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

Purpose

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.

Condition

  • Acute Pancreatitis

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
RABI-767 plus Standard-of-Care 		Single-dose 125 mg RABI-767 plus standard-of-care
  • Drug: RABI-767
    125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
No Intervention
Standard-of-Care Only 		No Intervention, Standard-of-Care Only

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Clinical Research Coordinator
501-526-4860

Keck Hospital of USC and LA County Hospital
Los Angeles, California 90033
Contact:
Clinical Research Coordinator

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
Contact:
Clinical Research Coordinator
303-724-1871

University of Florida Health
Gainesville, Florida 32608
Contact:
Clinical Research Coordinator
352-273-9483

Orlando Health
Orlando, Florida 32806
Contact:
Clinical Research Coordinator
321-841-6649

UI Health, University of Illinois Chicago Hospital Health Sciences System
Chicago, Illinois 60612
Contact:
Clinical Research Coordinator
630-518-5456

Indiana University Health University Hospital
Indianapolis, Indiana 46202
Contact:
Clinical Research Coordinator
317-962-3586

Johns Hopkins Hospital
Baltimore, Maryland 21287
Contact:
Clinical Research Coordinator
410-614-6708

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Clinical Research Coordinator
603-653-3651

NYU Langone Medical Center
New York, New York 10016
Contact:
Clinical Research Coordinator
212-263-3095

More Details

NCT ID
NCT06080789
Status
Recruiting
Sponsor
Panafina, Inc.

Study Contact

Kelly Abernathy
9194609500
kabernathy@arrivobio.com