Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Otilimab · 1 trial · 1 indication
Participants were considered alive and free of respiratory failure if they were in category 1, 2, 3, or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale was as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized,limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, highflow oxygen (greater than or equal to \[\>=\]15 liters per minute \[L/min\]), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death. Higher scale indicates higher intensity of respiratory failure. Percentage values are rounded off.
Participants were alive and free of respiratory failure if they were in category 1, 2, 3 or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale was as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized,limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, highflow oxygen (\>=15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death. Higher scale indicates higher intensity of respiratory failure. Percentage values are rounded off.
| Arm | Type | Description |
|---|---|---|
| Part 1: Participants receiving otilimab | EXPERIMENTAL | Participants (age \>=18 years and \<=79 years) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 1. |
| Part 1: Participants receiving placebo 1 | PLACEBO_COMPARATOR | Participants (age \>=18 years and \<=79 years) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 1. |
| Part 2: Participants receiving otilimab | EXPERIMENTAL | Participants (age 70 years or above) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 2. |
| Part 2: Participants receiving placebo 2 | PLACEBO_COMPARATOR | Participants (age 70 years or above) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 2. |
| Name | Type | Description |
|---|---|---|
| Otilimab | BIOLOGICAL | Otilimab will be administered once via IV route. |
| Placebo 1 | BIOLOGICAL | Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route. |
| Placebo 2 | BIOLOGICAL | Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route. |
| Standard of care | DRUG | All participants will receive standard of care as per institutional protocol. |
Inclusion criteria for Part 1: * Participants aged \>=18 years and \<=79 years at the time of obtaining informed consent. * Participants must: 1. have positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) result (any validated test, for example. reverse transcription polymerase c...
Otilimab is an investigational monoclonal antibody being studied for the treatment of Severe Acute Respiratory Syndrome, specifically in patients with severe pulmonary COVID-19 related disease. It is being developed by GSK plc and is currently in Phase 2 clinical development.
Otilimab is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is investigating this monoclonal antibody as a potential treatment for Severe Acute Respiratory Syndrome.
Otilimab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to evaluate its safety and efficacy in patients with severe pulmonary COVID-19 related disease.
Otilimab has been studied in one completed Phase 2 clinical trial with the identifier NCT04376684. This trial, titled "Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease," enrolled 1156 participants across multiple countries including the United States, United Kingdom, and Japan.
Yes, Otilimab is a monoclonal antibody. It is being investigated as a therapeutic option for Severe Acute Respiratory Syndrome, with a completed Phase 2 trial that was randomized, double-blind, and placebo-controlled, enrolling 1156 patients.