Acute PancreatitisPhase 2NCT06080789
A Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 in Participants With Acute Pancreatitis
A Phase 2 study testing RABI-767 in people with Acute Pancreatitis, run by Panafina, Inc. at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- RABI-767
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 28 Jun 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
United States11 sites, 10 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Clinical Research Coordinator, 303-724-1871
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Clinical Research Coordinator, 410-614-6708
- Recruiting
UI Health, University of Illinois Chicago Hospital Health Sciences System
Chicago, Illinois, 60612
Clinical Research Coordinator, 630-518-5456
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Clinical Research Coordinator, 313-746-8215
- Recruiting
University of Florida Health
Gainesville, Florida, 32608
Clinical Research Coordinator, 352-273-9483
- Withdrawn
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Clinical Research Coordinator, 603-653-3651
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Clinical Research Coordinator, 501-526-4860
- Recruiting
Keck Hospital of USC and LA County Hospital
Los Angeles, California, 90033
Clinical Research Coordinator
323-409-6939
- Recruiting
NYU Langone Medical Center
New York, New York, 10016
Clinical Research Coordinator, 212-263-3095
- Recruiting
Orlando Health
Orlando, Florida, 32806
Clinical Research Coordinator, 321-841-6649
India5 sites, 5 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh
Clinical Research Coordinator
(+91) 9015143233
- Recruiting
All India Institute of Medical Sciences
Delhi, 110029
Clinical Research Coordinator, +91 941-160-2782
- Recruiting
Lisie Hospital
Kochi, Kerala, 682018
Clinical Research Coordinator, +91 859-095-8869
- Recruiting
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
New Delhi, 110002
Clinical Research Coordinator
+91 6205261118
- Recruiting
Christian Medical College (CMC) Vellore, Ranipet Campus
Vellore, TamiNadu, 632517
Clinical Research Coordinator, +91 987-249-3649
About this study
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
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:
Read more
- 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.
- Conditions
- Acute Pancreatitis
- Being tested
- RABI-767
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RABI-767Drug
125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection.
| Study group | Role | What they receive |
|---|---|---|
| RABI-767 plus Standard-of-Care | Experimental | Single-dose 125 mg RABI-767 plus standard-of-care Receives: Drug: RABI-767 |
| Standard-of-Care Only | No intervention | No Intervention, Standard-of-Care Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)
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.
Measured: Enrollment/Randomization to Day 35 Follow-up
Change from Baseline in Clinical Chemistry Parameters
Measured: Baseline to Day 7
Change from Baseline in Hematology Parameters
Measured: Baseline to Day 7
Change from Baseline in Vital Signs
Measured: Baseline to Day 7
Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements
Measured: Baseline to Day 7
Secondary outcomes (16)
Development of Severe Acute Pancreatitis
Defined as >48 hours persistent organ failure
Measured: Day 1 to Day 28 (or hospital discharge, if earlier)
Development of New Onset Moderately Severe Acute Pancreatitis
Defined as transient organ failure and/or local or systemic complications without persistent organ failure
Measured: Day 1 to Day 28 (or hospital discharge, if earlier)
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.
Measured: Baseline to Day 60 Follow-up
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.
Measured: Baseline to Day 60 Follow-up
Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis
Death caused by acute pancreatitis and/or complications secondary to acute pancreatitis
Measured: Day 1 to Day 60 Follow-up
Mortality due to any cause
Death due to any cause
Measured: Day 1 to Day 60 Follow-up
Days in Hospital
Measured: Day 1 through Day 28 (or hospital discharge, if earlier)
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.
Measured: From initial hospital discharge to Day 35 Follow-up
Length of Stay in Intensive Care Unit
Measured: Day 1 through Day 28 (or hospital discharge, if earlier)
Development of New Onset Infection
May be further sub-grouped by: pancreatic, peripancreatic, and extra-pancreatic infections, as data allow.
Measured: Day 1 to Day 28 (or hospital discharge, if earlier)
Change in Modified Marshall Score
Measured: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Sequential Organ Failure Assessment (SOFA) Score
Measured: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment
Measured: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Abdominal Pain Numeric Rating Score
Measured: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis
Measured: From Baseline through Day 60 Follow-up
Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis
Measured: From Baseline through Day 60 Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start28 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panafina, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080789
- Sponsor's protocol ID
- RABI-767-201
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06080789
- Acronym / sponsor ID
- RABI-767-201
- Conditions
- Acute Pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Panafina, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RABI-767 plus Standard-of-Care | Experimental | Drug: RABI-767Single-dose 125 mg RABI-767 plus standard-of-care |
| Standard-of-Care Only | No intervention | –No Intervention, Standard-of-Care Only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RABI-767125 mg single-dose given by endoscopic-ultrasound (EUS) guided peripancreatic injection. | Drug | RABI-767 plus Standard-of-Care |
Primary outcome
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.
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.
Change from Baseline in Clinical Chemistry Parameters
Time frame: Baseline to Day 7
Change from Baseline in Hematology Parameters
Time frame: Baseline to Day 7
Change from Baseline in Vital Signs
Time frame: Baseline to Day 7
Change from Baseline in Pulse Oximetry and Oxygen Delivery Measurements
Time frame: Baseline to Day 7
16 secondary outcomes
Development of Severe Acute Pancreatitis
Time frame: Day 1 to Day 28 (or hospital discharge, if earlier)
Development of New Onset Moderately Severe Acute Pancreatitis
Time frame: Day 1 to Day 28 (or hospital discharge, if earlier)
Development of Pancreatic Necrosis
Time frame: Baseline to Day 60 Follow-up
Development of Local Complications of Acute Pancreatitis
Time frame: Baseline to Day 60 Follow-up
Mortality due to acute pancreatitis and/or complications secondary to acute pancreatitis
Time frame: Day 1 to Day 60 Follow-up
Mortality due to any cause
Time frame: Day 1 to Day 60 Follow-up
Days in Hospital
Time frame: Day 1 through Day 28 (or hospital discharge, if earlier)
Re-hospitalization for acute pancreatitis or related complications
Time frame: From initial hospital discharge to Day 35 Follow-up
Length of Stay in Intensive Care Unit
Time frame: Day 1 through Day 28 (or hospital discharge, if earlier)
Development of New Onset Infection
Time frame: Day 1 to Day 28 (or hospital discharge, if earlier)
Change in Modified Marshall Score
Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Sequential Organ Failure Assessment (SOFA) Score
Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Systemic Inflammatory Response Syndrome (SIRS) Assessment
Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Abdominal Pain Numeric Rating Score
Time frame: From Baseline through Day 28 (or hospital discharge, if earlier)
Change in Computed Tomography Severity Index (CTSI) Score for Pancreatitis
Time frame: From Baseline through Day 60 Follow-up
Change in Modified Computed Tomography Severity Index (mCTSI) Score for Pancreatitis
Time frame: From Baseline through Day 60 Follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RABI-767 in people with Acute Pancreatitis, run by Panafina, Inc. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Abernathy (9194609500, kabernathy@arrivobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Enrollment/Randomization to Day 28 (or hospital discharge, if earlier)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.