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CompletedNCT03709342Updated May 3, 2022Results posted

A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis

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

Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Pancreatitis

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03

Who can participate

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

Inclusion criteria

  1. 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;
  2. Adults ≥ 18 years of age;
  3. 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;
  4. 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;
  5. Willing and able to, or have a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and cooperate with all aspects of the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Any concurrent clinical condition that a study physician believes could potentially pose an unacceptable health risk to the patient while involved in the study or may limit expected survival to \< 6 months;
  2. Suspected presence of cholangitis in the judgment of the treating investigator;
  3. Any malignancy being treated with chemotherapy or immunotherapy;
  4. Any autoimmune disease being treated with immunosuppressive medication or immunotherapy (Section 5.3 for list of prohibited medications);

  5. History of:

    1. Chronic pancreatitis, pancreatic necrosectomy, or pancreatic enzyme replacement therapy;
    2. Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy;
    3. Known hepatitis B or C, or HIV;
    4. History of organ or hematologic transplant;
    5. Myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1;
  6. Current renal replacement therapy;
  7. Current known abuse of cocaine or methamphetamine;
  8. Known to be pregnant or are nursing;
  9. Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1;
  10. History of allergy to eggs or known hypersensitivity to any components of CM4620-IE;
  11. Prior treatment with CM4620-IE.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    All Patients

    Drug: CM4620-IE

Interventions

  • DrugCM4620-IE

    single IV infusion on Day 1 over 4 hours

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge

    Time frame: Day 10, or day of discharge

  5. Pharmacokinetics (Plasma Concentration of CM4620): Day 30

    Time frame: Day 30

  6. Baseline Levels of IL-6

    Included plasma samples collected 1 hour prior to the study drug administration

    Time frame: Baseline

  7. Day 1: 30 Minutes Post-infusion IL-6 Levels

    Time frame: Day 1

  8. Day 2: 20-hr Post Infusion IL-6 Levels

    Time frame: Day 2

  9. 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.

06

Results

Posted May 3, 2022

Participant flow

Participant flow — Overall Study
MilestoneAll Patients
Started7
Completed7
Not completed0

Outcome measures

PrimaryExploratory: 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
Reported as:
Mean · percentage of change in IL-2 production
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values
percentage of change in IL-2 productionAll Patients
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values-55.5 ± 5.8
SecondaryThe 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
Reported as:
Count of participants · Participants
The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
ParticipantsAll Patients
The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]3
SecondaryPharmacokinetics (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
Reported as:
Geometric mean · Nanograms/mL
Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion
Nanograms/mLAll Patients
Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion791 ± 47
SecondaryPharmacokinetics (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
Reported as:
Geometric mean · Ng/mL
Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion
Ng/mLAll Patients
Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion109 ± 49
SecondaryPharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge
Time frame:
Day 10, or day of discharge
Reported as:
Geometric mean · Ng/mL
Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge
Ng/mLAll Patients
Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge76 ± 46
SecondaryPharmacokinetics (Plasma Concentration of CM4620): Day 30
Time frame:
Day 30
Reported as:
Geometric mean · Ng/mL
Pharmacokinetics (Plasma Concentration of CM4620): Day 30
Ng/mLAll Patients
Pharmacokinetics (Plasma Concentration of CM4620): Day 3056 ± 32
SecondaryBaseline Levels of IL-6

Included plasma samples collected 1 hour prior to the study drug administration

Time frame:
Baseline
Reported as:
Mean · pg/mL
Baseline Levels of IL-6
pg/mLAll Patients
Baseline Levels of IL-646.04 ± 26.3
SecondaryDay 1: 30 Minutes Post-infusion IL-6 Levels
Time frame:
Day 1
Reported as:
Mean · pg/mL
Day 1: 30 Minutes Post-infusion IL-6 Levels
pg/mLAll Patients
Day 1: 30 Minutes Post-infusion IL-6 Levels40.83 ± 23.29
SecondaryDay 2: 20-hr Post Infusion IL-6 Levels
Time frame:
Day 2
Reported as:
Mean · pg/mL
Day 2: 20-hr Post Infusion IL-6 Levels
pg/mLAll Patients
Day 2: 20-hr Post Infusion IL-6 Levels24.8 ± 12.4
SecondaryPost-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.
Reported as:
Mean · pg/mL
Post-infusion IL-6 Levels at Discharge
pg/mLAll Patients
Post-infusion IL-6 Levels at Discharge13.9 ± 2.0

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
All Patients0/7 (0%)1/7 (14.3%)3/7 (42.9%)
Most frequent serious events
Most frequent serious events
EventAll Patients
Acute PancreatitisGastrointestinal disorders1/7
Respiratory DistressRespiratory, thoracic and mediastinal disorders1/7
Most frequent other events
Most frequent other events
EventAll Patients
MelaenaGastrointestinal disorders1/7
BursitisSkin and subcutaneous tissue disorders1/7
Acute PancreatitisGastrointestinal disorders1/7
PneumoniaRespiratory, thoracic and mediastinal disorders1/7
Alcohol Withdrawal SyndromeGeneral disorders1/7
PyrexiaGeneral disorders1/7
Respiratory DistressRespiratory, thoracic and mediastinal disorders1/7

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Patients
Mean42 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)All Patients
Female2
Male5
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Patients
Hispanic or Latino0
Not Hispanic or Latino7
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Patients
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American4
White3
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Patients
United States7
07

Study locations

1 site
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
08

References and documents

Study documents

  • Study protocol · Sep 25, 2018
  • Statistical analysis plan · May 29, 2019

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

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03709342
Lead sponsor
CalciMedica, Inc.
Responsible party
Sponsor
First posted
Oct 17, 2018
Start date
Jan 6, 2019
Primary completion
Mar 7, 2019
Completion
Jun 7, 2019
Results posted
May 3, 2022
Last update
May 3, 2022

Study contacts

Sudarshan Hebbar, MD
study director · CalciMedica, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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