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
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
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Clinical Trial Information
Trial Contact: Garcia de Djuro, Ginette; Shepherd, Adriane R
Trial Phone: 321.841.6649 ; 321 841-2285
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IRB No: S23.200.09
Protocol Abbrev: RABI-767-201
Principal Investigator: C. Mel Wilcox, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: RABI-767-201
Treatment: Study Drug: RABI-767
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT06080789
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Objective
To evaluate the safety of a single dose of RABI-767 administered by EUS-guided
peripancreatic injection plus standard-of-care versus standard-of-care only in adult
participants with predicted severe acute pancreatitis -
Key Eligibility
1. Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with
acute pancreatitis and at least one of the following two criteria:
a. Serum lipase and/or serum amylase >3x the upper limit of normal (ULN)
b. Characteristic findings of acute pancreatitis on abdominal imaging
2. Predicted severe acute pancreatitis, based on meeting at least one of the below criteria
(either a, b, or c below) at any time prior to randomization:
a. C-reactive protein >150 mg/L; or
b. ALL 4 criteria met for Systemic Inflammatory Response Syndrome (SIRS), as listed
below:
• Temperature < 36°C or > 38°C;
• Heart rate > 90 beats per minute;
• Respiratory rate > 20 breaths per minute, or PaCO2 < 32 mmHg;
• White blood cell (WBC) count > 12,000 mm3, or < 4,000 mm3, or
> 10% immature (band) forms; or
c. BISAP score ≥3
• BUN >25 mg/dL (1 point)
• Abnormal mental status; Glasgow coma score <15 (1 point)
• Evidence of SIRS (2 or more SIRS criteria met) (1 point)
• Age > 60 years old (1 point)
• Imaging study reveals pleural effusion (1 point)
3. Lack of clinically meaningful improvement from the status at admission, at the discretion of
the Investigator, at the time of randomization.
NOTE: Lack of clinically meaningful improvement from the status at admission
should be re-verified at Pre-dose for participants randomized to RABI-767+SoC or at
Day 1 AM for participants randomized to SoC Only.
4. Participant is suitable for EUS-guided drug administration procedure, including the use of
anesthesia/sedation, in the opinion of the Investigator, and from a logistics/scheduling
perspective, the EUS-guided dosing procedure can be performed within 24 hours of
randomization.
5. Contrast-enhanced computed tomography (CECT) of the abdomen/pancreas performed within
48 hours prior to randomization is available for the evaluation of exclusion criteria. Note: If
Sponsor: Panafina, Inc. Protocol No: RABI-767-201
Confidential Version: 2.0 - Amendment 1
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available, contrast-enhanced magnetic resonance imaging (CEMRI) of the pancreas performed
within 48 hours prior to randomization may be used in place of CECT.
6. Adults 18-85 years of age.
7. Agree to comply with study contraception requirements, as follows:
• Female participants of child-bearing potential who are sexually active with male partners
and male participants who are sexually active with female partners of child-bearing
potential must agree to use a highly effective method of contraception for a period of at
least 30 days after study drug administration.
• Surgically sterile females and males and postmenopausal females (ie, with > 2 years of
amenorrhea) are not required to use contraception.
8. Willing and able to understand and provide written informed consent to participate in the
study, and to cooperate with all aspects of the protocol.
NOTE: Prospective participants with altered mental status or who are only able to
consent by proxy through a legally authorized representative should be excluded from
