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

August 3, 2026 updated by: Panafina, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Chandigarh, India
        • Recruiting
        • Postgraduate Institute of Medical Education and Research
        • Contact:
          • Clinical research coordinator
        • Contact:
          • Phone Number: (+91) 9015143233
      • Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: +91 941-160-2782
      • New Delhi, India, 110002
        • Recruiting
        • Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
        • Contact:
          • Clinical research coordinator
        • Contact:
          • Phone Number: +91 6205261118
    • Kerala
      • Kochi, Kerala, India, 682018
        • Recruiting
        • Lisie Hospital
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: +91 859-095-8869
    • TamiNadu
      • Vellore, TamiNadu, India, 632517
        • Recruiting
        • Christian Medical College (CMC) Vellore, Ranipet Campus
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: +91 987-249-3649
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 501-526-4860
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Hospital of USC and LA County Hospital
        • Contact:
          • Clinical research coordinator
        • Contact:
          • Phone Number: 323-409-6939
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 303-724-1871
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida Health
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 352-273-9483
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 321-841-6649
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • UI Health, University of Illinois Chicago Hospital Health Sciences System
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 630-518-5456
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Withdrawn
        • Indiana University Health University Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 410-614-6708
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 313-746-8215
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 603-653-3651
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 212-263-3095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)
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
Time Frame: Enrollment/Randomization to Day 35 Follow-up
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
Time Frame: Baseline to Day 7
Baseline to Day 7
Change from Baseline in Hematology Parameters
Time Frame: Baseline to Day 7
Baseline to Day 7
Change from Baseline in Vital Signs
Time Frame: Baseline to Day 7
Baseline to Day 7
Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements
Time Frame: Baseline to Day 7
Baseline to Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Severe Acute Pancreatitis
Time Frame: Day 1 to Day 28 (or hospital discharge, if earlier)
Defined as >48 hours persistent organ failure
Day 1 to Day 28 (or hospital discharge, if earlier)
Development of New Onset Moderately Severe Acute Pancreatitis
Time Frame: Day 1 to Day 28 (or hospital discharge, if earlier)
Defined as transient organ failure and/or local or systemic complications without persistent organ failure
Day 1 to Day 28 (or hospital discharge, if earlier)
Development of Pancreatic Necrosis
Time Frame: Baseline to Day 60 Follow-up
As identified on CECT/CEMRI imaging; may be further sub-grouped into <30%, 30%-50%, and >50% pancreatic necrosis, if data allow.
Baseline to Day 60 Follow-up
Development of Local Complications of Acute Pancreatitis
Time Frame: Baseline to Day 60 Follow-up
As identified on CECT/CEMRI imaging; may be further sub-grouped by type of complication, if data allow.
Baseline to Day 60 Follow-up
Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis
Time Frame: Day 1 to Day 60 Follow-up
Death caused by acute pancreatitis and/or complications secondary to acute pancreatitis
Day 1 to Day 60 Follow-up
Mortality due to any cause
Time Frame: Day 1 to Day 60 Follow-up
Death due to any cause
Day 1 to Day 60 Follow-up
Days in Hospital
Time Frame: Day 1 through Day 28 (or hospital discharge, if earlier)
Day 1 through Day 28 (or hospital discharge, if earlier)
Re-hospitalization for acute pancreatitis or related complications
Time Frame: From initial hospital discharge to Day 35 Follow-up
Number of participants re-hospitalized for acute pancreatitis or related complications out of total participants who are discharged.
From initial hospital discharge to Day 35 Follow-up
Length of Stay in Intensive Care Unit
Time Frame: Day 1 through Day 28 (or hospital discharge, if earlier)
Day 1 through Day 28 (or hospital discharge, if earlier)
Development of New Onset Infection
Time Frame: Day 1 to Day 28 (or hospital discharge, if earlier)
May be further sub-grouped by: pancreatic, peripancreatic, and extra-pancreatic infections, as data allow.
Day 1 to Day 28 (or hospital discharge, if earlier)
Change in Modified Marshall Score
Time Frame: From Baseline through Day 28 (or hospital discharge, if earlier)
From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Sequential Organ Failure Assessment (SOFA) Score
Time Frame: From Baseline through Day 28 (or hospital discharge, if earlier)
From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment
Time Frame: From Baseline through Day 28 (or hospital discharge, if earlier)
From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Abdominal Pain Numeric Rating Score
Time Frame: From Baseline through Day 28 (or hospital discharge, if earlier)
From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis
Time Frame: From Baseline through Day 60 Follow-up
From Baseline through Day 60 Follow-up
Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis
Time Frame: From Baseline through Day 60 Follow-up
From Baseline through Day 60 Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Panafina, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RABI-767-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe