A Phase 2 interventional study of CM4620-IE in Acute Pancreatitis, sponsored by CalciMedica, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by CalciMedica, Inc. · Phase 2, Interventional, and Treatment
This open-label study will evaluate the pharmacodynamic and pharmacokinetic profile of CM4620-IE in patients with acute pancreatitis. The first five (5) patients will receive ≤ 2.08 mg/kg of CM4620-IE by continuous IV infusion on Day 1. If necessary, up to an additional 4 patients may be treated at a different dose of CM4620-IE as determined by the obtained PK and PD data. The infusion of CM4620-IE will start within 12 hours from the time the patient or LAR provides informed consent.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's enrollment of 7 is below the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →CalciMedica, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis, and 1 of the following 2 criteria:
Exclusion Criteria:
History of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: CM4620-IE
single IV infusion on Day 1 over 4 hours
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values
Outcome assessed the percent change in IL-2 production after the administration of a single dose of CM4620-IE as compared to baseline production, for all patients enrolled. This measurement was to explore if there was a change in IL-2 levels with acute pancreatitis after the administration of a single dose of CM4620-IE.
Time frame: Predose to 30 minutes post dose
The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number of participants who experienced treatment-emergent adverse events (TEAEs) with Investigator-specified relationship to CM4620-IE and assessment of severity.
Time frame: From baseline through 30 days
Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion
Time frame: Days 1, 2, 5, 10 and 30 or at discharge if earlier than day 30
Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion
Time points for sampling of plasma for bioanalysis of CM4620, blood for PD analysis (stimulated IL-2 release), and serum for cytokine analysis were chosen to capture the expected maximal plasma concentration (Cmax) on Day 1 and times close to the minimum plasma concentration (Cmin) on subsequent days.
Time frame: Day 2
Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge
Time frame: Day 10, or day of discharge
Pharmacokinetics (Plasma Concentration of CM4620): Day 30
Time frame: Day 30
Baseline Levels of IL-6
Included plasma samples collected 1 hour prior to the study drug administration
Time frame: Baseline
Day 1: 30 Minutes Post-infusion IL-6 Levels
Time frame: Day 1
Day 2: 20-hr Post Infusion IL-6 Levels
Time frame: Day 2
Post-infusion IL-6 Levels at Discharge
This sample was drawn immediately prior to discharge from hospitalization, and ranged from day 2 through day 9.
Time frame: Assessed at Discharge, between 2 and 9 days.
| Milestone | All Patients |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
Outcome assessed the percent change in IL-2 production after the administration of a single dose of CM4620-IE as compared to baseline production, for all patients enrolled. This measurement was to explore if there was a change in IL-2 levels with acute pancreatitis after the administration of a single dose of CM4620-IE.
| percentage of change in IL-2 production | All Patients |
|---|---|
| Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values | -55.5 ± 5.8 |
The number of participants who experienced treatment-emergent adverse events (TEAEs) with Investigator-specified relationship to CM4620-IE and assessment of severity.
| Participants | All Patients |
|---|---|
| The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 3 |
| Nanograms/mL | All Patients |
|---|---|
| Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion | 791 ± 47 |
Time points for sampling of plasma for bioanalysis of CM4620, blood for PD analysis (stimulated IL-2 release), and serum for cytokine analysis were chosen to capture the expected maximal plasma concentration (Cmax) on Day 1 and times close to the minimum plasma concentration (Cmin) on subsequent days.
| Ng/mL | All Patients |
|---|---|
| Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion | 109 ± 49 |
| Ng/mL | All Patients |
|---|---|
| Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge | 76 ± 46 |
| Ng/mL | All Patients |
|---|---|
| Pharmacokinetics (Plasma Concentration of CM4620): Day 30 | 56 ± 32 |
Included plasma samples collected 1 hour prior to the study drug administration
| pg/mL | All Patients |
|---|---|
| Baseline Levels of IL-6 | 46.04 ± 26.3 |
| pg/mL | All Patients |
|---|---|
| Day 1: 30 Minutes Post-infusion IL-6 Levels | 40.83 ± 23.29 |
| pg/mL | All Patients |
|---|---|
| Day 2: 20-hr Post Infusion IL-6 Levels | 24.8 ± 12.4 |
This sample was drawn immediately prior to discharge from hospitalization, and ranged from day 2 through day 9.
| pg/mL | All Patients |
|---|---|
| Post-infusion IL-6 Levels at Discharge | 13.9 ± 2.0 |
Collected over Adverse event data were collected over 90 days per subject, from the start of dosing until the 30-day follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients | 0/7 (0%) | 1/7 (14.3%) | 3/7 (42.9%) |
| Event | All Patients |
|---|---|
| Acute PancreatitisGastrointestinal disorders | 1/7 |
| Respiratory DistressRespiratory, thoracic and mediastinal disorders | 1/7 |
| Event | All Patients |
|---|---|
| MelaenaGastrointestinal disorders | 1/7 |
| BursitisSkin and subcutaneous tissue disorders | 1/7 |
| Acute PancreatitisGastrointestinal disorders | 1/7 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/7 |
| Alcohol Withdrawal SyndromeGeneral disorders | 1/7 |
| PyrexiaGeneral disorders | 1/7 |
| Respiratory DistressRespiratory, thoracic and mediastinal disorders | 1/7 |
| Age, Continuous(years) | All Patients |
|---|---|
| Mean | 42 ± 8.7 |
| Sex: Female, Male(Participants) | All Patients |
|---|---|
| Female | 2 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | All Patients |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Patients |
|---|---|
| United States | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2019 to primary completion in Mar 2019, 2 months.
Results were first posted in May 2022, 3 years 1 month after primary completion.
Of 22 phase 2 interventional studies under Pancreatitis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 110. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zegocractin
CalciMedica, Inc.