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A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
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
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- RABI-767 (drug)
Sponsor: Panafina, Inc. · Participants: 36 · Started: Jun 28, 2024
Contact the study team
- Kelly Abernathy · Phone: 9194609500
Official record on ClinicalTrials.gov — NCT06080789
Locations in the U.S.
| Arkansas | University of Arkansas for Medical Sciences, Little Rock |
| California | Keck Hospital of USC and LA County Hospital, Los Angeles |
| Colorado | University of Colorado Anschutz Medical Campus, Aurora |
| Florida | University of Florida Health, Gainesville Orlando Health, Orlando |
| Illinois | UI Health, University of Illinois Chicago Hospital Health Sciences System, Chicago |
| Maryland | Johns Hopkins Hospital, Baltimore |
| Michigan | Henry Ford Hospital, Detroit |
| New Hampshire | Dartmouth Hitchcock Medical Center, Lebanon |
| New York | NYU Langone Medical Center, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.