NCT03158948 is a Phase 2 clinical trial of Nangibotide 0.3 mg/kg in Shock, Septic, sponsored by Inotrem.

Who is sponsoring NCT03158948?

NCT03158948 is sponsored by Inotrem.

What drugs are being tested in NCT03158948?

Interventions in NCT03158948: Nangibotide 0.3 mg/kg, Placebo, Nangibotide 1 mg/kg, Nangibotide 3 mg/kg.

What condition does NCT03158948 study?

NCT03158948 studies Shock, Septic.

Is NCT03158948 still recruiting?

NCT03158948 is currently completed. Last updated 8 October 2024.

Are results published for NCT03158948?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-08 · How we verify

NCT03158948

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock

Completed Phase 2 Results posted Last updated 8 October 2024

What this trial tests

Phase 2 trial testing Nangibotide 0.3 mg/kg in Shock, Septic in 50 participants. Completed in 13 June 2018.

Timeline

3 July 2017

Primary endpoint
13 June 2018

13 June 2018

Quick facts

Lead sponsor	Inotrem
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	3 July 2017
Primary completion	13 June 2018
Estimated completion	13 June 2018
Sites	4 locations across Belgium, France, Netherlands, Spain

Drugs / interventions tested

Nangibotide 0.3 mg/kg — full drug profile →
Placebo
Nangibotide 1 mg/kg — full drug profile →
Nangibotide 3 mg/kg — full drug profile →

Conditions studied

Shock, Septic — all drugs for Shock, Septic →

Sponsor

Inotrem — full company profile →

Who can join

Adults 18 to 80, any sex, with Shock, Septic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion Primary · Adverse events experienced until D28 (End of study visit)

Analyses were performed in the Safety Set composed of all randomized patients who received at least any dose of the study drug (nangibotide or placebo). Adverse events: Summary statistics of treatment emergent adverse events (TEAEs). Clinical events, including death, related to severe sepsis and sepsis complications were exempt from SAE reporting, unless the investigator deemed the event to be related to the administration of the study drug.

Group	Value	95% CI
Nangibotide 0.3 mg/kg/h	12
Nangibotide 1.0 mg/kg/h	12
Nangibotide 3.0 mg/kg/h	11
Placebo	10

Systolic Blood Pressure (SBP) Primary · Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28).

Systolic blood pressure measured by sphygmomanometer at study site. Median SBP at each visit is summarized by treatment group.

Group	Value	95% CI
Placebo	121.5	87 – 149
Nangibotide 0.3 mg/kg/h	110.0	90 – 133
Nangibotide 1.0 mg/kg/h	121.0	96 – 131
Nangibotide 3.0 mg/kg/h	111.0	87 – 160

Group	Value	95% CI
Placebo	114.5	82 – 131
Nangibotide 0.3 mg/kg/h	117.0	96 – 159
Nangibotide 1.0 mg/kg/h	112.5	93 – 124
Nangibotide 3.0 mg/kg/h	113.0	97 – 150

Group	Value	95% CI
Placebo	107.0	104 – 110
Nangibotide 0.3 mg/kg/h	116.0	96 – 147
Nangibotide 1.0 mg/kg/h	121.0	105 – 130
Nangibotide 3.0 mg/kg/h	112.0	100 – 150

Group	Value	95% CI
Placebo	94.0	87 – 101
Nangibotide 0.3 mg/kg/h	126.5	124 – 129
Nangibotide 1.0 mg/kg/h	108.5	96 – 127
Nangibotide 3.0 mg/kg/h	112.5	102 – 123

Group	Value	95% CI
Placebo	108.0	104 – 112
Nangibotide 0.3 mg/kg/h	133.0	133 – 133
Nangibotide 1.0 mg/kg/h	105.0	101 – 125
Nangibotide 3.0 mg/kg/h	107.0	95 – 119

D5/EOI

Group	Value	95% CI
Placebo	117.0	80 – 137
Nangibotide 0.3 mg/kg/h	118.0	94 – 180
Nangibotide 1.0 mg/kg/h	114.5	99 – 170
Nangibotide 3.0 mg/kg/h	109.0	79 – 131

D28/EOS

Group	Value	95% CI
Placebo	135.0	107 – 181
Nangibotide 0.3 mg/kg/h	120.0	90 – 140
Nangibotide 1.0 mg/kg/h	111.0	95 – 166
Nangibotide 3.0 mg/kg/h	113.0	93 – 120

Diastolic Blood Pressure (DBP) Primary · Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28).

