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

Last updated: February 19, 2025
Sponsor: Panafina, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatitis

Treatment

RABI-767

Clinical Study ID

NCT06080789
RABI-767-201
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thediscretion 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) ofthe abdomen/pancreas available for the evaluation of exclusion criteria

Exclusion

Key Exclusion Criteria:

  • Confirmed severe acute pancreatitis as defined by the Revised Atlanta Classificationof Acute Pancreatitis (ie, Persistent [> 48 hours] organ failure, per ModifiedMarshall 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

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: RABI-767
Phase: 2
Study Start date:
June 28, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Keck Hospital of USC and LA County Hospital

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University fo Florida Health

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • University of Florida Health

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • Orlando Health

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • UI Health, University of Illinois Chicago Hospital Health Sciences System

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Active - Recruiting

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