The goal of this clinical trial is to test the safety and effectiveness of a single dose of RABI-767 given by endoscopic ultrasound (EUS) guided peripancreatic injection in participants with predicted severe acute pancreatitis.
The main question the study aims to answer is:
• Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection safe in patients with predicted severe acute pancreatitis.
The study also aims to answer:
• Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis.
Study participants will be randomly assigned (like the flip of a coin) to receive a single dose of RABI-767 plus supportive care or supportive care only.
The study sponsor will compare safety and efficacy data collected from participants who receive RABI-767 to participants who receive supportive care only to test if RABI-767 is safe and effective.
Diagnosis of acute pancreatitis
Predicted severe acute pancreatitis, based on protocol defined criteria
Lack of clinically meaningful improvement from status at admission, at the discretion of Investigator, at the time of randomization
Suitable for EUS-guided study drug administration procedure
Confirmed severe acute pancreatitis as defined by the Revised Atlanta Classification of Acute Pancreatitis (ie, Persistent [> 48 hours] organ failure, per Modified Marshall Score), prior to randomization
Anticipated discharge from hospital within 48 hours of randomization
More than 30% pancreatic necrosis on screening CECT or MRI
History of previous pancreatic necrosis, including necrosectomy
Parallel
RABI-767
Drug125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the study intervention, regardless of its causal relationship to the study intervention. For the purposes of this study, any AE occurring in any study participant (regardless of treatment group assignment) at any time after enrollment/randomization, even if no study intervention has been administered, will be recorded.
Number of Participants with Serious Adverse Events
A serious adverse event (SAE) is an AE, regardless of causality, that fulfills one or more protocol defined criteria for being serious.
Change from Baseline in Clinical Chemistry Parameters
Change from Baseline in Hematology Parameters
Development of Severe Acute Pancreatitis
Defined as \>48 hours persistent organ failure
Development of New Onset Moderately Severe Acute Pancreatitis
Defined as transient organ failure and/or local or systemic complications without persistent organ failure
Development of Pancreatic Necrosis
As identified on CECT/CEMRI imaging; may be further sub-grouped into \<30%, 30%-50%, and \>50% pancreatic necrosis, if data allow.
Development of Local Complications of Acute Pancreatitis
As identified on CECT/CEMRI imaging; may be further sub-grouped by type of complication, if data allow.
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