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CompletedNCT02246595SCIENSUpdated Apr 25, 2016

Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction

A Phase 2 interventional study of CaCP29 and Placebo in Severe Sepsis and Septic Shock, sponsored by InflaRx GmbH. Completed at 11 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-25.

Sponsored by InflaRx GmbH · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. The primary goal of the trial is to assess the pharmacokinetics and pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and tolerability as well as evaluate parameters of efficacy.

02

Conditions studied

  • Severe Sepsis
  • Septic Shock

Keywords

  • Sepsis
  • Severe Sepsis
  • Septic Shock
  • Systemic Inflammatory Response Syndrome
  • Organ Dysfunction
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 72 is below the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

InflaRx GmbH is the lead sponsor of 12 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Key Inclusion Criteria at screening:

  1. Male or female patients >= 18 years old
  2. Written informed consent
  3. Occurrence of at least two criteria of a systemic inflammatory response syndrome (SIRS) not explained by other reasons. These criteria should be present within 12 hours prior to screening
  4. Suspected or confirmed abdominal or pulmonary infection at screening
  5. Broad spectrum i.v. antimicrobial therapy to treat abdominal or pulmonary infection

  6. At least one of the following acute organ dysfunctions due to sepsis. Each organ dysfunction must have occurred within 12 hours prior to screening, cannot mainly be explained by other disease processes than sepsis and is judged by the investigator as being caused or directly related to an abdominal or pulmonary infectious focus:

    1. respiratory
    2. renal
    3. hematologic
    4. metabolic
    5. cardiovascular (occurred within the last three hours)
  7. Reasonable likelihood that administration of study drug can be started within 3.5 hours after start of screening process

Key Exclusion Criteria at screening:

  1. Sepsis of other primary cause than pulmonary or abdominal source
  2. Weight > 130 kg at screening
  3. Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study

  4. Patients receiving the following concomitant medication within 14 days prior to screening:

    1. Calcineurin inhibitors (e.g., ciclosporine, tacrolimus)
    2. Proliferation inhibitors (e.g., everolimus, sirolimus)
    3. Anti-metabolites (e.g., mycophenolate, mycophenolic acid, azathioprine)
    4. High dose corticosteroids (e.g., > 50mg prednisolon per day or equivalent)
  5. Patients receiving high dose immunoglobulins within 3 months prior to screening
  6. Patients with following abnormal laboratory result: Neutrocytopenia with neutrophil count \< 1,000/mm3 unless likely due to sepsis

  7. General criteria:

    1. Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
    2. Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
    3. Participation in any interventional clinical trial within the last three months
    4. Prior participation in this clinical trial
    5. Patient is chronically bed-bound prior to the onset of sepsis
    6. Known intravenous drug abuse
    7. Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
    8. No commitment to full aggressive life support (e.g., do not resuscitate order)

Inclusion criteria

Inclusion Criteria at randomisation:

  1. At least one of the sepsis related organ dysfunction detected at screening is still present
  2. Current treatment with broad spectrum i.v. antibiotics has been started or is ongoing

Exclusion criteria

Exclusion Criteria at randomisation:

  1. Time frame between detection of a non cardiovascular organ dysfunction and start of randomization procedure is more than 15 hours
  2. Time frame between detection of a cardiovascular organ dysfunction and start of randomization is more than six hours
  3. Organ dysfunctions are unlikely to be persistent for next three hours
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    CaCP29

    dose escalating i.v. administration of CaCP29 (verum)

    Biological: CaCP29

  • Placebo comparator
    Placebo

    dose escalation mimicing i.v. placebo treatment:

    Biological: Placebo

Interventions

  • BiologicalCaCP29

    Also known as: IFX-1

  • BiologicalPlacebo
06

What researchers measure

Primary outcomes

  1. Plasma Concentration of CaCP29

    Pharmacokinetic measures include * Plasma concentration over time * Maximum observed concentration per infusion * Concentration measured immediately before next dosing * Area under the curve of plasma concentration per infusion * Mean concentration per infusion * Terminal phase half-life

    Time frame: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28

  2. Assess the pharmacodynamic (PD) effects of CaCP29 on the change from baseline in plasma concentrations of C5a

    Time frame: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28

  3. Safety variables will be summarized using descriptive statistics based on adverse event collection

    Time frame: 28 days

Secondary outcomes

  1. Anti-drug antibodies (ADA)

    The development of ADA will be described by: * Number of patients with detection of anti-drug antibody (ADA) * Number of patients with detection of ADA at each time point measured

    Time frame: 28 days or hospital discharge

  2. All-cause mortality rate

    Time frame: 28 days

  3. Morbidity

    * Mean SOFA until Day 10 * Modified mean SOFA until day 10 (calculated by omitting the Central Nervous System sub-score and calculating the renal subscore without taking urine output into consideration) * Mean SOFA Sub-scores until Day 10 * Days on ICU until Day 28 * Number of patients ventilated until Day 14 * Ventilator-free days until Day 14 * Numbers of patients with renal replacement therapy (RRT) until Day 14 * RRT-free days until Day 14 * Numbers of patients with administration of vasopressor until Day 14 * Vasopressor-free days until Day 14 * Days without antimicrobial therapy (AMT) until Day 14

    Time frame: daily

  4. Fluid balance

    * Mean daily total fluid intake until Day 28 (maximal until ICU discharge) * Mean daily total fluid output until Day 28 (maximal until ICU discharge) * Mean daily fluid balance until Day 28 (maximal until ICU discharge)

    Time frame: 28 days or ICU discharge

  5. Change in routine laboratory parameters as compared to baseline

    Time frame: Days 1, 2, 3, 4, 5, 8, 13, 28

  6. Change in ECG as compared to baseline

    Time frame: Days 2, 4, 8, 28

  7. Change in vital signs as compared to baseline

    Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Day 28

07

Study locations

11 sites
  • Study Site
    Aachen, Germany
  • Study Site
    Augsburg, Germany
  • Study Site
    Bad Saarow, Germany
  • Study Site
    Berlin, Germany
  • Study Site
    Greifswald, Germany
  • Study Site
    Göttingen, Germany
  • Study Site
    Hamburg, Germany
  • Study Site
    Jena, Germany
  • Study Site
    Kiel, Germany
  • Study Site
    Leipzig, Germany
  • Study Site
    Oldenburg, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02246595
Lead sponsor
InflaRx GmbH
Responsible party
Sponsor
First posted
Sep 23, 2014
Start date
Apr 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Apr 25, 2016

Study contacts

Michael Bauer, Prof. Dr.
principal investigator · University Hospital Jena

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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