Phase 2
N=301
Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB
Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT03085758 ↗Enrolled (actual)
301
Serious AEs
61.1%
Results posted
Mar 2021
Primary outcome: Primary: Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality) — 63.1453; 63.1578; 64.5744; 63.9809 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Adrecizumab (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Adrenomed AG
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality) |
63.1453; 63.1578; 64.5744; 63.9809 | — |
| PRIMARY Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Interruption of Infusion) |
0; 1; 1; 0 | — |
| PRIMARY Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Frequency of TEAEs) |
68; 74; 142; 142 | — |
| PRIMARY Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Mild Severity |
39; 46; 85; 82 | — |
| PRIMARY Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Moderate Severity |
54; 60; 114; 109 | — |
| PRIMARY Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Severity and Frequency of TEAEs) - Severe Severity |
51; 54; 105; 108 | — |
| SECONDARY Efficacy to be Determined by Sepsis Support Index (SSI) |
8.4; 9.1; 8.8; 8.1 | — |
| SECONDARY Sepsis Support Index (SSI) |
13.3; 14.6; 14.0; 12.8 | — |
| SECONDARY Penalized Sepsis Support Index (pSSI) at 14 Day Follow-up |
8.5; 9.1; 8.8; 8.1 | — |
| SECONDARY Persistent Organ Dysfunction or Death at 14 and 28 Day Follow-up |
29; 37; 66; 63; 25; 25 | — |
| SECONDARY Mortality Rate |
20.3484; 17.5630; 20.5162; 22.8783 | — |
| SECONDARY SSI and pSSI Excluding the Renal Component |
8.0; 9.0; 8.5; 7.9; 12.9; 14.3 | — |
| SECONDARY SSI Weighted for Mortality |
10.2; 10.7; 10.5; 9.9 | — |
| SECONDARY Individual Sepsis Support Index Components |
4.0; 5.4; 4.7; 4.6; 4.8; 5.8 | — |
| SECONDARY Sequential Organ Failure Assessment (SOFA) Score : Composite Measure: SOFA Score and Its Changes Over Time |
-0.9; -0.2; -0.5; 0.3; 4.2; 4.8 | — |
| SECONDARY Change in Renal Function (Creatinine) |
-27.9; -11.7; -27.9; -25.6; -46.6; -44.9 | — |
| SECONDARY Duration of Stay at ICU/ Hospital |
12.3; 13.4; 12.8; 11.2; 9.6; 11.0 | — |
| SECONDARY Changes of Functional Parameter Mean Arterial Pressure During Stay at ICU |
-7.2; -6.2; -6.7; -6.4; 18.9; 17.9 | — |
| SECONDARY Changes of Functional Parameter Creatinine During Stay at ICU |
189.649; 199.891; 194.944; 192.801; 84.217; 79.488 | — |
| SECONDARY Changes of Functional Parameter Partial Pressure of Oxygen in Arterial Blood(PaO2) / Fraction of Inspired Oxygen (FiO2) During Stay at ICU |
39.83; 63.80; 52.08; 15.91 | — |
| SECONDARY Changes of Functional Parameter Blood Lactate During Stay at ICU |
-1.94; -1.54; -1.74; -1.49 | — |
| SECONDARY Changes of Functional Parameter Fluid Balance During Stay at ICU |
80.6; 84.4; 82.6; 80.9; 19.4; 15.6 | — |
| SECONDARY Changes of Functional Parameter Mid-Regional Pro-Adrenomedullin (MR-proADM) During Stay at ICU |
-5.029; -4.608; -4.815; -4.030 | — |
| SECONDARY Changes of Functional Parameter Inflammatory Marker Procalcitonine (PCT) During Stay at ICU |
-41.402; -52.661; -47.208; -37.219 | — |
| SECONDARY Changes of Functional Parameter Inflammatory Marker Interleukin-6 (IL-6) During Stay at ICU |
-27648.3; -37780.4; -32872.7; -26236.2 | — |
| SECONDARY Changes of Functional Parameter Dipeptidyl Peptidase 3 (DPP3) During Stay at ICU |
-11.56; -12.47; -12.03; -9.38 | — |
| SECONDARY Vasopressor Use (Drug, Highest Dose) |
1.1236; 2.1319; 1.5018; 1.9888; 1.1236; 2.1319 | — |
| SECONDARY Patient Reported Outcomes : Quality of Life by Euro-QoL-5 |
-13.4; -19.3; -16.5; -7.6; -11.8; -10.2 | — |
| SECONDARY Vital Signs |
5.6; 4.3; 4.9; 13.5; -27.2; -18.5 | — |
| SECONDARY Penalized Sepsis Support Index (pSSI) at 28 Day Follow-up |
13.8; 14.8; 14.3; 13.2 | — |
| SECONDARY Vasopressor Use (Drug, Duration) |
1.67; 1.50; 1.60; 1.78; 1.67; 1.50 | — |
| SECONDARY Change in Renal Function (penKid) |
-28.3; -21.4; -24.8; -34.8; -19.5; -19.7 | — |
| SECONDARY Vital Signs - Blood Pressure |
29.5; 28.2; 28.8; 31.7; -9.6; -6.5 | — |
Summary
This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.
Eligibility Criteria
Inclusion Criteria
- Written informed consent by patient or legal representative (according to country - specific regulations)
- Male and female patient, age ≥ 18 years
- Body weight 50 kg - 120 kg
- Bio-ADM concentration > 70 pg/ml
- Patient with early septic shock (start of vasopressor therapy 30% of body surface
- Plasmapheresis
- Breastfeeding women
- Participation in a clinical trial involving another investigational drug within 4 weeks prior to inclusion
- Unwilling or unable to be fully evaluated for all follow-up visits
Data sourced from ClinicalTrials.gov (NCT03085758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.