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

Primary Purpose

Acute Pancreatitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
RABI-767
Sponsored by
Panafina, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 contrast-enhanced magnetic resonance imaging (CEMRI) 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 Pancreatic necrosis on screening CECT or CEMRI History of previous pancreatic necrosis, including necrosectomy History of calcific chronic pancreatitis Evidence of cholangitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    RABI-767 plus Standard-of-Care

    Standard-of-Care Only

    Arm Description

    Single-dose 125 mg RABI-767 plus standard-of-care

    No Intervention, Standard-of-Care Only

    Outcomes

    Primary Outcome Measures

    Number of Participants with Adverse Events
    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.
    Number of Participants with Serious Adverse Events
    A serious adverse event (SAE) is an AE, regardless of causality, that fulfills one or more protocol defined criteria for being serious.
    Change from Baseline in Clinical Chemistry Parameters
    Change from Baseline in Hematology Parameters
    Change from Baseline in Vital Signs
    Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements

    Secondary Outcome Measures

    Development of Severe Acute Pancreatitis
    Defined as >48 hours persistent organ failure
    Development of New Onset Moderately Severe Acute Pancreatitis
    Defined as transient organ failure and/or local or systemic complications without persistent organ failure
    Development of Pancreatic Necrosis
    As identified on CECT/CEMRI imaging; may be further sub-grouped into <30%, 30%-50%, and >50% pancreatic necrosis, if data allow.
    Development of Local Complications of Acute Pancreatitis
    As identified on CECT/CEMRI imaging; may be further sub-grouped by type of complication, if data allow.
    Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis
    Death caused by acute pancreatitis and/or complications secondary to acute pancreatitis
    Mortality due to any cause
    Death due to any cause
    Days in Hospital
    Re-hospitalization for acute pancreatitis or related complications
    Number of participants re-hospitalized for acute pancreatitis or related complications out of total participants who are discharged.
    Length of Stay in Intensive Care Unit
    Development of New Onset Infection
    May be further sub-grouped by: pancreatic, peripancreatic, and extra-pancreatic infections, as data allow.
    Change in Modified Marshall Score
    Change in Sequential Organ Failure Assessment (SOFA) Score
    Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment
    Change in Abdominal Pain Numeric Rating Score
    Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis
    Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis

    Full Information

    First Posted
    October 8, 2023
    Last Updated
    October 8, 2023
    Sponsor
    Panafina, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06080789
    Brief Title
    A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Panafina, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pancreatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RABI-767 plus Standard-of-Care
    Arm Type
    Experimental
    Arm Description
    Single-dose 125 mg RABI-767 plus standard-of-care
    Arm Title
    Standard-of-Care Only
    Arm Type
    No Intervention
    Arm Description
    No Intervention, Standard-of-Care Only
    Intervention Type
    Drug
    Intervention Name(s)
    RABI-767
    Intervention Description
    125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
    Primary Outcome Measure Information:
    Title
    Number of Participants with Adverse Events
    Description
    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.
    Time Frame
    Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)
    Title
    Number of Participants with Serious Adverse Events
    Description
    A serious adverse event (SAE) is an AE, regardless of causality, that fulfills one or more protocol defined criteria for being serious.
    Time Frame
    Enrollment/Randomization to Day 35 Follow-up
    Title
    Change from Baseline in Clinical Chemistry Parameters
    Time Frame
    Baseline to Day 7
    Title
    Change from Baseline in Hematology Parameters
    Time Frame
    Baseline to Day 7
    Title
    Change from Baseline in Vital Signs
    Time Frame
    Baseline to Day 7
    Title
    Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements
    Time Frame
    Baseline to Day 7
    Secondary Outcome Measure Information:
    Title
    Development of Severe Acute Pancreatitis
    Description
    Defined as >48 hours persistent organ failure
    Time Frame
    Day 1 to Day 28 (or hospital discharge, if earlier)
    Title
    Development of New Onset Moderately Severe Acute Pancreatitis
    Description
    Defined as transient organ failure and/or local or systemic complications without persistent organ failure
    Time Frame
    Day 1 to Day 28 (or hospital discharge, if earlier)
    Title
    Development of Pancreatic Necrosis
    Description
    As identified on CECT/CEMRI imaging; may be further sub-grouped into <30%, 30%-50%, and >50% pancreatic necrosis, if data allow.
    Time Frame
    Baseline to Day 60 Follow-up
    Title
    Development of Local Complications of Acute Pancreatitis
    Description
    As identified on CECT/CEMRI imaging; may be further sub-grouped by type of complication, if data allow.
    Time Frame
    Baseline to Day 60 Follow-up
    Title
    Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis
    Description
    Death caused by acute pancreatitis and/or complications secondary to acute pancreatitis
    Time Frame
    Day 1 to Day 60 Follow-up
    Title
    Mortality due to any cause
    Description
    Death due to any cause
    Time Frame
    Day 1 to Day 60 Follow-up
    Title
    Days in Hospital
    Time Frame
    Day 1 through Day 28 (or hospital discharge, if earlier)
    Title
    Re-hospitalization for acute pancreatitis or related complications
    Description
    Number of participants re-hospitalized for acute pancreatitis or related complications out of total participants who are discharged.
    Time Frame
    From initial hospital discharge to Day 35 Follow-up
    Title
    Length of Stay in Intensive Care Unit
    Time Frame
    Day 1 through Day 28 (or hospital discharge, if earlier)
    Title
    Development of New Onset Infection
    Description
    May be further sub-grouped by: pancreatic, peripancreatic, and extra-pancreatic infections, as data allow.
    Time Frame
    Day 1 to Day 28 (or hospital discharge, if earlier)
    Title
    Change in Modified Marshall Score
    Time Frame
    From Baseline through Day 28 (or hospital discharge, if earlier)
    Title
    Change in Sequential Organ Failure Assessment (SOFA) Score
    Time Frame
    From Baseline through Day 28 (or hospital discharge, if earlier)
    Title
    Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment
    Time Frame
    From Baseline through Day 28 (or hospital discharge, if earlier)
    Title
    Change in Abdominal Pain Numeric Rating Score
    Time Frame
    From Baseline through Day 28 (or hospital discharge, if earlier)
    Title
    Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis
    Time Frame
    From Baseline through Day 60 Follow-up
    Title
    Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis
    Time Frame
    From Baseline through Day 60 Follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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 contrast-enhanced magnetic resonance imaging (CEMRI) 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 Pancreatic necrosis on screening CECT or CEMRI History of previous pancreatic necrosis, including necrosectomy History of calcific chronic pancreatitis Evidence of cholangitis

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan to make individual participant data (IPD) available to other researchers.

    Learn more about this trial

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

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