESR) of 30 mm/h or greater AND at least one of the following signs or symptoms attributed to GCA: Cranial symptoms (new-onset localized headache; scalp or temporal artery tenderness; ischemic-related vision loss; unexplained mouth or jaw pain upon mastication; transient ischemic attack or stroke related to GCA); Extracranial symptoms (claudication of the extremities; symptoms of polymyalgia rheumatica); New or worsening angiographic abnormalities detected via MRI, CT/CTA, or PET-CT of the aorta or other great vessels or via ultrasound of the temporal arteries.
| Arm | Type | Description |
|---|---|---|
| Intervention | ACTIVE_COMPARATOR | Treatment infusion |
| Control | PLACEBO_COMPARATOR | Placebo infusion |
| Mavrilimumab | EXPERIMENTAL | Mavrilimumab Treatment infusion |
| Placebo | PLACEBO_COMPARATOR | Placebo infusion |
| 10 mg/kg (Cohort 1) | ACTIVE_COMPARATOR | Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion |
| 6 mg/kg (Cohort 1) | ACTIVE_COMPARATOR | Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion |
| Placebo (Cohort 1) | PLACEBO_COMPARATOR | Non-mechanically ventilated participants administered placebo as a single IV infusion |
| 10 mg/kg (Cohort 2) | ACTIVE_COMPARATOR | Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion |
| 6 mg/kg (Cohort 2) | ACTIVE_COMPARATOR | Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion |
| Placebo (Cohort 2) | PLACEBO_COMPARATOR | Mechanically ventilated participants administered placebo as a single IV infusion |
| Name | Type | Description |
|---|---|---|
| Mavrilimumab | DRUG | Treatment infusion |
| Placebos | DRUG | Placebo infusion |
| Placebo | DRUG | Placebo infusion |
| prednisone | DRUG | Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP) |
Inclusion Criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Documented COVID19 pneumonia defined as positive SARS-CoV2 test AND abnormalities/ infiltrates on chest x-ray or computed tomography AND active fever or documented fever within 24-48 hours or ongo...
Mavrilimumab is an investigational drug being studied for the treatment of Giant Cell Arteritis and COVID-19, including COVID-19 pneumonia with hyper-inflammation. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Mavrilimumab is being developed by Kiniksa Pharmaceuticals International, plc, which trades under the ticker KNSA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Giant Cell Arteritis and COVID-19.
Mavrilimumab is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. Clinical trials are ongoing to assess its safety and efficacy for the treatment of Giant Cell Arteritis and COVID-19.
Mavrilimumab has been studied in several Phase 2 clinical trials, including NCT03827018 for Giant Cell Arteritis, NCT04447469 for severe COVID-19 pneumonia, and NCT04463004 and NCT04492514 for COVID-19 pneumonia with systemic hyper-inflammation. These trials have been completed.
Yes, Mavrilimumab is also known as KPL-301. Clinical trials such as NCT03827018 and NCT04447469 refer to the drug as KPL-301, and it is being developed by Kiniksa Pharmaceuticals for the treatment of Giant Cell Arteritis and COVID-19.