CompletedNCT03401190Updated Mar 30, 2026Results posted

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

A Phase 2 interventional study of CM4620 Injectable Emulsion (Low Dose) and CM4620 Injectable Emulsion (High Dose) in Acute Pancreatitis and Systemic Inflammatory Response Syndrome, sponsored by CalciMedica, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by CalciMedica, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 21
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

After review of the efficacy, tolerability and safety data from cohorts 1 and 2 by the sponsor and the United States Food and Drug Administration, the decision was made to continue the low-dose regimen (CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4) in cohort 3. Cohort 4 received the high-dose regimen (CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4) as planned. Efficacy analysis were combined because no dose escalation occurred in cohort 3.

Patients were followed for 90 days after randomization.

Conditions studied

Acute Pancreatitis
Systemic Inflammatory Response Syndrome

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis and 1 of the following 2 criteria:
1. Serum lipase and/or serum amylase > 3 times the upper limit of normal (ULN);
2. 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:
1. Temperature \< 36°C or > 38°C;
2. Heart rate > 90 beats/minute;
3. Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) \<32 mmHg;
4. 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.

Exclusion criteria

Exclusion Criteria:

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:
1. Acute pancreatitis with pancreatic necrosis on Contrast-Enhanced Computed Tomography (CECT) of the pancreas;
2. Chronic pancreatitis, pancreatic necrosis or necrosectomy, or pancreatic enzyme replacement therapy;
3. Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy;
4. Known hepatitis B or C, or HIV;
5. History of organ or hematologic transplant;
6. 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;
Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1;
History of allergy to eggs or known hypersensitivity to any components of CM4620-IE.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 21 participants (actual)

Study arms

Experimental
Low Dose Group
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)
Experimental
High Dose Group
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)
No intervention
Standard of Care
For all cohorts, patients will be randomized 3:1 to CM4620-IE plus standard of care versus standard of care alone.

Interventions

DrugCM4620 Injectable Emulsion (Low Dose)
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)
DrugCM4620 Injectable Emulsion (High Dose)
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)

What researchers measure

Primary outcomes

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.
Time frame: 90 Days

Secondary outcomes

The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier)
CTSI score measures abnormal pancreatic morphology and is the sum of two subscales. The Balthazar subscale rates pancreatic CT image findings on a scale of 0 (normal) to 4 (2 or more peri-pancreatic fluid collections. The Pancreatic Necrosis subscale rates pancreatic necrosis from 0 (none) to 6 (\>50%). The two subscales are summed for a CTSI score of 0-3 (mild AP), 4-6 (moderate AP), and 7-10 (severe AP).
Time frame: 5 days (or discharge, if earlier)
The Number of Patients Tolerating Solid Food
Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain
Time frame: at 72 hours (or discharge, if earlier)
The Number of Patients Tolerating Solid Food
Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain
Time frame: at Day 10 (or discharge, if earlier)
Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS)
The presence of SIRS was defined as 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 cells/mm3 or \< 4,000 cells/mm3 or \> 10% immature (band) forms. * The SIRS score was determined at Screening, prior to randomization, and every 12 hours until Day 6, after which it was determined every 24 hours.
Time frame: ≥ 48 hours
IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours
Assess blood serum samples to be analyzed for interleuken (IL-6) llevels pg/mL collected in the first 24 hours and daily thereafter. Samples were sent to the central laboratory. The results were not provided to the Principal Investigator or treating physician.
Time frame: Day 10 (or discharge, if earlier)
Median Days in Hospital
Length of stay in hospital in days (randomization to discharge)
Time frame: discharge

Results

Posted Dec 7, 2021

Participant flow

Participant flow — Overall Study
Milestone	Low Dose Group	High Dose Group	Standard of Care Group
Started	8	6	7
Completed	8	4	7
Not completed	0	2	0

Outcome measures

PrimaryThe 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.

