Shock, SepticPhase 2NCT03158948

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

A Phase 2 study testing Nangibotide 0.3 mg/kg, Nangibotide 1 mg/kg and Nangibotide 3 mg/kg in people with Shock, Septic, run by Inotrem at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Shock, Septic
What is being tested?: Nangibotide 0.3 mg/kg, Nangibotide 1 mg/kg and Nangibotide 3 mg/kg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 4 sitesin 4 countries
Study dates: 3 Jul 2017to 13 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide written informed consent (proxy/legal representative) according to local regulations
Age 18 to 80 years
Documented or suspected infection: lung, abdominal or elderly UTI (≥65 years)
Organ dysfunction defined as acute change in SOFA score ≥ 2 points
Refractory hypotension requiring vasopressors to maintain MAP ≥65mm Hg despite adequate volume resuscitation of at least 20 ml/kg within 6 hours
Hyperlactatemia (blood lactate >2 mmol/L or 18 mg/dL). This criterion must be met at least once for the purpose of diagnosis within the 24 hours before study drug administration

Who cannot join

Previous episode of septic shock (vasopressor administration) within current hospital stay
Underlying concurrent immunodepression (specified in appendix 2)
Solid organ transplant requiring immunosuppressive therapy
Known pregnancy (positive serum pregnancy test)
Prolonged QT syndrome (QTc ≥ 440 ms)
Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding

Show all 17Show fewer

Ongoing documented or suspected endocarditis, history of prosthetic heart valves
End-stage neurological disease
End-stage cirrhosis (Child Pugh Class C)
Acute Physiology And Chronic Health Evaluation (APACHE) II score ≥ 34
End stage chronic renal disease requiring chronic dialysis
Home oxygen therapy on a regular basis for > 6 h/day
Severe obesity (BMI ≥ 40)
Recent CPR (within current hospital stay)
Moribund patients
Decision to limit full care taken before obtaining informed consent
Participation in another interventional study in the 3 months prior to randomisation

Trial locations and contacts

4 sites in 4 countries.

Country

City, postcode or hospital

4 sites in 4 countries

Belgium1 site

Cliniques Universitaires Saint-Luc (there may be other sites in this country)
Brussels

Other trials in Belgium

France1 site

Inserm Clinical Investigational Center, CHU Dupuytren (there may be other sites in this country)
Limoges

Other trials in France

Netherlands1 site

Radboudumc (there may be other sites in this country)
Nijmegen

Other trials in Netherlands

Spain1 site

Hospital Clínico San Carlos, Medicina Intensiva (there may be other sites in this country)
Madrid

Other trials in Spain

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock. A Randomised, Double-blind, Two-Stage, Placebo Controlled Study

Read the detailed description

This was a randomised, double-blind, two-stage, placebo-controlled study. It was composed of 2 stages with a similar treatment regimen in which 0.3, 1.0 or 3.0 mg/kg/h of nangibotide was tested versus placebo.

Stage 1 was performed to investigate ascending doses of nangibotide or placebo in a sequential design in cohorts of 4 patients (3:1 randomisation). After completion of a cohort (for up to 5 days of infusion), safety and available PK data were blindly reviewed by an independent data safety monitoring board (DSMB) before progressing to the next cohort. After completion of stage 1 DSMB evaluation, the study progressed to stage 2.

Stage 2 investigated 3 doses of nangibotide in a randomised, balanced, parallel-group design involving up to 3 doses of nangibotide and a placebo arm. Only dose arms of nangibotide considered to be safe and well tolerated during Stage 1 were to be administered in Stage 2.

