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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

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
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

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

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.