Time frame:: 90 Days
Reported as:: Count of participants · Participants

The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia.
Participants	Low Dose Group + SC	High Dose Group + SC	Standard of Care Group (SC)
TEAE patients	7	5	3
Severe TEAE patients	0	2	2
SAE patients	2	1	2
TEAEs leading to discontinuation	0	2	0
TEAEs leading to death	0	1	0
Treatment-related TEAEs	0	1	0

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

CTSI score measures abnormal pancreatic morphology and is the sum of two subscales. The Balthazar subscale rates pancreatic CT image findings on a scale of 0 (normal) to 4 (2 or more peri-pancreatic fluid collections. The Pancreatic Necrosis subscale rates pancreatic necrosis from 0 (none) to 6 (\>50%). The two subscales are summed for a CTSI score of 0-3 (mild AP), 4-6 (moderate AP), and 7-10 (severe AP).

Time frame:: 5 days (or discharge, if earlier)
Reported as:: Count of participants · Participants

The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier)
Participants	Low Dose Group + SC	High Dose Group + SC	Standard of Care Group (SC)
Screening — Number of Patients with Mild AP	4	1	2
Screening — Number of Patients with Moderate AP	4	4	3
Screening — Number of Patients with Severe AP	0	0	1
Day 5 or Discharge, if earlier — Number of Patients with Mild AP	7	1	3
Day 5 or Discharge, if earlier — Number of Patients with Moderate AP	1	4	3
Day 5 or Discharge, if earlier — Number of Patients with Severe AP	0	0	1

SecondaryThe Number of Patients Tolerating Solid Food

Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain

Time frame:: at 72 hours (or discharge, if earlier)
Reported as:: Number · number of patients tolerating solid food

The Number of Patients Tolerating Solid Food
number of patients tolerating solid food	Low Dose Group + SC	High Dose Group + SC	Standard of Care (SC)
The Number of Patients Tolerating Solid Food	5	2	1

SecondaryThe Number of Patients Tolerating Solid Food

Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain

Time frame:: at Day 10 (or discharge, if earlier)
Reported as:: Number · number of patients tolerating solid food

The Number of Patients Tolerating Solid Food
number of patients tolerating solid food	Low Dose Group + SC	High Dose Group + SC	Standard of Care (SC)
The Number of Patients Tolerating Solid Food	8	5	3

SecondaryPercentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS)

The presence of SIRS was defined as 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 cells/mm3 or \< 4,000 cells/mm3 or \> 10% immature (band) forms. * The SIRS score was determined at Screening, prior to randomization, and every 12 hours until Day 6, after which it was determined every 24 hours.

Time frame:: ≥ 48 hours
Reported as:: Count of participants · Participants

Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS)
Participants	Low Dose Group + SC	High Dose Group + SC	Standard of Care (SC)
Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS)	1	4	5

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

Assess blood serum samples to be analyzed for interleuken (IL-6) llevels pg/mL collected in the first 24 hours and daily thereafter. Samples were sent to the central laboratory. The results were not provided to the Principal Investigator or treating physician.

Time frame:: Day 10 (or discharge, if earlier)
Reported as:: Count of participants · Participants

IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours
Participants	Low Dose Group + SC	High Dose Group + SC	Standard of Care Group (SC)
Admission IL-6 Levels — IL-6 ≥ 1000 pg/mL	0	2	0
Admission IL-6 Levels — 150 pg/mL ≤ IL-6 < 1000 pg/mL	4	1	3
Day 10 or discharge IL-6 Levels — IL-6 ≥ 1000 pg/mL	0	0	0
Day 10 or discharge IL-6 Levels — 150 pg/mL ≤ IL-6 < 1000 pg/mL	0	1	2

SecondaryMedian Days in Hospital

Length of stay in hospital in days (randomization to discharge)

Time frame:: discharge
Reported as:: Median · days

Median Days in Hospital
days	Low Dose Group + SC	High Dose Group + SC	Standard of Care Group (SC)
Median Days in Hospital	3.06 (1.5 to 8.2)	6.97 (1.8 to 18.3)	6.02 (1.1 to 30.0)

Adverse events

Collected over Adverse event data were collected over 90 days after randomization.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Low Dose Group	0/8 (0%)	2/8 (25%)	7/8 (87.5%)
High Dose Group	1/6 (16.7%)	1/6 (16.7%)	5/6 (83.3%)
Standard of Care Group	0/7 (0%)	2/7 (28.6%)	3/7 (42.9%)