Conditions: Shock, Septic
Being tested: Nangibotide 0.3 mg/kg, Placebo, Nangibotide 1 mg/kg, Nangibotide 3 mg/kg
Keywords: Sepsis, LR12, TREM1, TREM-1
Medical subject headings: Shock, Septic, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nangibotide 0.3 mg/kgDrug
Also called MOTREM 0.3 mg/kg
Formulated LR12 peptide
PlaceboDrug
placebo
Nangibotide 1 mg/kgDrug
Also called MOTREM 1 mg/kg
Formulated LR12 peptide
Nangibotide 3 mg/kgDrug
Also called MOTREM 3 mg/kg
Formulated LR12 peptide

Study groups in NCT03158948
Study group	Role	What they receive
nangibotide 0.3 mg/kg/h	Experimental	Not described Receives: Drug: Nangibotide 0.3 mg/kg
nangibotide 1.0 mg/kg/h	Experimental	Not described Receives: Drug: Nangibotide 1 mg/kg
nangibotide 3.0 mg/kg/h	Experimental	Not described Receives: Drug: Nangibotide 3 mg/kg
Placebo to nangibotide	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion
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.
Measured: Adverse events experienced until D28 (End of study visit)
Systolic Blood Pressure (SBP)
Systolic blood pressure measured by sphygmomanometer at study site. Median SBP at each visit is summarized by treatment group.
Measured: 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).
Diastolic Blood Pressure (DBP)
Median DBP at each visit is summarized by treatment group.
Measured: 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 Arterial Pressure (MAP)
MAP at each visit is summarized by treatment group.
Measured: 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).
Heart Rate
Median heart rate at each visit is summarized by treatment group.
Measured: Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5).
Temperature
Median temperature at each visit is summarized by treatment group.
Measured: Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5).
Electrocardiogram
Abnormal and emergent clinically significant electrocardiogram were summarized for each group.
Measured: Electrocardiogram was performed each day from D0 (before IMP initiation) to D5 (EOI) and on D28 (EOS).
Anti-Drug Antibodies (ADA Dimer)
Anti-Drug Antibodies test was performed for all patients.
Measured: Anti-Drug Antibodies test were done at D0, D10 and D28 in all patients.
Anti-Drug Antibodies (ADA Monomer)
Anti-Drug Antibodies test was performed for all patients.
Measured: Anti-Drug Antibodies test were measured at D0, D10 and D28.

Secondary outcomes (5)

Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax
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).
Measured: 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
Pharmacokinetic Parameters From the Non-compartmental Analysis: Tmax
Time to reach the maximum observed nangibotide plasma concentration (h) was measured for all groups.
Measured: 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
Pharmacokinetic Parameters From the Non-compartmental Analysis: AUC0-last
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration Clast was calculated using the log-linear trapezoidal method.
Measured: 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
Pharmacokinetic Parameters From the Non-compartmental Analysis: Cavg
Steady-state concentration during the maintenance infusion was calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study.
Measured: 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
Pharmacokinetic Parameters From the Non-compartmental Analysis: CL
Systemic clearance was calculated as the ratio between the infusion rate during the maintenance infusion and Cavg.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 201713 Jun 2018

First posted18 May 2017
Study start3 Jul 2017
Primary completion13 Jun 2018
Study completion13 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Shock, SepticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomised, Double-blind, Two-Stage, Placebo Controlled
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03158948
Sponsor's protocol ID: MOT-C-201
Status last verified: Jul 2024
First submitted: 16 May 2017
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Shock, Septic trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock. A Randomised, Double-blind, Two-Stage, Placebo Controlled Study
ClinicalTrials.gov ID: NCT03158948
Acronym / sponsor ID: MOT-C-201
Conditions: Shock, Septic
Keywords: Sepsis, LR12, TREM1, TREM-1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: InotremIndustry (pharma, biotech, devices)
Study start: 3 Jul 2017 (actual)
Primary completion: 13 Jun 2018 (actual)
Study completion: 13 Jun 2018 (actual)
First posted: 18 May 2017 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Randomised, Double-blind, Two-Stage, Placebo Controlled

