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NCT Number: NCT06080789

A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lisie Hospital, Kochi, Kerala, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RABI-767

Drug

125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the study intervention, regardless of its causal relationship to the study intervention. For the purposes of this study, any AE occurring in any study participant (regardless of treatment group assignment) at any time after enrollment/randomization, even if no study intervention has been administered, will be recorded.

  2. Number of Participants with Serious Adverse Events

    Time frame: Enrollment/Randomization to Day 35 Follow-up

    A serious adverse event (SAE) is an AE, regardless of causality, that fulfills one or more protocol defined criteria for being serious.

  3. Change from Baseline in Clinical Chemistry Parameters

    Time frame: Baseline to Day 7

  4. Change from Baseline in Hematology Parameters

    Time frame: Baseline to Day 7

  5. Change from Baseline in Vital Signs

    Time frame: Baseline to Day 7

  6. Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements

    Time frame: Baseline to Day 7

Secondary outcomes

  1. Development of Severe Acute Pancreatitis

    Time frame: Day 1 to Day 28 (or hospital discharge, if earlier)

    Defined as >48 hours persistent organ failure

  2. Development of New Onset Moderately Severe Acute Pancreatitis

    Time frame: Day 1 to Day 28 (or hospital discharge, if earlier)

    Defined as transient organ failure and/or local or systemic complications without persistent organ failure

  3. Development of Pancreatic Necrosis

    Time frame: Baseline to Day 60 Follow-up

    As identified on CECT/CEMRI imaging; may be further sub-grouped into <30%, 30%-50%, and >50% pancreatic necrosis, if data allow.

  4. Development of Local Complications of Acute Pancreatitis

    Time frame: Baseline to Day 60 Follow-up

    As identified on CECT/CEMRI imaging; may be further sub-grouped by type of complication, if data allow.

  5. Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis

    Time frame: Day 1 to Day 60 Follow-up

    Death caused by acute pancreatitis and/or complications secondary to acute pancreatitis

  6. Mortality due to any cause

    Time frame: Day 1 to Day 60 Follow-up

    Death due to any cause

  7. Days in Hospital

    Time frame: Day 1 through Day 28 (or hospital discharge, if earlier)

  8. Re-hospitalization for acute pancreatitis or related complications

    Time frame: From initial hospital discharge to Day 35 Follow-up

    Number of participants re-hospitalized for acute pancreatitis or related complications out of total participants who are discharged.

  9. Length of Stay in Intensive Care Unit

    Time frame: Day 1 through Day 28 (or hospital discharge, if earlier)

  10. Development of New Onset Infection

    Time frame: Day 1 to Day 28 (or hospital discharge, if earlier)

    May be further sub-grouped by: pancreatic, peripancreatic, and extra-pancreatic infections, as data allow.

  11. Change in Modified Marshall Score

    Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)

  12. Change in Sequential Organ Failure Assessment (SOFA) Score

    Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)

  13. Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment

    Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)

  14. Change in Abdominal Pain Numeric Rating Score

    Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)

  15. Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis

    Time frame: From Baseline through Day 60 Follow-up

  16. Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis

    Time frame: From Baseline through Day 60 Follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Abernathy

CONTACT

[email protected]

9194609500

Sponsors and collaborators

Lead sponsor

Panafina, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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