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

Description

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.

Conditions

Acute Pancreatitis

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Study Overview

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Study Details

Study overview

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.

A Phase 2a, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 Administered by Endoscopic Ultrasound-Guided Peripancreatic Injection Plus Standard-of-Care Versus Standard-of-Care Only in Participants with Predicted Severe Acute Pancreatitis

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

Condition
Acute Pancreatitis
Intervention / Treatment

-

Contacts and Locations

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Los Angeles

Keck Hospital of USC and LA County Hospital, Los Angeles, California, United States, 90033

Gainesville

University of Florida Health, Gainesville, Florida, United States, 32608

Orlando

Orlando Health, Orlando, Florida, United States, 32806

Chicago

UI Health, University of Illinois Chicago Hospital Health Sciences System, Chicago, Illinois, United States, 60612

Indianapolis

Indiana University Health University Hospital, Indianapolis, Indiana, United States, 46202

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Lebanon

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03756

New York

NYU Langone Medical Center, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Panafina, Inc.,

Study Record Dates

2025-10