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

NCT04681066 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CM4620-203
• Study Type: interventional
• Target: 216
• Locations: 2 countries
• Sites: 37

Brief Summary

Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. 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. It is recommended that patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection necessitating continued hospitalization.

Conditions

Acute Pancreatitis; Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (1)

• Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship

  Time to Solid Food Tolerance (TSFT): Number of hours from date/time of SFISD to date/time patient receives a solid meal that is tolerated, defined as eating \>/=50% of a low fat \>/= 500-calorie solid meal w/o increase in abdominal pain or vomiting within 2 hours of mealtime. If patient was discharged w/o tolerating solid food, the daily record of the modified ANMS Gastrointestinal Cardinal Symptom Index Daily Diary (mGCSI-DD) at or after hospital discharge was used to calculate TSFT. For these patients, TSFT date/time was considered to be 8am on the first of 3 consecutive days where the following criteria were met in mGCSI-DD: no vomiting, no or mild nausea, no or mild inability to finish a normal sized meal, no or mild abdominal pain. gMCP-Mod: Generalized Multiple Comparisons and Modeling--3 steps: 1) Hazard ratio (dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low). 2) Multiple contrast test. 3) Find best-fit dose-response model.

  from start of first infusion of study drug (SFISD) through day 30

Secondary Outcomes (11)

• Percentage of Patients With New Onset Severe Respiratory Failure, With gMCP Modeling Analysis for Dose-response Relationship

  from enrollment and through day 30

• Incidence, Severity, and Duration of Organ Failure

  from enrollment and through day 30

• Solid Food Tolerance

  from SFISD to 48 hours, 72 hours and 96 hours and at time of hospital discharge (up to 30 days after SFISD)

• Time to Medically Indicated Discharge

  from start of first infusion of study drug through time of hospital discharge or through Day 30, whichever occurs first

• Length of Stay in the Hospital

  from admission date into the hospital until discharge date from the hospital

Other Outcomes (6)

• Win Ratio for Auxora vs. Placebo

  from randomization through Day 30

• Development of Infected Pancreatic Necrosis

  from end of first infusion of study drug through Day 30 CECT

• Development of Sepsis

  from end of first infusion of study drug through day 30

Study Arms (4)

2.0 mg/kg (1.25 mL/kg)

ACTIVE COMPARATOR

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.

Drug: CM-4620 Injectable Emulsion or CM-4620-IE

1.0 mg/kg (0.625 mL/kg)

ACTIVE COMPARATOR

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.

Drug: CM-4620 Injectable Emulsion or CM-4620-IE

0.5 mg/kg (0.3125 mL/kg)

ACTIVE COMPARATOR

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.

Drug: CM-4620 Injectable Emulsion or CM-4620-IE

Placebo (1.25, 0.625, or 0.3125 mL/kg)

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

CM-4620 Injectable Emulsion or CM-4620-IE DRUG

Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection.

Also known as: Auxora

0.5 mg/kg (0.3125 mL/kg); 1.0 mg/kg (0.625 mL/kg); 2.0 mg/kg (1.25 mL/kg)

Placebo OTHER

Matching Placebo is to be administered as an IV infusion and is supplied as a translucent, white to yellowish, sterile, non-pyrogenic emulsion carrier containing no active pharmaceutical ingredient. Placebo is supplied as an 80 mL fill in a 100 mL single-use vial. Placebo contains the same ingredients as Auxora except that it does not contain CM4620.

Placebo (1.25, 0.625, or 0.3125 mL/kg)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self-reported gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the following must be met for a patient to be randomized into the study:
• 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:
• Serum lipase \> 3 times the upper limit of normal (ULN);
• Characteristic findings of acute pancreatitis on abdominal imaging;
• The diagnosis of SIRS has been established by the presence of at least two of the following four criteria:
• Temperature \< 36°C or \> 38°C;
• Heart rate \> 90 beats/minute;
• Respiratory rate \>20 breaths/minute or arterial carbon dioxide tension (PaCO2) \<32 mmHg;
• White blood cell count (WBC) \>12,000 mm3, or \<4,000 mm3, or \> 10% immature (band) forms;
• At least one of the following criteria is also present:
• A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 24 hours before Consent or after Consent and before Randomization;
• Abdominal examination documenting either abdominal guarding or rebound tenderness;
• Hematocrit ≥44% for men or ≥40% for women;
• The patient is ≥ 18 years of age;
• Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 24 hours before Consent or after Consent and before Randomization;

You may not qualify if:

• Patients with any of the following conditions or characteristics must be excluded from randomizing:
• Expected survival \<6 months;
• Suspected presence of cholangitis in the judgment of the treating physician;
• The patient has a known history of:
• Organ or hematologic transplant;
• HIV, hepatitis B, or hepatitis C infection;
• Chronic pancreatitis;
• Current treatment with:
• Chemotherapy;
• Immunosuppressive medications or immunotherapy
• Pancreatic enzyme replacement therapy;
• Hemodialysis or Peritoneal Dialysis;
• The patient is known to be pregnant or is nursing;
• The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization;
• Allergy to eggs or known hypersensitivity to any components of study drug.

Sponsors & Collaborators

• CalciMedica, Inc.: lead

Study Sites (37)

Long Beach Medical Center

Long Beach, California, 90806, United States

Location

LA County Hospital - USC

Los Angeles, California, 90033, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

University of California at Irvine Medical Center

Orange, California, 92868, United States

Location

Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

The Stamford Hospital

Stamford, Connecticut, 06902, United States

Location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Northwestern University Hospital

Chicago, Illinois, 60611, United States

Location

Robley Rex VA Medical Center

Louisville, Kentucky, 40206, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Methodist Hospital

Saint Louis Park, Minnesota, 55426, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

University of Missouri School of Medicine

Columbia, Missouri, 65212, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Northshore University Hospital

Manhasset, New York, 11030, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Ohio State University

Columbus, Ohio, 43201, United States

Location

Regional One Health

Memphis, Tennessee, 38106, United States

Location

John Peter Smith Hospital

Fort Worth, Texas, 76104, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

UT Health Houston

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

CAMC Institute for Academic Medicine

Charleston, West Virginia, 25304, United States

Location

SPMC

Bīkaner, India

Location

PGIMER, Chandigarh

Chandigarh, India

Location

Malla Reddy Narayana

Hyderabad, India

Location

MDM Hospital

Jodhpur, India

Location

Lisie Hospital

Kochi, India

Location

Seven Star Hospital

Nagpur, India

Location

JIPMER

Puducherry, India

Location

MTES' Sanjeevan Hospital

Pune, India

Location

Shree Giriraj Multispeciality Hospital

Rajkot, India

Location

IGMU (India Gandhi Medical)

Shimla, India

Location

MeSH Terms

Conditions

Pancreatitis; Systemic Inflammatory Response Syndrome

Interventions

zegocractin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: Sudarshan Hebbar (Chief Medical Officer)
• Organization: CalciMedica

sudarshan@calcimedica.com

(816) 838-7105

Study Officials

• Sudarshan Hebbar, MD

  CalciMedica, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Matching placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 23, 2020
• Study Start: March 24, 2021
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (10); US (27)