RABI-767 for Acute Pancreatitis

Recruiting at 10 trial locations

Overseen By Kelly Abernathy

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Panafina, Inc.

Disqualifiers: Severe pancreatitis, Pancreatic necrosis, Cholangitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the purpose of this trial?

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

This trial is for people with severe acute pancreatitis, confirmed by specific imaging tests (CECT or CEMRI), who haven't improved significantly since being admitted to the hospital. Participants must be suitable for a procedure that uses an endoscope to deliver the study drug near the pancreas.

Inclusion Criteria

I have been diagnosed with acute pancreatitis.

Lack of clinically meaningful improvement from status at admission, at the discretion of Investigator, at the time of randomization

I am at high risk for severe acute pancreatitis.

Exclusion Criteria

Anticipated discharge from hospital within 48 hours of randomization

I have been diagnosed with severe acute pancreatitis.

My pancreas has areas of dead tissue seen on a special scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of RABI-767 via EUS-guided peripancreatic injection plus standard-of-care or standard-of-care only

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Multiple visits (in-person and/or virtual)

Treatment Details

Interventions

• RABI-767

Trial Overview The trial is testing RABI-767, administered once via an endoscopic ultrasound around the pancreas, against supportive care alone. The goal is to see if this single dose can safely and effectively treat severe acute pancreatitis.

Participant Groups

Group I: RABI-767 plus Standard-of-Care Experimental Treatment 1 Intervention

Single-dose 125 mg RABI-767 plus standard-of-care

Group II: Standard-of-Care Only Active Control 1 Intervention

No Intervention, Standard-of-Care Only

RABI-767 is already approved in United States for the following indications:

Approved in United States as RABI-767 for:

• None - Currently under investigation for acute pancreatitis, not yet approved

Who Is Running the Clinical Trial?

Panafina, Inc.

Lead Sponsor

Trials

1

Recruited

40+