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CERC-002 · 1 trial · 3 indications
Respiratory failure defined based on resource utilization requiring at least one of the following: * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥0.5) * Noninvasive positive pressure ventilation, * Extracorporeal membrane oxygenation
| Arm | Type | Description |
|---|---|---|
| CERC-002 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CERC-002 | DRUG | Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg. |
| Placebo | DRUG | Administered once subcutaneously |
Inclusion Criteria: 1. Subject/legally authorized representative (LAR) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study. 2. Subject is ≥18 years of age at the time of informed consent and assent (as applicable). 3. Subject is male o...
CERC-002 is an investigational small molecule being developed for COVID-19 pneumonia, including patients with acute lung injury and ARDS. It was studied in a Phase 2 clinical trial in adults aged 18 and older in the United States. It is not an approved therapy.
CERC-002 targets LIGHT, a cytokine. By binding to this cytokine target, the drug is designed to modulate the inflammatory signaling associated with severe respiratory disease in COVID-19 pneumonia and acute lung injury.
CERC-002 is being developed by Avalo Therapeutics, Inc., which trades under the ticker AVTX. The company is the sponsor of the clinical program evaluating the drug in COVID-19 pneumonia and acute lung injury.
CERC-002 is in Phase 2 development. It is an investigational drug and has not been approved by the FDA. The Phase 2 study has been completed, and no trials are currently active.
CERC-002 was evaluated in one clinical trial, NCT04412057, titled a clinical trial to evaluate CERC-002 in adults with COVID-19 pneumonia and acute lung injury. The Phase 2 study was completed, enrolled 88 participants, and was randomized, double-blind, and placebo-controlled.