Clinical trial Recruiting at 15 sites Phase 2 Interventional Ages 18 to 85

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

PhasePhase 2
Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment36 (estimated)
SponsorPanafina, Inc.
Industry-sponsored
Locations16 sites (Little Rock, Arkansas and 15 other locations)
StatusRecruiting
StartedJune 28, 2024
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedAugust 5, 2026
Trial IDNCT06080789 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.