NCT06080789PHASE2Recruiting

A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis

Panafina, Inc.

Start Date

6/28/2024

Completion Date

12/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to 85 years

Key Inclusion Criteria: * 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 * Contrast-enhanced computed tomography (CECT) or magnetic resonance imaging (MRI) of the abdomen/pancreas available for the evaluation of exclusion criteria Key Exclusion Criteria: * 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 * History of calcific chronic pancreatitis * Evidence of cholangitis

Interventions

DRUG

RABI-767