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Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia

Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03027609
Enrollment
158
Registered
2017-01-23
Start date
2017-03-29
Completion date
2019-04-25
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudomonas Aeruginosa Pneumonia

Keywords

Pseudomonas aeruginosa, pneumonia

Brief summary

Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.

Detailed description

This is a double-blind, randomized, placebo-controlled study of the human monoclonal antibody (mAb) AR-105 for the adjunctive therapeutic treatment of P. aeruginosa pneumonia in mechanically ventilated subjects. Subjects who are randomized will be treated with either standard of care (SOC) antibiotics plus placebo or SOC antibiotics plus AR-105. The study is being conducted at approximately 100 clinical sites across 17 countries. Subjects who meet all of the inclusion criteria and none of the exclusion criteria are screened by the microbiological culture test and/or rapid diagnostic test of an endotracheal aspirate to confirm the presence of an active P. aeruginosa infection. Following eligibility confirmation, the subject will be randomized in a 1:1 ratio to one of two treatment groups.

Interventions

DRUGAR-105

monoclonal antibody

DRUGPlacebo

matching placebo (+ SOC antibiotics)

Sponsors

Aridis Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Informed consent * ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only) * pneumonia due to P. aeruginosa * mechanically-ventilated * intubated * APACHE II score between 10 and 35

Exclusion criteria

(main criteria): * being moribund * effective antibiotic therapy ≥48 hours * immunocompromised * underlying pulmonary disease that may preclude the assessment of a therapeutic response

Design outcomes

Primary

MeasureTime frameDescription
Clinical Cure on Day 2121 days following dosingA summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group

Secondary

MeasureTime frameDescription
Clinical Cure on Day 77 days following dosingA summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group
Clinical Cure on Day 1414 days following dosingA summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group
Clinical Cure on Day 2828 days following dosingA summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group

Countries

Australia, Belarus, Belgium, Czechia, France, Georgia, Greece, Hungary, Mexico, Peru, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United States

Participant flow

Participants by arm

ArmCount
AR-105
One intravenous infusion of AR-105 20mg/'kg AR-105: monoclonal antibody
79
Control
Matching placebo placebo: matching placebo
79
Total158

Baseline characteristics

CharacteristicAR-105ControlTotal
Age, Continuous63.5 years
STANDARD_DEVIATION 13.83
61.2 years
STANDARD_DEVIATION 15.58
62.3 years
STANDARD_DEVIATION 14.73
Age, Customized
Age </= 64 years
40 Participants39 Participants79 Participants
Age, Customized
Age > 64 years
39 Participants40 Participants79 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants4 Participants8 Participants
Race (NIH/OMB)
Black or African American
2 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
73 Participants74 Participants147 Participants
Region of Enrollment
Belarus
7 participants5 participants12 participants
Region of Enrollment
Belgium
3 participants3 participants6 participants
Region of Enrollment
Czechia
5 participants5 participants10 participants
Region of Enrollment
France
10 participants14 participants24 participants
Region of Enrollment
Georgia
1 participants0 participants1 participants
Region of Enrollment
Greece
5 participants2 participants7 participants
Region of Enrollment
Hungary
10 participants8 participants18 participants
Region of Enrollment
Russia
21 participants21 participants42 participants
Region of Enrollment
South Korea
2 participants0 participants2 participants
Region of Enrollment
Spain
4 participants3 participants7 participants
Region of Enrollment
Taiwan
2 participants3 participants5 participants
Region of Enrollment
Ukraine
6 participants11 participants17 participants
Region of Enrollment
United States
3 participants4 participants7 participants
Sex: Female, Male
Female
17 Participants21 Participants38 Participants
Sex: Female, Male
Male
62 Participants58 Participants120 Participants
World Regions
Americas
3 Participants4 Participants7 Participants
World Regions
Asia
4 Participants3 Participants7 Participants
World Regions
Eastern Europe
50 Participants50 Participants100 Participants
World Regions
Western Europe
22 Participants22 Participants44 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
25 / 7913 / 79
other
Total, other adverse events
73 / 7973 / 79
serious
Total, serious adverse events
36 / 7922 / 79

Outcome results

Primary

Clinical Cure on Day 21

A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group

Time frame: 21 days following dosing

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AR-105Clinical Cure on Day 21Observed Cured34 Participants
AR-105Clinical Cure on Day 21Imputed Cured6 Participants
AR-105Clinical Cure on Day 21Not Cured25 Participants
AR-105Clinical Cure on Day 21Reinfection same pathogen5 Participants
AR-105Clinical Cure on Day 21New Infection Different Pathogen0 Participants
AR-105Clinical Cure on Day 21New infection Unknown pathogen0 Participants
ControlClinical Cure on Day 21New Infection Different Pathogen3 Participants
ControlClinical Cure on Day 21Observed Cured37 Participants
ControlClinical Cure on Day 21Reinfection same pathogen2 Participants
ControlClinical Cure on Day 21Imputed Cured5 Participants
ControlClinical Cure on Day 21New infection Unknown pathogen0 Participants
ControlClinical Cure on Day 21Not Cured20 Participants
p-value: 0.615495% CI: [-21.9, 10.8]Cochran-Mantel-Haenszel
Secondary

