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Clinical Trials List

Protocol NumberAR-301-002
NCT Number(ClinicalTrials.gov Identfier)NCT03816956

2020-01-03 - 2021-03-08

Phase III

Not yet recruiting9

Recruiting1

ICD-10J15.20

Pneumonia due to staphylococcus, unspecified

ICD-9482.40

Pneumonia due to Staphylococcus, unspecified

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Efficacy and Safety of AR-301 as Adjunct Therapy to Antibiotics in the Treatment of Ventilator-associated Pneumonia (VAP) Caused by S. aureus

  • Trial Applicant

    PROTECH PHARMASERVICES CORPORATION

  • Sponsor

    Aridis Pharmaceuticals, Inc./Shenzhen Arimab Biopharmaceuticals Co., Ltd

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 陳垚生 Division of Infectious Disease
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yu-Chao Lin Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Jia-Yih Feng Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shu-Min Lin Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 王甯祺 Division of Infectious Disease
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming -Cheng Chan Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 邱銘煌 Division of Thoracic Medicine
Cathay General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chong-Jen Yu Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chun-Liang Chou Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

AR-301 as Adjunct Therapy to Antibiotics in the Treatment of Ventilator-associated Pneumonia (VAP) Caused by S. aureus

Objectives

Primary Clinical Efficacy Objective To assess the difference in Clinical Cure rates between SOC alone and SOC with AR-301 at Day 21. Stringent Clinical Cure criteria have been defined in collaboration with clinical experts in the field. Secondary Clinical Efficacy Objectives To assess the difference in the following clinical outcomes between SOC alone and SOC with AR-301: 1. Clinical Cure rates at Day 7, 14 and 28, using the same criteria as for the primary efficacy objective at Day 21. 2. Time to Clinical Cure. 3. Mortality: All-cause mortality, Pneumonia-related mortality. 4. Respiratory functional assessment: Time on mechanical ventilation (including if tracheostomy is in place). Time on supplemental oxygenation. Measures of respiratory health such as changes in PaO2/FiO2, using arterial blood gases (ABG) and/or pulse oximetry measurements. 5. Overall clinical status: Changes in Sequential Organ Failure Assessment (SOFA) score. Primary Clinical Safety Objective To assess the clinical safety and tolerability of AR-301 in the study population. Secondary Clinical Safety Objective To assess the immunogenicity of AR-301. Secondary Clinical Efficacy Objectives To assess the difference in the following clinical outcomes between SOC alone and SOC with AR-301: 1. Clinical Cure rates at Day 7, 14 and 28, using the same criteria as for the primary efficacy objective at Day 21. 2. Time to Clinical Cure 3. Mortality: All-cause mortality, Pneumonia-related mortality 4. Respiratory functional assessment: Time on mechanical ventilation (including if tracheostomy is in place). Time on supplemental oxygenation. Measures of respiratory health such as changes in PaO2/FiO2, using arterial blood gases (ABG) and/or pulse oximetry measurements. 5. Overall clinical status: Changes in Sequential Organ Failure Assessment (SOFA) score.

Test Drug

AR-301 Tosatoxumab

Active Ingredient

Tosatoxumab

Dosage Form

IVT

Dosage

25 mg/mL

Endpoints

Primary Outcome Measures :
A comparison of Clinical Cure Rates of standard of care (SOC) alone and SOC with AR-301 [ Time Frame: 21 days ]
Clinical cure rates of standard of care (SOC) alone and (SOC) with AR-301 at Day 21 as measured by all-cause mortality, need for mechanical ventilation and signs and symptoms of pneumonia.

Safety of AR-301 by treatment-emergent adverse events assessed by changes between treatment and placebo as assessed by the Principal Investigator [ Time Frame: 21 Days ]
Safety of AR-301 of treatment-emergent adverse events as assessed by changes assessed by the PI between treatment and placebo

Tolerability of AR-301 measured by the number of participants with treatment-emergent adverse events classified using CTCAE v 5.0 [ Time Frame: 21 Days ]
Tolerability of AR-301 will be measured and evaluated by the severity of treatment-emergent adverse events using the CTCAE v 5.0.

Secondary Outcome Measures :
The difference in clinical cure rates between Standard of Care alone or with AR301 as time to clinical cure at Day 7, 14 and 28 [ Time Frame: Day 7, 14, and 28 ]
Difference in Clinical Cure rates between SOC alone or with AR-301 defined by time to clinical cure (number of days) using the same criteria as for the primary efficacy objective at Day 21.

The difference in mortality between Standard of Care alone or with AR-301 at Days 7,14,28 [ Time Frame: Day 7, 14, and 28 ]
Difference in mortality defined as cause of death (all-cause mortality and pneumonia-related mortality)between SOC alone or with AR-301 at Days 7,14, and 28

The difference in PaO2/FiO2 between Standard of Care alone or with AR-301 at Days 7,14,28 [ Time Frame: Day 7, 14, and 28 ]
Difference in respiratory function between SOC alone or with AR-301 at Days 7,14, and 28 as changes in PaO2/FiO2 ratio (e.g. by arterial blood gases), if available and whenever possible OR changes in non-invasive measures of oxygenation (e.g. by pulse oximetry)

