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

Panafina

Status and phase

Enrolling

Phase 2

Conditions

Acute Pancreatitis

Treatments

Drug: RABI-767

Study type

Interventional

Funder types

Industry

Identifiers

NCT06080789

RABI-767-201

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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