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 was studied for the treatment of severe acute respiratory syndrome, specifically severe pulmonary disease related to COVID-19. It is an investigational monoclonal antibody developed by GSK and is not an approved therapy. Its clinical program focused on hospitalized adults with severe respiratory complications of the infection.
Otilimab targets CSF2, also known as granulocyte-macrophage colony-stimulating factor or GM-CSF. It is an inhibitor of this target. By binding CSF2, the monoclonal antibody is designed to interfere with the inflammatory signaling pathway driven by this cytokine, which is thought to contribute to severe lung inflammation.
Otilimab is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical program evaluating the monoclonal antibody in patients with severe respiratory disease, including the Phase 2 study conducted across multiple countries.
Otilimab is in Phase 2 development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 2 trial evaluating it in severe pulmonary COVID-19 related disease has been completed.
Otilimab was evaluated in one clinical trial, NCT04376684, titled Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease. This completed Phase 2 study was randomized, double-blind, and placebo-controlled, enrolling 1,156 adults aged 18 years and older across the United States, Europe, Latin America, Asia, and South Africa.