Median DBP at each visit is summarized by treatment group.

Group	Value	95% CI
Placebo	53.5	44 – 77
Nangibotide 0.3 mg/kg/h	55.0	40 – 78
Nangibotide 1.0 mg/kg/h	59.0	49 – 78
Nangibotide 3.0 mg/kg/h	55.5	44 – 72

Group	Value	95% CI
Placebo	59.0	45 – 72
Nangibotide 0.3 mg/kg/h	55.0	32 – 75
Nangibotide 1.0 mg/kg/h	59.5	48 – 128
Nangibotide 3.0 mg/kg/h	58.0	44 – 75

Group	Value	95% CI
Placebo	61.0	56 – 66
Nangibotide 0.3 mg/kg/h	63.5	61 – 75
Nangibotide 1.0 mg/kg/h	66.0	58 – 72
Nangibotide 3.0 mg/kg/h	67.0	47 – 86

Group	Value	95% CI
Placebo	58.5	50 – 67
Nangibotide 0.3 mg/kg/h	60.5	60 – 61
Nangibotide 1.0 mg/kg/h	55.5	40 – 62
Nangibotide 3.0 mg/kg/h	62.0	46 – 70

Group	Value	95% CI
Placebo	61.5	55 – 68
Nangibotide 0.3 mg/kg/h	64.0	64 – 64
Nangibotide 1.0 mg/kg/h	55.0	52 – 56
Nangibotide 3.0 mg/kg/h	58.0	46 – 63

D5/EOI

Group	Value	95% CI
Placebo	55.5	46 – 63
Nangibotide 0.3 mg/kg/h	58.0	38 – 95
Nangibotide 1.0 mg/kg/h	57.0	44 – 81
Nangibotide 3.0 mg/kg/h	57.0	30 – 71

D28/EOS

Group	Value	95% CI
Placebo	70.0	40 – 82
Nangibotide 0.3 mg/kg/h	70.0	35 – 90
Nangibotide 1.0 mg/kg/h	60.0	45 – 80
Nangibotide 3.0 mg/kg/h	65.0	60 – 80

Median Arterial Pressure (MAP) Primary · Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28).

MAP at each visit is summarized by treatment group.

Group	Value	95% CI
Placebo	72.0	61 – 101
Nangibotide 0.3 mg/kg/h	71.0	60 – 98
Nangibotide 1.0 mg/kg/h	78.0	67 – 96
Nangibotide 3.0 mg/kg/h	73.0	61 – 116

Group	Value	95% CI
Placebo	77.5	57 – 92
Nangibotide 0.3 mg/kg/h	76.0	60 – 97
Nangibotide 1.0 mg/kg/h	74.0	55 – 87
Nangibotide 3.0 mg/kg/h	77.0	65 – 100

Group	Value	95% CI
Placebo	76.0	69 – 83
Nangibotide 0.3 mg/kg/h	82.5	77 – 105
Nangibotide 1.0 mg/kg/h	80.0	55 – 90
Nangibotide 3.0 mg/kg/h	80.0	67 – 98

Group	Value	95% CI
Placebo	71.0	62 – 80
Nangibotide 0.3 mg/kg/h	84.5	84 – 85
Nangibotide 1.0 mg/kg/h	72.5	54 – 83
Nangibotide 3.0 mg/kg/h	79.0	70 – 88

Group	Value	95% CI
Placebo	76.5	69 – 84
Nangibotide 0.3 mg/kg/h	92.0	92 – 92
Nangibotide 1.0 mg/kg/h	71.0	69 – 74
Nangibotide 3.0 mg/kg/h	77.0	70 – 79

