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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Drug: RABI-767


Participation Criteria
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Eligibility Criteria
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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 contrast-enhanced magnetic resonance imaging (CEMRI) 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 Pancreatic necrosis on screening CECT or CEMRI History of previous pancreatic necrosis, including necrosectomy History of calcific chronic pancreatitis Evidence of cholangitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RABI-767 plus Standard-of-Care<br>Single-dose 125 mg RABI-767 plus standard-of-care | Drug: RABI-767<br>* 125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.<br>|
| No Intervention: Standard-of-Care Only<br>No Intervention, Standard-of-Care Only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Severe Acute Pancreatitis | 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 | 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 | 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 | 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 | Death caused by acute pancreatitis and/or complications secondary to acute pancreatitis | Day 1 to Day 60 Follow-up | 
| Mortality due to any cause | Death due to any cause | Day 1 to Day 60 Follow-up | 
| Days in Hospital |  | Day 1 through Day 28 (or hospital discharge, if earlier) | 
| Re-hospitalization for acute pancreatitis or related complications | 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 |  | Day 1 through Day 28 (or hospital discharge, if earlier) | 
| Development of New Onset Infection | 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 |  | From Baseline through Day 28 (or hospital discharge, if earlier) | 
| Change in Sequential Organ Failure Assessment (SOFA) Score |  | From Baseline through Day 28 (or hospital discharge, if earlier) | 
| Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment |  | From Baseline through Day 28 (or hospital discharge, if earlier) | 
| Change in Abdominal Pain Numeric Rating Score |  | From Baseline through Day 28 (or hospital discharge, if earlier) | 
| Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis |  | From Baseline through Day 60 Follow-up | 
| Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis |  | From Baseline through Day 60 Follow-up |