Arm	Type	Receives
nangibotide 0.3 mg/kg/h	Experimental	Drug: Nangibotide 0.3 mg/kg
nangibotide 1.0 mg/kg/h	Experimental	Drug: Nangibotide 1 mg/kg
nangibotide 3.0 mg/kg/h	Experimental	Drug: Nangibotide 3 mg/kg
Placebo to nangibotide	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provide written informed consent (proxy/legal representative) according to local regulations
Age 18 to 80 years
Documented or suspected infection: lung, abdominal or elderly UTI (≥65 years)
Organ dysfunction defined as acute change in SOFA score ≥ 2 points
Refractory hypotension requiring vasopressors to maintain MAP ≥65mm Hg despite adequate volume resuscitation of at least 20 ml/kg within 6 hours

Key exclusion criteria (17 listed)

Previous episode of septic shock (vasopressor administration) within current hospital stay
Underlying concurrent immunodepression (specified in appendix 2)
Solid organ transplant requiring immunosuppressive therapy
Known pregnancy (positive serum pregnancy test)
Prolonged QT syndrome (QTc ≥ 440 ms)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nangibotide 0.3 mg/kgAlso: MOTREM 0.3 mg/kgFormulated LR12 peptide	Drug	nangibotide 0.3 mg/kg/h
Placeboplacebo	Drug	Placebo to nangibotide
Nangibotide 1 mg/kgAlso: MOTREM 1 mg/kgFormulated LR12 peptide	Drug	nangibotide 1.0 mg/kg/h
Nangibotide 3 mg/kgAlso: MOTREM 3 mg/kgFormulated LR12 peptide	Drug	nangibotide 3.0 mg/kg/h

Primary outcome

Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion
Time frame: 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.
Systolic Blood Pressure (SBP)
Time frame: 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.
Diastolic Blood Pressure (DBP)
Time frame: 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.
Median Arterial Pressure (MAP)
Time frame: 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.
Heart Rate
Time frame: 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.
Temperature
Time frame: 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.
Electrocardiogram
Time frame: 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.
Anti-Drug Antibodies (ADA Dimer)
Time frame: Anti-Drug Antibodies test were done at D0, D10 and D28 in all patients.
Anti-Drug Antibodies test was performed for all patients.
Anti-Drug Antibodies (ADA Monomer)
Time frame: Anti-Drug Antibodies test were measured at D0, D10 and D28.
Anti-Drug Antibodies test was performed for all patients.

5 secondary outcomes

Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax
Time frame: 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
Pharmacokinetic Parameters From the Non-compartmental Analysis: Tmax
Time frame: 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
Pharmacokinetic Parameters From the Non-compartmental Analysis: AUC0-last
Time frame: 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
Pharmacokinetic Parameters From the Non-compartmental Analysis: Cavg
Time frame: 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
Pharmacokinetic Parameters From the Non-compartmental Analysis: CL
Time frame: 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

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nangibotide 0.3 mg/kg/h	13	12
Nangibotide 1.0 mg/kg/h	12	11
Nangibotide 3.0 mg/kg/h	12	9
Placebo	12	9

Primary outcome: Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion

Time frame: Adverse events experienced until D28 (End of study visit). Count of participants. Unit: Participants

Measure	Nangibotide 0.3 mg/kg/h n = 13	Nangibotide 1.0 mg/kg/h n = 12	Nangibotide 3.0 mg/kg/h n = 12	Placebo n = 12
Value	12	12	11	10

Population analysed: Out of 49 patients included in all 4 groups, TEAEs were observed for 45 patients (12 patients experienced TEAEs in MOTREM 1 group, 12 patients experienced TEAEs in MOTREM 2 group, 11 patients experienced TEAEs in MOTREM 3 group and 10 patients experienced TEAEs in placebo group)

Primary outcome: Systolic Blood Pressure (SBP)

Time frame: 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 (Full Range). Unit: mmHg