Clinical Cure on Day 14

A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group

Time frame: 14 days following dosing

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AR-105Clinical Cure on Day 14New Infection Different Pathogen2 Participants
AR-105Clinical Cure on Day 14Reinfection same pathogen1 Participants
AR-105Clinical Cure on Day 14Imputed Cured1 Participants
AR-105Clinical Cure on Day 14Observed Cured36 Participants
AR-105Clinical Cure on Day 14New infection Unknown Pathogen1 Participants
AR-105Clinical Cure on Day 14Not Cured29 Participants
ControlClinical Cure on Day 14New infection Unknown Pathogen0 Participants
ControlClinical Cure on Day 14Reinfection same pathogen0 Participants
ControlClinical Cure on Day 14New Infection Different Pathogen4 Participants
ControlClinical Cure on Day 14Not Cured30 Participants
ControlClinical Cure on Day 14Imputed Cured2 Participants
ControlClinical Cure on Day 14Observed Cured31 Participants
Comparison: Comparison between the treatment and placebop-value: 0.356295% CI: [-13.1, 20.3]Cochran-Mantel-Haenszel
Secondary

Clinical Cure on Day 28

A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group

Time frame: 28 days following dosing

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AR-105Clinical Cure on Day 28Observed Cured35 Participants
AR-105Clinical Cure on Day 28Reinfection same pathogen3 Participants
AR-105Clinical Cure on Day 28New Infection Different Pathogen0 Participants
AR-105Clinical Cure on Day 28Imputed Cured9 Participants
AR-105Clinical Cure on Day 28Not Cured23 Participants
AR-105Clinical Cure on Day 28New infection Unknown Pathogen0 Participants
ControlClinical Cure on Day 28New Infection Different Pathogen4 Participants
ControlClinical Cure on Day 28Not Cured16 Participants
ControlClinical Cure on Day 28Imputed Cured6 Participants
ControlClinical Cure on Day 28Reinfection same pathogen3 Participants
ControlClinical Cure on Day 28New infection Unknown Pathogen0 Participants
ControlClinical Cure on Day 28Observed Cured38 Participants
p-value: 0.847295% CI: [-18.9, 13.2]Cochran-Mantel-Haenszel
Secondary

Clinical Cure on Day 7

A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group

Time frame: 7 days following dosing

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AR-105Clinical Cure on Day 7Cured Observed16 Participants
AR-105Clinical Cure on Day 7Cured Imputed0 Participants
AR-105Clinical Cure on Day 7Not Cured52 Participants
AR-105Clinical Cure on Day 7Re-infection Same Pathogen1 Participants
AR-105Clinical Cure on Day 7New Infection Different Pathogen1 Participants
AR-105Clinical Cure on Day 7New Infection Unknown Pathogen0 Participants
ControlClinical Cure on Day 7New Infection Different Pathogen1 Participants
ControlClinical Cure on Day 7Cured Observed18 Participants
ControlClinical Cure on Day 7Re-infection Same Pathogen0 Participants
ControlClinical Cure on Day 7Cured Imputed0 Participants
ControlClinical Cure on Day 7New Infection Unknown Pathogen1 Participants
ControlClinical Cure on Day 7Not Cured47 Participants
Comparison: Comparison between the treatment and placebop-value: 0.842695% CI: [-18.5, 10.5]Cochran-Mantel-Haenszel
Post Hoc

Absolute Difference Clinical Cure at Day 14 and 21 for Study 1

Difference in percentage of clinical cure rates between the two treatment groups

Time frame: Up to Day 21

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AR-105Absolute Difference Clinical Cure at Day 14 and 21 for Study 1Cured Day 146 Participants
AR-105Absolute Difference Clinical Cure at Day 14 and 21 for Study 1Cured Day 217 Participants
ControlAbsolute Difference Clinical Cure at Day 14 and 21 for Study 1Cured Day 148 Participants
ControlAbsolute Difference Clinical Cure at Day 14 and 21 for Study 1Cured Day 2110 Participants
Comparison: Data for Day 14p-value: 0.461695% CI: [-16.2, 60.6]Chi-squared
Comparison: Data for Day 21p-value: 0.405395% CI: [-13.3, 57.8]Chi-squared
Post Hoc

Absolute Difference Clinical Cure at Day 14 and 21 for Study 2

Difference in percentage of clinical cure rates between the two treatment groups

Time frame: Up to Day 21

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AR-105Absolute Difference Clinical Cure at Day 14 and 21 for Study 2Cured Day 142 Participants
AR-105Absolute Difference Clinical Cure at Day 14 and 21 for Study 2Cured Day 212 Participants
ControlAbsolute Difference Clinical Cure at Day 14 and 21 for Study 2Cured Day 142 Participants
ControlAbsolute Difference Clinical Cure at Day 14 and 21 for Study 2Cured Day 213 Participants
Comparison: Data for Day 14p-value: 0.083390% CI: [-14.8, 90.9]Chi-squared
Comparison: Data for Day 21p-value: 0.515190% CI: [-30.5, 78.1]Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026