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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080789
• Other study ID #: RABI-767-201
• Status: Recruiting
• Phase: Phase 2
• Start date: February 26, 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Panafina, Inc.
• Contact: Kelly Abernathy
• Phone: 9194609500
• Email: kabernathy[@]arrivobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Drug:
• RABI-767
125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.

Locations

Country	Name	City	State
United States	University fo Florida Health	Gainesville	Florida
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Keck Hospital of USC and LA County Hospital	Los Angeles	California
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Panafina, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	Change from Baseline in Clinical Chemistry Parameters		Baseline to Day 7
Primary	Change from Baseline in Hematology Parameters		Baseline to Day 7
Primary	Change from Baseline in Vital Signs		Baseline to Day 7
Primary	Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements		Baseline to Day 7
Secondary	Development of Severe Acute Pancreatitis	Defined as >48 hours persistent organ failure	Day 1 to Day 28 (or hospital discharge, if earlier)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality due to any cause	Death due to any cause	Day 1 to Day 60 Follow-up
Secondary	Days in Hospital		Day 1 through Day 28 (or hospital discharge, if earlier)
Secondary	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
Secondary	Length of Stay in Intensive Care Unit		Day 1 through Day 28 (or hospital discharge, if earlier)
Secondary	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)
Secondary	Change in Modified Marshall Score		From Baseline through Day 28 (or hospital discharge, if earlier)
Secondary	Change in Sequential Organ Failure Assessment (SOFA) Score		From Baseline through Day 28 (or hospital discharge, if earlier)
Secondary	Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment		From Baseline through Day 28 (or hospital discharge, if earlier)
Secondary	Change in Abdominal Pain Numeric Rating Score		From Baseline through Day 28 (or hospital discharge, if earlier)
Secondary	Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis		From Baseline through Day 60 Follow-up
Secondary	Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis		From Baseline through Day 60 Follow-up