Measure	Placebo n = 12	Nangibotide 0.3 mg/kg/h n = 13	Nangibotide 1.0 mg/kg/h n = 12	Nangibotide 3.0 mg/kg/h n = 12
D0	121.5 (87 to 149)	110.0 (90 to 133)	121.0 (96 to 131)	111.0 (87 to 160)
D1	114.5 (82 to 131)	117.0 (96 to 159)	112.5 (93 to 124)	113.0 (97 to 150)
D2	107.0 (104 to 110)	116.0 (96 to 147)	121.0 (105 to 130)	112.0 (100 to 150)
D3	94.0 (87 to 101)	126.5 (124 to 129)	108.5 (96 to 127)	112.5 (102 to 123)
D4	108.0 (104 to 112)	133.0 (133 to 133)	105.0 (101 to 125)	107.0 (95 to 119)
D5/EOI	117.0 (80 to 137)	118.0 (94 to 180)	114.5 (99 to 170)	109.0 (79 to 131)
D28/EOS	135.0 (107 to 181)	120.0 (90 to 140)	111.0 (95 to 166)	113.0 (93 to 120)

Population analysed: The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit.

Primary outcome: Diastolic Blood Pressure (DBP)

Measure	Placebo n = 12	Nangibotide 0.3 mg/kg/h n = 13	Nangibotide 1.0 mg/kg/h n = 12	Nangibotide 3.0 mg/kg/h n = 12
D0	53.5 (44 to 77)	55.0 (40 to 78)	59.0 (49 to 78)	55.5 (44 to 72)
D1	59.0 (45 to 72)	55.0 (32 to 75)	59.5 (48 to 128)	58.0 (44 to 75)
D2	61.0 (56 to 66)	63.5 (61 to 75)	66.0 (58 to 72)	67.0 (47 to 86)
D3	58.5 (50 to 67)	60.5 (60 to 61)	55.5 (40 to 62)	62.0 (46 to 70)
D4	61.5 (55 to 68)	64.0 (64 to 64)	55.0 (52 to 56)	58.0 (46 to 63)
D5/EOI	55.5 (46 to 63)	58.0 (38 to 95)	57.0 (44 to 81)	57.0 (30 to 71)
D28/EOS	70.0 (40 to 82)	70.0 (35 to 90)	60.0 (45 to 80)	65.0 (60 to 80)

Primary outcome: Median Arterial Pressure (MAP)

Measure	Placebo n = 12	Nangibotide 0.3 mg/kg/h n = 13	Nangibotide 1.0 mg/kg/h n = 12	Nangibotide 3.0 mg/kg/h n = 12
D0	72.0 (61 to 101)	71.0 (60 to 98)	78.0 (67 to 96)	73.0 (61 to 116)
D1	77.5 (57 to 92)	76.0 (60 to 97)	74.0 (55 to 87)	77.0 (65 to 100)
D2	76.0 (69 to 83)	82.5 (77 to 105)	80.0 (55 to 90)	80.0 (67 to 98)
D3	71.0 (62 to 80)	84.5 (84 to 85)	72.5 (54 to 83)	79.0 (70 to 88)
D4	76.5 (69 to 84)	92.0 (92 to 92)	71.0 (69 to 74)	77.0 (70 to 79)
D5/EOI	75.0 (58 to 82)	78.0 (61 to 130)	76.0 (59 to 112)	72.5 (41 to 90)
D28/EOS	87.0 (62 to 99)	86.5 (52 to 106)	74.0 (59 to 107)	79.0 (66 to 93)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline until D28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	7 of 12 (58.3%)	10 of 12 (83.3%)	3 of 12
Nangibotide 0.3 mg/kg/h	4 of 13 (30.8%)	12 of 13 (92.3%)	4 of 13
Nangibotide 1.0 mg/kg/h	2 of 12 (16.7%)	12 of 12 (100%)	2 of 12
Nangibotide 3.0 mg/kg/h	4 of 12 (33.3%)	11 of 12 (91.7%)	4 of 12

Limitations and caveats (from the sponsor): None reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruno François, MD principal investigator

Inserm 1435 Clinical Investigational Center, Limoges, France

4 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nangibotide 0.3 mg/kg, Nangibotide 1 mg/kg and Nangibotide 3 mg/kg in people with Shock, Septic, run by Inotrem at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, France, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion (time frame: Adverse events experienced until D28 (End of study visit)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03158948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.