D5/EOI

Group	Value	95% CI
Placebo	75.0	58 – 82
Nangibotide 0.3 mg/kg/h	78.0	61 – 130
Nangibotide 1.0 mg/kg/h	76.0	59 – 112
Nangibotide 3.0 mg/kg/h	72.5	41 – 90

D28/EOS

Group	Value	95% CI
Placebo	87.0	62 – 99
Nangibotide 0.3 mg/kg/h	86.5	52 – 106
Nangibotide 1.0 mg/kg/h	74.0	59 – 107
Nangibotide 3.0 mg/kg/h	79.0	66 – 93

Heart Rate Primary · Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5).

Median heart rate at each visit is summarized by treatment group.

Group	Value	95% CI
Placebo	83.5	54 – 136
Nangibotide 0.3 mg/kg/h	94.0	75 – 138
Nangibotide 1.0 mg/kg/h	104.5	66 – 136
Nangibotide 3.0 mg/kg/h	97.5	85 – 147

Group	Value	95% CI
Placebo	89.0	58 – 145
Nangibotide 0.3 mg/kg/h	86.0	70 – 135
Nangibotide 1.0 mg/kg/h	91.0	65 – 131
Nangibotide 3.0 mg/kg/h	98.0	77 – 135

Group	Value	95% CI
Placebo	74.0	60 – 88
Nangibotide 0.3 mg/kg/h	85.0	80 – 105
Nangibotide 1.0 mg/kg/h	110.0	92 – 132
Nangibotide 3.0 mg/kg/h	83.0	58 – 153

Group	Value	95% CI
Placebo	95.0	70 – 120
Nangibotide 0.3 mg/kg/h	60.5	58 – 63
Nangibotide 1.0 mg/kg/h	102.5	61 – 121
Nangibotide 3.0 mg/kg/h	88.5	64 – 100

Group	Value	95% CI
Placebo	75.0	70 – 80
Nangibotide 0.3 mg/kg/h	61.0	61 – 61
Nangibotide 1.0 mg/kg/h	121.0	100 – 156
Nangibotide 3.0 mg/kg/h	84.5	66 – 96

D5/EOI

Group	Value	95% CI
Placebo	86.0	67 – 129
Nangibotide 0.3 mg/kg/h	91.0	55 – 133
Nangibotide 1.0 mg/kg/h	93.5	58 – 112
Nangibotide 3.0 mg/kg/h	91.0	70 – 122

Temperature Primary · Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5).

Median temperature at each visit is summarized by treatment group.

Group	Value	95% CI
Placebo	37.3	35 – 38.9
Nangibotide 0.3 mg/kg/h	36.8	35.7 – 38.9
Nangibotide 1.0 mg/kg/h	37.0	35.8 – 38.5
Nangibotide 3.0 mg/kg/h	37.0	34 – 39.6

Group	Value	95% CI
Placebo	36.3	35.5 – 40.8
Nangibotide 0.3 mg/kg/h	36.2	33.5 – 39.3
Nangibotide 1.0 mg/kg/h	36.8	36 – 38
Nangibotide 3.0 mg/kg/h	37.1	35.7 – 38.8

Group	Value	95% CI
Placebo	36.1	35.5 – 36.6
Nangibotide 0.3 mg/kg/h	36.3	35.7 – 37
Nangibotide 1.0 mg/kg/h	36.5	36 – 37.4
Nangibotide 3.0 mg/kg/h	37.4	35.1 – 38.9

Group	Value	95% CI
Placebo	36.6	36 – 37.1
Nangibotide 0.3 mg/kg/h	36.3	35.6 – 36.9
Nangibotide 1.0 mg/kg/h	36.7	36.1 – 37.8
Nangibotide 3.0 mg/kg/h	37.4	36.1 – 38.2

Group	Value	95% CI
Placebo	36.1	36 – 36.2
Nangibotide 0.3 mg/kg/h	36.1	36.1 – 36.1
Nangibotide 1.0 mg/kg/h	36.9	36.6 – 37.4
Nangibotide 3.0 mg/kg/h	36.6	36.3 – 37.3

D5/EOI

Group	Value	95% CI
Placebo	36.9	35.8 – 37.3
Nangibotide 0.3 mg/kg/h	36.2	35.6 – 37.9
Nangibotide 1.0 mg/kg/h	36.5	35.4 – 38.6
Nangibotide 3.0 mg/kg/h	36.4	34.3 – 38.3

Electrocardiogram Primary · Electrocardiogram was performed each day from D0 (before IMP initiation) to D5 (EOI) and on D28 (EOS).

