Evaluating RABI-767 for treating severe 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
Run by Panafina, Inc. · NCT06080789 · Data updated 2026-11-12
This study is testing if a new treatment called RABI-767 can help people with severe acute pancreatitis feel better when given through a special injection.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Panafina, Inc. Industry-sponsored |
| Locations | 16 sites (Little Rock, Arkansas and 15 other locations) |
| Status | Recruiting |
| Started | June 28, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT06080789 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with acute pancreatitis who are predicted to have a severe case and are suitable for EUS-guided injection.
✕Probably not a fit
Patients with confirmed severe acute pancreatitis or those who are expected to be discharged from the hospital within 48 hours may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the safety and efficacy of a single dose of RABI-767 administered via endoscopic ultrasound (EUS) guided peripancreatic injection in patients with predicted severe acute pancreatitis. Participants will be randomly assigned to receive either RABI-767 along with supportive care or supportive care alone. The study will compare the outcomes of both groups to determine if RABI-767 is a safe and effective treatment option for this condition.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from severe acute pancreatitis.
How similar studies have gone: While this approach is novel, similar studies have shown promise in evaluating new treatments for acute pancreatitis.
Who can join: the full rules
Show full inclusion / 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
Where it's running
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States Recruiting -
Keck Hospital of USC and LA County Hospital
Los Angeles, California, United States Recruiting -
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States Recruiting -
University of Florida Health
Gainesville, Florida, United States Recruiting -
Orlando Health
Orlando, Florida, United States Recruiting -
UI Health, University of Illinois Chicago Hospital Health Sciences System
Chicago, Illinois, United States Recruiting
Show 10 more locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting -
Henry Ford Hospital
Detroit, Michigan, United States Recruiting -
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting -
NYU Langone Medical Center
New York, New York, United States Recruiting -
Lisie Hospital
Kochi, Kerala, India Recruiting -
Christian Medical College (CMC) Vellore, Ranipet Campus
Vellore, TamiNadu, India Recruiting -
Postgraduate Institute of Medical Education and Research
Chandigarh, India Recruiting -
All India Institute of Medical Sciences
Delhi, India Recruiting -
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
New Delhi, India Recruiting -
Indiana University Health University Hospital
Indianapolis, Indiana, United States Withdrawn
Study contacts
- Study coordinator: Kelly Abernathy
- Email: kabernathy@arrivobio.com
- Phone: 9194609500
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Local complications of acute pancreatitis and postoperative pancreatic fistula: what happens in real life
This multicenter registry tests how local pancreatic complications are managed in routine care and what outcomes look like over 180 days for adults.
-
SGC001 is being tested to help predicted severe acute pancreatitis
Researchers are testing SGC001 vs placebo in adults with predicted severe acute pancreatitis to see if it is safe and tolerable and to get a sense of any early effects.
-
Fecal microbiota transplant to prevent infections after late-phase severe acute pancreatitis
This trial will test whether giving healthy donor gut bacteria (fecal microbiota transplantation) through a feeding tube in the late phase of moderately severe or severe acute pancreatitis can prevent infectious complications.
-
How often splanchnic vein clots occur in acute pancreatitis and whether they relate to disease severity
This project will see if people with acute pancreatitis develop blood clots in the splenic, portal, or superior mesenteric veins and whether those clots are linked to more severe illness.
-
Fecal microbiota transplant for people with moderate to severe acute pancreatitis
This trial will test whether a fecal microbiota transplant (FMT) can reduce late complications in adults with moderate to severe acute pancreatitis.
-
Blood markers to detect infected pancreatic necrosis
We will test whether specific blood markers can help predict or diagnose infected pancreatic necrosis in adults with necrotizing pancreatitis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.