CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS

NCT03401190 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CM4620-201
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 9

Brief Summary

This open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases. The first phase will consist of 4 female and 4 male patients (cohorts 1 and 2, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for first phase will be CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4. The second phase will consist of 8 female and 8 male patients (cohorts 3 and 4, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for second phase will be CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4. Dose escalation to second phase would only occur if needed for efficacy reasons and if no events suggesting a safety signal would occur with higher dosing. The study is not powered for the analysis of study data with inferential statisitcs as the primary purpose of the study is to explore what endpoints would be most appropriate for future trials.

Conditions

Acute Pancreatitis; Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (1)

• The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia.

  Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period.

  90 Days

Secondary Outcomes (6)

• The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier)

  5 days (or discharge, if earlier)

• The Number of Patients Tolerating Solid Food

  at 72 hours (or discharge, if earlier)

• The Number of Patients Tolerating Solid Food

  at Day 10 (or discharge, if earlier)

• Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS)

  ≥ 48 hours

• IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours

  Day 10 (or discharge, if earlier)

Study Arms (3)

Low Dose Group

EXPERIMENTAL

Phase 1: Cohorts 1 \& 2 will consist of 4 female and 4 male patients enrolled concurrently who will be randomized 3:1 to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4.

Drug: CM4620 Injectable Emulsion (Low Dose)

High Dose Group

EXPERIMENTAL

Phase 2: Cohorts 3 \& 4 will consist of 8 female and 8 male patients enrolled concurrently who will be randomized 3:1 to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 2.08 mg/kg of CM4620-IE on Days 1 and 2, and 1.6 mg/kg on Days 3 and 4.

Drug: CM4620 Injectable Emulsion (High Dose)

Standard of Care

NO INTERVENTION

For all cohorts, patients will be randomized 3:1 to CM4620-IE plus standard of care versus standard of care alone.

Interventions

CM4620 Injectable Emulsion (High Dose) DRUG

CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4, during the second phase of the study (Cohorts 3 and 4). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.

Also known as: CM4620-IE (High Dose)

High Dose Group

CM4620 Injectable Emulsion (Low Dose) DRUG

CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2-4, during the first phase of the study (Cohorts 1 and 2). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.

Also known as: CM4620-IE (Low Dose)

Low Dose Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis and 1 of the following 2 criteria:
• Serum lipase and/or serum amylase \> 3 times the upper limit of normal (ULN);
• Characteristic findings of acute pancreatitis on abdominal imaging;
• A SpO2 \<96% with a FiO2 of 21% (room air) to 27%, or a SpO2 \<97% with a FiO2 ≥28%;
• Diagnosis of SIRS, defined by the presence of at least 2 of the following 4 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;
• No evidence of pancreatic necrosis on contrast-enhanced computed tomography (CECT performed in the 18 hours prior to consent or after consent and before Day 1;
• Adults ≥ 18 years of age;
• A female patient of child bearing potential who is sexually active with a male partner must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE;
• A male patient who is sexually active with a female partner of childbearing potential must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE and must not donate sperm for 365 days.
• Willing and able to, or have a legal authorized representative (LAR) that is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

You may not qualify if:

• Any concurrent clinical condition that a study physician believes could potentially pose an unacceptable health risk to the patient while involved in the study, including a CV SOFA score of 4 at the time of screening, or may limit expected survival to \<6 months;
• Suspected presence of cholangitis in the judgment of the treating investigator;
• ERCP performed in the previous 7 days;
• Any malignancy being treated with chemotherapy or immunotherapy;
• Any autoimmune disease being treated with immunosuppressive medication or immunotherapy;
• History of:
• Acute pancreatitis with pancreatic necrosis on Contrast-Enhanced Computed Tomography (CECT) of the pancreas;
• Chronic pancreatitis, pancreatic necrosis or necrosectomy, or pancreatic enzyme replacement therapy;
• Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy;
• Known hepatitis B or C, or HIV;
• History of organ or hematologic transplant;
• Resuscitated cardiac arrest, myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1;
• Current renal replacement therapy;
• Current known abuse of cocaine or methamphetamine;
• Known to be pregnant or are nursing;

Sponsors & Collaborators

• CalciMedica, Inc.: lead

Study Sites (9)

Detroit Receiving Hospital (Wayne State)

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Sinai-Grace Hospital (Wayne State)

Detroit, Michigan, 48235, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

MetroHealth (Case Western)

Cleveland, Ohio, 44109, United States

Location

Riverside Methodist

Columbus, Ohio, 43214, United States

Location

Ben Taub (Baylor College of Medicine)

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Bruen C, Miller J, Wilburn J, Mackey C, Bollen TL, Stauderman K, Hebbar S. Auxora for the Treatment of Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome: Clinical Development of a Calcium Release-Activated Calcium Channel Inhibitor. Pancreas. 2021 Apr 1;50(4):537-543. doi: 10.1097/MPA.0000000000001793.

  PMID: 33939666 DERIVED

Related Links

• Auxora for the treatment of patients with Acute Pancreatitis and accompanying SIRS: Phase 2a study results

MeSH Terms

Conditions

Pancreatitis; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sudarshan Hebbar, MD
• Organization: CalciMedica, Inc.

sudarshan@calcimedica.com

816-838-7105

Study Officials

• Sudarshan Hebbar, MD

  Chief Medical Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 17, 2018
• Study Start: March 12, 2018
• Primary Completion: February 14, 2019
• Study Completion: April 30, 2019
• Last Updated: March 30, 2026
• Results First Posted: December 7, 2021

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)