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

NCT06080789 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RABI-767-201
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the study intervention, regardless of its causal relationship to the study intervention. For the purposes of this study, any AE occurring in any study participant (regardless of treatment group assignment) at any time after enrollment/randomization, even if no study intervention has been administered, will be recorded.

  Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)

• Number of Participants with Serious Adverse Events

  A serious adverse event (SAE) is an AE, regardless of causality, that fulfills one or more protocol defined criteria for being serious.

  Enrollment/Randomization to Day 35 Follow-up

• Change from Baseline in Clinical Chemistry Parameters

  Baseline to Day 7

• Change from Baseline in Hematology Parameters

  Baseline to Day 7

• Change from Baseline in Vital Signs

  Baseline to Day 7

• Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements

  Baseline to Day 7

Secondary Outcomes (16)

• Development of Severe Acute Pancreatitis

  Day 1 to Day 28 (or hospital discharge, if earlier)

• Development of New Onset Moderately Severe Acute Pancreatitis

  Day 1 to Day 28 (or hospital discharge, if earlier)

• Development of Pancreatic Necrosis

  Baseline to Day 60 Follow-up

• Development of Local Complications of Acute Pancreatitis

  Baseline to Day 60 Follow-up

• Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis

  Day 1 to Day 60 Follow-up

Study Arms (2)

RABI-767 plus Standard-of-Care

EXPERIMENTAL

Single-dose 125 mg RABI-767 plus standard-of-care

Drug: RABI-767

Standard-of-Care Only

NO INTERVENTION

No Intervention, Standard-of-Care Only

Interventions

RABI-767 DRUG

125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.

RABI-767 plus Standard-of-Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panafina, Inc.: lead

Study Sites (14)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Keck Hospital of USC and LA County Hospital

Los Angeles, California, 90033, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

University of Florida Health

Gainesville, Florida, 32608, United States

RECRUITING

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

UI Health, University of Illinois Chicago Hospital Health Sciences System

Chicago, Illinois, 60612, United States

RECRUITING

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

WITHDRAWN

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

NYU Langone Medical Center

New York, New York, 10016, United States

RECRUITING

Lisie Hospital

Kochi, Kerala, 682018, India

RECRUITING

Christian Medical College (CMC) Vellore, Ranipet Campus

Vellore, TamiNadu, 632517, India

RECRUITING

All India Institute of Medical Sciences

Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Kelly Abernathy

CONTACT

9194609500; kabernathy@arrivobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: June 28, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3); US (11)