A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
Purpose
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.
Condition
- Acute Pancreatitis
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RABI-767 plus Standard-of-Care |
Single-dose 125 mg RABI-767 plus standard-of-care |
|
|
No Intervention Standard-of-Care Only |
No Intervention, Standard-of-Care Only |
|
Recruiting Locations
Little Rock 4119403, Arkansas 4099753 72205
Clinical Research Coordinator
501-526-4860
Los Angeles 5368361, California 5332921 90033
Clinical Research Coordinator
Aurora 5412347, Colorado 5417618 80045
Clinical Research Coordinator
303-724-1871
Gainesville 4156404, Florida 4155751 32608
Clinical Research Coordinator
352-273-9483
Orlando 4167147, Florida 4155751 32806
Clinical Research Coordinator
321-841-6649
Chicago 4887398, Illinois 4896861 60612
Clinical Research Coordinator
630-518-5456
Indianapolis 4259418, Indiana 4921868 46202
Clinical Research Coordinator
317-962-3586
Baltimore 4347778, Maryland 4361885 21287
Clinical Research Coordinator
410-614-6708
Lebanon 5088597, New Hampshire 5090174 03756
Clinical Research Coordinator
603-653-3651
New York 5128581, New York 5128638 10016
Clinical Research Coordinator
212-263-3095
More Details
- NCT ID
- NCT06080789
- Status
- Recruiting
- Sponsor
- Panafina, Inc.