NCT06080789 A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
| NCT ID | NCT06080789 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Panafina, Inc. |
| Condition | Acute Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2024-06-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06080789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Acute Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06080789 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06080789 currently recruiting?
Yes, NCT06080789 is actively recruiting participants. Contact the research team at kabernathy@arrivobio.com for enrollment information.
Where is the NCT06080789 trial being conducted?
This trial is being conducted at Little Rock, United States, Los Angeles, United States, Aurora, United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT06080789 clinical trial?
NCT06080789 is sponsored by Panafina, Inc.. The trial plans to enroll 36 participants.