Clinical trial NCT06080789: A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Pancreatitis
Lead sponsor: Panafina, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)
measure: Number of Participants with Serious Adverse Events
timeFrame: Enrollment/Randomization to Day 35 Follow-up
measure: Change from Baseline in Clinical Chemistry Parameters
timeFrame: Baseline to Day 7
measure: Change from Baseline in Hematology Parameters
timeFrame: Baseline to Day 7
measure: Change from Baseline in Vital Signs
timeFrame: Baseline to Day 7
measure: Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements
timeFrame: Baseline to Day 7
Secondary outcomes:
measure: Development of Severe Acute Pancreatitis
timeFrame: Day 1 to Day 28 (or hospital discharge, if earlier)
measure: Development of New Onset Moderately Severe Acute Pancreatitis
timeFrame: Day 1 to Day 28 (or hospital discharge, if earlier)
measure: Development of Pancreatic Necrosis
timeFrame: Baseline to Day 60 Follow-up
measure: Development of Local Complications of Acute Pancreatitis
timeFrame: Baseline to Day 60 Follow-up
measure: Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis
timeFrame: Day 1 to Day 60 Follow-up
measure: Mortality due to any cause
timeFrame: Day 1 to Day 60 Follow-up
measure: Days in Hospital
timeFrame: Day 1 through Day 28 (or hospital discharge, if earlier)
measure: Re-hospitalization for acute pancreatitis or related complications
timeFrame: From initial hospital discharge to Day 35 Follow-up
measure: Length of Stay in Intensive Care Unit
timeFrame: Day 1 through Day 28 (or hospital discharge, if earlier)
measure: Development of New Onset Infection
timeFrame: Day 1 to Day 28 (or hospital discharge, if earlier)
measure: Change in Modified Marshall Score
timeFrame: From Baseline through Day 28 (or hospital discharge, if earlier)
measure: Change in Sequential Organ Failure Assessment (SOFA) Score
timeFrame: From Baseline through Day 28 (or hospital discharge, if earlier)
measure: Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment
timeFrame: From Baseline through Day 28 (or hospital discharge, if earlier)
measure: Change in Abdominal Pain Numeric Rating Score
timeFrame: From Baseline through Day 28 (or hospital discharge, if earlier)
measure: Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis
timeFrame: From Baseline through Day 60 Follow-up
measure: Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis
timeFrame: From Baseline through Day 60 Follow-up
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: Keck Hospital of USC and LA County Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Chicago
country: United States
facility: UI Health, University of Illinois Chicago Hospital Health Sciences System
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
References: