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Anti-inflammatory agent

Auxora for Acute Pancreatitis (CARPO Trial)

Phase 2

Recruiting

Research Sponsored by CalciMedica, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:

The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment through day 30

Awards & highlights

CARPO Trial Summary

This trial will study the effects of Auxora, a new potential treatment for acute pancreatitis, in 216 patients. Patients will be randomly assigned to one of three dose levels of Auxora or one of three placebo volumes. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment.

Who is the study for?

This trial is for adults with acute pancreatitis and SIRS, confirmed by specific lab tests, imaging, and symptoms. Participants must not have chronic pancreatitis or a history of certain pancreatic conditions. They should be free from severe infections like HIV/hepatitis, not on dialysis or recent other trials, and willing to use birth control if applicable.Check my eligibility

What is being tested?

The study compares Auxora at different doses against a placebo in patients with acute pancreatitis accompanied by SIRS. It's double-blind (neither doctors nor patients know who gets what), involving three daily infusions over three days while hospitalized.See study design

What are the potential side effects?

While the side effects are not explicitly listed here, common risks may include allergic reactions to the drug components (e.g., egg allergies), potential infection risk due to weakened immune responses from treatment, and general discomfort from infusion.

CARPO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with acute pancreatitis.

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I or my legal representative can consent to and follow the study requirements.

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I am 18 years old or older.

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I agree to use birth control for 6 months after my last dose.

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My pancreas has no necrosis, calcifications, pseudocysts, or previous surgeries.

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I am a man who will use birth control for 6 months after the last drug dose and won't donate sperm.

CARPO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from sfisd to 48 hours, 72 hours and 96 hours and at time of hospital discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from sfisd to 48 hours, 72 hours and 96 hours and at time of hospital discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and from sfisd to 48 hours, 72 hours and 96 hours and at time of hospital discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to solid food tolerance

Secondary outcome measures

Change in opioid use

Pain

Change in severity of acute pancreatitis by CTSI score from screening to Day 30

+9 more

Other outcome measures

Change in ANC/ALC ratio and IL-6 levels

Change in GCSI-DD score

Change in albumin

+4 more

CARPO Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: 0.5 mg/kg (0.3125 mL/kg)Active Control1 Intervention

administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

Group II: 2.0 mg/kg (1.25 mL/kg)Active Control1 Intervention

administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

Group III: 1.0 mg/kg (0.625 mL/kg)Active Control1 Intervention

administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

Group IV: Placebo (1.25, 0.625, or 0.3125 mL/kg)Placebo Group1 Intervention

patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

CalciMedica, Inc.Lead Sponsor

6 Previous Clinical Trials

363 Total Patients Enrolled

3 Trials studying Acute Pancreatitis

70 Patients Enrolled for Acute Pancreatitis

Sudarshan Hebbar, MDStudy DirectorCalciMedica, Inc.

4 Previous Clinical Trials

312 Total Patients Enrolled

2 Trials studying Acute Pancreatitis

28 Patients Enrolled for Acute Pancreatitis

Media Library

CM-4620 Injectable Emulsion or CM-4620-IE (Anti-inflammatory agent) Clinical Trial Eligibility Overview. Trial Name: NCT04681066 — Phase 2

Acute Pancreatitis Research Study Groups: Placebo (1.25, 0.625, or 0.3125 mL/kg), 0.5 mg/kg (0.3125 mL/kg), 2.0 mg/kg (1.25 mL/kg), 1.0 mg/kg (0.625 mL/kg)

Acute Pancreatitis Clinical Trial 2023: CM-4620 Injectable Emulsion or CM-4620-IE Highlights & Side Effects. Trial Name: NCT04681066 — Phase 2

CM-4620 Injectable Emulsion or CM-4620-IE (Anti-inflammatory agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04681066 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for individuals who would like to participate in this research?

"Affirmative. The clinicaltrials.gov page for this trial verifies that recruitment is open, with the initial post date being March 24th 2021 and the last update taking place on November 30th 2022. 216 individuals are necessary to be recruited from a total of 30 sites."

Answered by AI

How many volunteers have registered for this trial as of now?

"The sponsor, CalciMedica Inc., requires a sum of 216 participants that meet the trial's eligibility criteria for this study to be conducted. These patients will be recruited from Regional One Health in Memphis and UCLA Ronald Reagan Medical Centre in Los Angeles."

Answered by AI

In how many venues is this clinical research being administered?

"Currently, there are 30 medical centres participating in this trial. Major cities such as Memphis, Los Angeles and Houston have sites available, with other locations spread accross the country. To minimize strain on patients enrolled in the study, it is recommended to choose a site near your residence."

Answered by AI

To what degree is 1.0 mg/kg (0.625 mL/kg) hazardous to patients?

"Our team at Power rated the safety of 1.0 mg/kg (0.625 mL/kg) with a score of 2 due to the preliminary evidence backing its security, as it is currently being tested in Phase 2 trials without any efficacy data yet collected."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS

2021. "A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04681066.

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