Abnormal and emergent clinically significant electrocardiogram were summarized for each group.

ECG - D1

Group	Value	95% CI
Placebo	4
Nangibotide 0.3 mg/kg/h	1
Nangibotide 1.0 mg/kg/h	4
Nangibotide 3.0 mg/kg/h	5
Placebo	3
Nangibotide 0.3 mg/kg/h	4
Nangibotide 1.0 mg/kg/h	4
Nangibotide 3.0 mg/kg/h	5
Placebo	5
Nangibotide 0.3 mg/kg/h	4
Nangibotide 1.0 mg/kg/h	1
Nangibotide 3.0 mg/kg/h	2
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

ECG - D2

Group	Value	95% CI
Placebo	1
Nangibotide 0.3 mg/kg/h	2
Nangibotide 1.0 mg/kg/h	1
Nangibotide 3.0 mg/kg/h	4
Placebo	0
Nangibotide 0.3 mg/kg/h	1
Nangibotide 1.0 mg/kg/h	2
Nangibotide 3.0 mg/kg/h	0
Placebo	1
Nangibotide 0.3 mg/kg/h	1
Nangibotide 1.0 mg/kg/h	2
Nangibotide 3.0 mg/kg/h	2
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

ECG - D3

Group	Value	95% CI
Placebo	0
Nangibotide 0.3 mg/kg/h	1
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	2
Placebo	1
Nangibotide 0.3 mg/kg/h	1
Nangibotide 1.0 mg/kg/h	2
Nangibotide 3.0 mg/kg/h	1
Placebo	1
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	1
Nangibotide 3.0 mg/kg/h	1
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

ECG - D4

Group	Value	95% CI
Placebo	0
Nangibotide 0.3 mg/kg/h	1
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	2
Placebo	1
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	1
Nangibotide 3.0 mg/kg/h	1
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	2
Nangibotide 3.0 mg/kg/h	1
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

ECG - D5/EOI

Group	Value	95% CI
Placebo	3
Nangibotide 0.3 mg/kg/h	3
Nangibotide 1.0 mg/kg/h	4
Nangibotide 3.0 mg/kg/h	4
Placebo	4
Nangibotide 0.3 mg/kg/h	7
Nangibotide 1.0 mg/kg/h	3
Nangibotide 3.0 mg/kg/h	4
Placebo	2
Nangibotide 0.3 mg/kg/h	1
Nangibotide 1.0 mg/kg/h	1
Nangibotide 3.0 mg/kg/h	4
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

ECG - D28/EOS

Group	Value	95% CI
Placebo	3
Nangibotide 0.3 mg/kg/h	5
Nangibotide 1.0 mg/kg/h	4
Nangibotide 3.0 mg/kg/h	4
Placebo	5
Nangibotide 0.3 mg/kg/h	3
Nangibotide 1.0 mg/kg/h	6
Nangibotide 3.0 mg/kg/h	4
Placebo	1
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	1
Nangibotide 3.0 mg/kg/h	1
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

Anti-Drug Antibodies (ADA Dimer) Primary · Anti-Drug Antibodies test were done at D0, D10 and D28 in all patients.

Anti-Drug Antibodies test was performed for all patients.

