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

J
John DeWitt, MD

Primary Investigator

Enrolling By Invitation
18 years - 85 years
All
Phase 2
3 participants needed
1 Location

Brief description of study

What is the goal of this 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.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

What will happen during the study?
  • 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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute pancreatitis
  • Age: 18 years - 85 years
  • Gender: All

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 contrast-enhanced magnetic resonance imaging (CEMRI) 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
  • Pancreatic necrosis on screening CECT or CEMRI
  • History of previous pancreatic necrosis, including necrosectomy
  • History of calcific chronic pancreatitis
  • Evidence of cholangitis

 

Updated on 03 Jun 2025. Study ID: ECRO-PANAFINA-RABI-767, 26987
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting referrals by invitation only