Acute PancreatitisPhase 2NCT03401190
CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
A Phase 2 study testing CM4620 Injectable Emulsion (Low Dose) and CM4620 Injectable Emulsion (High Dose) in people with Acute Pancreatitis and Systemic Inflammatory Response Syndrome, run by CalciMedica, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Systemic Inflammatory Response Syndrome
- What is being tested?
- CM4620 Injectable Emulsion (Low Dose) and CM4620 Injectable Emulsion (High Dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Mar 2018to 30 Apr 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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.
Who cannot join
- 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:
Show all 17Show fewer
- 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;
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
MetroHealth (Case Western)
Cleveland, Ohio, 44109
Riverside Methodist
Columbus, Ohio, 43214
Detroit Receiving Hospital (Wayne State)
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Sinai-Grace Hospital (Wayne State)
Detroit, Michigan, 48235
Ben Taub (Baylor College of Medicine)
Houston, Texas, 77030
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Regions Hospital
Saint Paul, Minnesota, 55101
Washington University
St Louis, Missouri, 63110
About this study
Official title: An Open-Label, Dose-Response Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS)
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.
- Being tested
- CM4620 Injectable Emulsion (Low Dose), CM4620 Injectable Emulsion (High Dose)
- Medical subject headings
- Pancreatitis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM4620 Injectable Emulsion (Low Dose)Drug
Also called CM4620-IE (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.
CM4620 Injectable Emulsion (High Dose)Drug
Also called CM4620-IE (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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 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
Measured: 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
Measured: 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.
Measured: ≥ 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.
Measured: Day 10 (or discharge, if earlier)
Median Days in Hospital
Length of stay in hospital in days (randomization to discharge)
Measured: discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start12 Mar 2018
- Primary completion14 Feb 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CalciMedica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudarshan Hebbar, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401190
- Sponsor's protocol ID
- CM4620-201
- Status last verified
- Mar 2026
- First submitted
- 26 Dec 2017
- Last updated
- 30 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Response Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS)
- ClinicalTrials.gov ID
- NCT03401190
- Acronym / sponsor ID
- CM4620-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CalciMedica, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 7 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Group | Experimental | Drug: CM4620 Injectable Emulsion (Low Dose)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. |
| High Dose Group | Experimental | Drug: CM4620 Injectable Emulsion (High Dose)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis and 1 of the following 2 criteria:
- 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:
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM4620 Injectable Emulsion (Low Dose)Also: CM4620-IE (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. | Drug | Low Dose Group |
| CM4620 Injectable Emulsion (High Dose)Also: CM4620-IE (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. | Drug | High Dose Group |
Primary outcome
The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia.
Time frame: 90 Days
Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period.
6 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)
Time frame: 5 days (or discharge, if earlier)
The Number of Patients Tolerating Solid Food
Time frame: at 72 hours (or discharge, if earlier)
The Number of Patients Tolerating Solid Food
Time frame: at Day 10 (or discharge, if earlier)
Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS)
Time frame: ≥ 48 hours
IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours
Time frame: Day 10 (or discharge, if earlier)
Median Days in Hospital
Time frame: discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33939666Bruen 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.
- Auxora for the treatment of patients with Acute Pancreatitis and accompanying SIRS: Phase 2a study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudarshan Hebbar, MD study director
Chief Medical Officer
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM4620 Injectable Emulsion (Low Dose) and CM4620 Injectable Emulsion (High Dose) in people with Acute Pancreatitis and Systemic Inflammatory Response Syndrome, run by CalciMedica, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03401190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.