Group	Value	95% CI
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0
Placebo	12
Nangibotide 0.3 mg/kg/h	13
Nangibotide 1.0 mg/kg/h	12
Nangibotide 3.0 mg/kg/h	12
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

D10

Group	Value	95% CI
Placebo	11
Nangibotide 0.3 mg/kg/h	13
Nangibotide 1.0 mg/kg/h	9
Nangibotide 3.0 mg/kg/h	7
Placebo	1
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	3
Nangibotide 3.0 mg/kg/h	5
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

D28

Group	Value	95% CI
Placebo	3
Nangibotide 0.3 mg/kg/h	4
Nangibotide 1.0 mg/kg/h	2
Nangibotide 3.0 mg/kg/h	3
Placebo	9
Nangibotide 0.3 mg/kg/h	9
Nangibotide 1.0 mg/kg/h	10
Nangibotide 3.0 mg/kg/h	9
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

Anti-Drug Antibodies (ADA Monomer) Primary · Anti-Drug Antibodies test were measured at D0, D10 and D28.

Anti-Drug Antibodies test was performed for all patients.

Group	Value	95% CI
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0
Placebo	12
Nangibotide 0.3 mg/kg/h	13
Nangibotide 1.0 mg/kg/h	12
Nangibotide 3.0 mg/kg/h	12
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

D10

Group	Value	95% CI
Placebo	11
Nangibotide 0.3 mg/kg/h	13
Nangibotide 1.0 mg/kg/h	9
Nangibotide 3.0 mg/kg/h	7
Placebo	1
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	3
Nangibotide 3.0 mg/kg/h	5
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

D28

Group	Value	95% CI
Placebo	3
Nangibotide 0.3 mg/kg/h	5
Nangibotide 1.0 mg/kg/h	2
Nangibotide 3.0 mg/kg/h	3
Placebo	9
Nangibotide 0.3 mg/kg/h	8
Nangibotide 1.0 mg/kg/h	10
Nangibotide 3.0 mg/kg/h	9
Placebo	0
Nangibotide 0.3 mg/kg/h	0
Nangibotide 1.0 mg/kg/h	0
Nangibotide 3.0 mg/kg/h	0

Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax Secondary · Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI

As no pharmacokinetic sample was planned just after the loading dose, maximum observed nangibotide plasma concentration (Cmax) was in the same magnitude as steady-state concentration during the maintenance infusion, calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study (Cavg).

Group	Value	95% CI
Nangibotide 0.3 mg/kg/h	71.2	20.0 – 219
Nangibotide 1.0 mg/kg/h	234	71.3 – 514
Nangibotide 3.0 mg/kg/h	914	502 – 6095

Pharmacokinetic Parameters From the Non-compartmental Analysis: Tmax Secondary · Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI

Time to reach the maximum observed nangibotide plasma concentration (h) was measured for all groups.

Group	Value	95% CI
Nangibotide 0.3 mg/kg/h	22.7	14.3 – 76.0
Nangibotide 1.0 mg/kg/h	25.4	9.25 – 118
Nangibotide 3.0 mg/kg/h	36.0	9.00 – 75.8

Pharmacokinetic Parameters From the Non-compartmental Analysis: AUC0-last Secondary · Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI

Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration Clast was calculated using the log-linear trapezoidal method.

Group	Value	95% CI
Nangibotide 0.3 mg/kg/h	1722	360 – 5243
Nangibotide 1.0 mg/kg/h	7579	668 – 45189
Nangibotide 3.0 mg/kg/h	47320	3830 – 393506

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline until D28. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 7/12 (58%)

Deaths: 3/12

Nangibotide 0.3 mg/kg/h

Serious: 4/13 (31%)

Deaths: 4/13

Nangibotide 1.0 mg/kg/h

Serious: 2/12 (17%)

Deaths: 2/12

Nangibotide 3.0 mg/kg/h

Serious: 4/12 (33%)

Deaths: 4/12

Serious adverse events (19 terms)

