Evaluating RABI-767 for treating severe acute pancreatitis
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
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 |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Panafina, Inc. Industry-sponsored |
| Locations | 15 sites (Little Rock, Arkansas and 14 other locations) |
| Trial ID | NCT06080789 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is novel, similar studies have shown promise in evaluating new treatments for acute pancreatitis.
Eligibility criteria
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 this trial is running
Little Rock, Arkansas and 14 other locations
- 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)
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (Withdrawn)
- 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)
- All India Institute of Medical Sciences — Delhi, India (Recruiting)
- Govind Ballabh Pant Institute of Postgraduate Medical Education and Research — New Delhi, India (Recruiting)
Study contacts
- Study coordinator: Kelly Abernathy
- Email: kabernathy@arrivobio.com
- Phone: 9194609500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.