Most frequent serious events

Most frequent serious events
Event	Low Dose Group	High Dose Group	Standard of Care Group
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/8	1/6	1/7
SepsisInfections and infestations	0/8	1/6	0/7
Acute Respiratory Distress SyndromeRespiratory, thoracic and mediastinal disorders	0/8	1/6	0/7
Hypoxic-Ischemic EncephalopathyNervous system disorders	0/8	1/6	0/7
PneumoniaInfections and infestations	0/8	1/6	1/7
Pulseless Electrical ActivityCardiac disorders	0/8	1/6	0/7
EncephalopathyNervous system disorders	0/8	0/6	1/7
Pneumonia AspirationRespiratory, thoracic and mediastinal disorders	0/8	0/6	1/7
Cystitis Non-infectiveRenal and urinary disorders	1/8	0/6	0/7
Pancreatitis AcuteGastrointestinal disorders	1/8	0/6	0/7

Most frequent other events

Showing 10 of 44

Most frequent other events
Event	Low Dose Group	High Dose Group	Standard of Care Group
MalnutritionMetabolism and nutrition disorders	0/8	2/6	0/7
Confusional statePsychiatric disorders	0/8	2/6	1/7
HypokalemiaMetabolism and nutrition disorders	2/8	1/6	0/7
HeadacheNervous system disorders	2/8	1/6	0/7
Electrolyte imbalanceMetabolism and nutrition disorders	0/8	1/6	0/7
Fluid OverloadMetabolism and nutrition disorders	0/8	1/6	1/7
Fluid retentionMetabolism and nutrition disorders	0/8	1/6	0/7
HyperglycemiaMetabolism and nutrition disorders	0/8	1/6	0/7
HypophosphatemiaMetabolism and nutrition disorders	1/8	1/6	0/7
AnemiaBlood and lymphatic system disorders	0/8	1/6	1/7

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Low Dose Group	High Dose Group	Standard of Care Group	Total
Mean	50.9 ± 14.7	44.3 ± 7.1	54.9 ± 10.7	48.1 ± 12.1

Sex: Female, Male
Sex: Female, Male(Participants)	Low Dose Group	High Dose Group	Standard of Care Group	Total
Female	5	0	4	9
Male	3	6	3	12

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Low Dose Group	High Dose Group	Standard of Care Group	Total
Hispanic or Latino	0	2	0	2
Not Hispanic or Latino	8	4	7	19
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Low Dose Group	High Dose Group	Standard of Care Group	Total
American Indian or Alaska Native	0	0	0	0
Asian	1	0	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	1	2	3	6
White	6	4	4	14
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Low Dose Group	High Dose Group	Standard of Care Group	Total
United States	8	6	7	21

Study locations

9 sites

Detroit Receiving Hospital (Wayne State)
Detroit, Michigan 48201, United States
Henry Ford Hospital
Detroit, Michigan 48202, United States
Sinai-Grace Hospital (Wayne State)
Detroit, Michigan 48235, United States
Hennepin County Medical Center
Minneapolis, Minnesota 55415, United States
Regions Hospital
Saint Paul, Minnesota 55101, United States
Washington University
St Louis, Missouri 63110, United States
MetroHealth (Case Western)
Cleveland, Ohio 44109, United States
Riverside Methodist
Columbus, Ohio 43214, United States
Ben Taub (Baylor College of Medicine)
Houston, Texas 77030, United States

References and documents

Publications

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. PubMed 33939666 ↗

Study documents

Study protocol · Dec 18, 2018
Statistical analysis plan · Mar 3, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03401190
Lead sponsor: CalciMedica, Inc.
Responsible party: Sponsor
First posted: Jan 17, 2018
Start date: Mar 12, 2018
Primary completion: Feb 14, 2019
Completion: Apr 30, 2019
Results posted: Dec 7, 2021
Last update: Mar 30, 2026

Study contacts

Sudarshan Hebbar, MD

study director · Chief Medical Officer

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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