Reaction	System	Placebo	Nangibotide 0.3 mg/kg/h	Nangibotide 1.0 mg/kg/h	Nangibotide 3.0 mg/kg/h
Pneumonia	Infections and infestations	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—	—
Encephalitis	Infections and infestations	—	—	—	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—	—	—	—
Multiple organ failure syndrome	General disorders	—	—	—	—
Haemodynamic instability	Vascular disorders	—	—	—	—
Intestinal ischaemia	Gastrointestinal disorders	—	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—	—
Peripheral ischaemia	Vascular disorders	—	—	—	—
Cardiac infection	Infections and infestations	—	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—	—
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Mechanical ventilation complication	Injury, poisoning and procedural complications	—	—	—	—
Shock	Vascular disorders	—	—	—	—
Acute coronary syndrome	Cardiac disorders	—	—	—	—
Epilepsy	Nervous system disorders	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—
Respiratory fatigue	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (18 terms — click to expand)

Reaction	System	Placebo	Nangibotide 0.3 mg/kg/h	Nangibotide 1.0 mg/kg/h	Nangibotide 3.0 mg/kg/h
Atrial fibrillation	Cardiac disorders	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Bronchitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Arrhythmia	Cardiac disorders	—	—	—	—
Confusional State	Nervous system disorders	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—
Intra-Abdominal Fluid Collection	Gastrointestinal disorders	—	—	—	—
Oral Fungal Infection	Infections and infestations	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—
Infectious Pleural Effusion	Infections and infestations	—	—	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Agitation	Psychiatric disorders	—	—	—	—
Renal Failure	Renal and urinary disorders	—	—	—	—
Septic Shock	Infections and infestations	—	—	—	—

Most-reported serious reactions: Pneumonia, Septic shock, Cardio-respiratory arrest, Encephalitis, Post procedural haemorrhage, Multiple organ failure syndrome, Haemodynamic instability, Intestinal ischaemia.

Data from ClinicalTrials.gov NCT03158948 adverse events section.

Sponsor's own description

This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients with septic shock.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Treatment Advances in Sepsis and Septic Shock: Modulating Pro- and Anti-Inflammatory Mechanisms.
Marques A, Torre C, Pinto R, Sepodes B, et al · · 2023 · cited 42× · PMID 37109229 · DOI 10.3390/jcm12082892
A first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition.
Cuvier V, Lorch U, Witte S, Olivier A, et al · · 2018 · cited 32× · PMID 29885068 · DOI 10.1111/bcp.13668
Serum sTREM-1 in adult-onset Still's disease: a novel biomarker of disease activity and a potential predictor of the chronic course.
Wang Z, Chi H, Sun Y, Teng J, et al · · 2020 · cited 16× · PMID 32276274 · DOI 10.1093/rheumatology/keaa135
Proceedings of Réanimation 2019, the French Intensive Care Society International Congress.
· 2019 · cited 10× · PMID 30924032 · DOI 10.1186/s13613-018-0474-7
Long-term immunosuppressive treatment is not associated with worse outcome in patients hospitalized in the intensive care unit for septic shock: the PACIFIC study.
Vaidie J, Peju E, Jandeaux LM, Lesouhaitier M, et al · · 2023 · cited 7× · PMID 37660107 · DOI 10.1186/s13054-023-04626-z
Sepsis 2018 : Bangkok, Thailand. 1-3 October 2018.
· 2018 · cited 6× · PMID 30270404 · DOI 10.1186/s40635-018-0196-z
Proceedings of Réanimation 2018, the French Intensive Care Society International Congress.
· 2018 · cited 6× · PMID 29404789 · DOI 10.1186/s13613-017-0345-7
Sepsis 2017 Paris : Paris, France. September 11-13, 2017.
· 2017 · cited 4× · PMID 28895108 · DOI 10.1186/s40635-017-0149-y

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Other Inotrem trials

Trials by the same sponsor.

NCT06580418 — Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model · recruiting
NCT04429334 — Efficacy and Safety Study of Nangibotide in Patients With COVID-19 Receiving Ventilatory Support · Phase 2 · completed
NCT04055909 — Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock · Phase 2 · active not recruiting
NCT03463044 — Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03158948 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inotrem
Last refreshed: 8 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03158948.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03158948

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (19 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Shock, Septic

Other Inotrem trials

Verify against primary sources