The difference in time on supplemental oxygen assessment between Standard of Care alone or with AR-301 at Days 7,14,28 [ Time Frame: Day 7, 14, and 28 ]
Difference in respiratory function between SOC alone or with AR-301 at Days 7,14, and 28 as time on supplemental oxygen

Changes in baseline in SOFA score between Standard of Care alone or with AR301 at Days 7,14,28 [ Time Frame: Day 7, 14, and 28 ]
Difference in Clinical Cure rates between SOC alone or with AR-301 at Days 7,14, and 28 in the following clinical outcomes:

Changes from Baseline in sequential organ failure assessment (SOFA) score using the following scale: Maximum SOFA score 0-6, <10% Mortality, 7-9 15-20% mortality, 10-12 40-50% mortality, 13-14 50-60% mortality, 15 >80% mortality, 15-24 >90% mortality. Lower numbers are considered to be better outcome of mortality and higher scores worse outcome of mortality.


Duration of intubation with ventilation [ Time Frame: 28 days ]
Number of days with intubation with ventilation

Duration mechanical ventilation if tracheostomy in place [ Time Frame: 28 days ]
Number of days of intubation with mechanical ventilation if tracheostomy in place

Duration of stay in ICU [ Time Frame: 28 days ]
Number of days of stay in ICU

Duration hospitalization [ Time Frame: 28 days ]
Number of days of hospitalization

Duration antibiotic use. [ Time Frame: 28 days ]
Number of days on antibiotics

Pharmacokinetic Analysis - (Cmax) [ Time Frame: 28 days ]
Pharmacokinetic analysis measuring Maximum Serum Concentration (Cmax)

Pharmacokinetic Analysis - (AUC) [ Time Frame: 28 Days ]
Pharmacokinetic analysis measuring Area Under the Curve (AUC)

Pharmacokinetic Analysis - (T1/2) [ Time Frame: 28 Days ]
Pharmacokinetic analysis measuring time for half of the initial dose of study drug to be eliminated from the body (T1/2)

Pharmacokinetic Analysis - (Tmax) [ Time Frame: 28 Days ]
Pharmacokinetic analysis measuring time at which Cmax is obtained (Tmax)

Pharmacokinetic Analysis (Blood levels of AR-301) [ Time Frame: 28 Days ]
Blood levels of AR-301 in the patient over time during the study period.

Inclution Criteria

Inclusion Criteria:

Written Informed Consent given by the patient or, if not possible, by a legally acceptable representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
To be at least 18 years of age. Taiwan only: To be at least 20 years of age. South Korea only: To be at least 19 years of age.
Treated in an ICU at the time of enrollment.
Endotracheal tube in place (tracheostomy is allowed).
The patient is mechanically ventilated for at least 48 hours.
Diagnosis of pneumonia based on the following criteria (a, b, and c, all must be met):

One definitive chest X-ray diagnostic of pneumonia within 48 hours,
Hypoxemia based on PaO2/FiO2.
At least one of the following signs:
i. Documented fever (e.g., body temperature greater than or equal to 38º Celsius).

ii. Hypothermia (e.g., core body temperature less than or equal to 35º Celsius).

iii. Total peripheral white blood cell (WBC) count greater than or equal to 10,000 cells/µL (or mm3).

iv. Leukopenia with total WBC less than or equal to 4,500 cells/µL (mm3). v. Greater than 15 percent immature neutrophils (bands) noted on peripheral blood smear.

Documented pulmonary infection with Staphylococcus aureus obtained by bronchoalveolar lavage (BAL), mini-BAL, protected endotracheal aspiration/aspirate (ETA) (collectively 'airway specimen').

Exclusion Criteria

Exclusion Criteria

The subject is unlikely to survive for the study duration despite delivery of adequate antibiotics and supportive care for treatment of S. aureus pneumonia.
Effective antibacterial drug therapy for the index pneumonia administered continuously for 48 hours or more prior to initiation of study treatment. Effective antibiotics would include those typically used to treat S. aureus.
Plasmapheresis (ongoing or planned), extracorporeal membrane oxygenation (ECMO) or any procedure that would remove/filter out the monoclonal antibody/study drug.
Immunocompromised patients.
Known hereditary complement deficiency.
Liver dysfunction with a Child Pugh C score > 9 (Child Pugh score of A or B are acceptable at discretion of the Principal Investigator [PI]).
Pulmonary disease that precludes evaluation of a therapeutic response (such as lung cancer resulting in bronchial obstruction or on the same side as the pneumonia, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection, lung abscess, pleural empyema or post obstructive pneumonia).
Patient has received intravenous (IV) immunoglobulin therapy within 3 months prior to the Screening Visit.
Any woman of child-bearing potential (WOCBP) who does not have a negative pregnancy test result at Screening using SERUM or URINE testing based on Beta-subunit human chorionic gonadotropin (HCG) standard tests and methods from the local laboratory.
Any sexually active subject who is unwilling to use acceptable methods of contraception for 120 days after dosing.
Known lack of treatment compliance from prior studies or ongoing medical care based on medical records and PI's judgment and/or the capacity of the patient to comply with all study requirements.
Any medical, psychological, cognitive, social or legal conditions that would interfere in the ability to give an Informed Consent OR the absence of a legally valid representative of the patient or independent physician allowed and able to give consent on his/her behalf.
Participation as a subject in another interventional study within 30 days prior to the first dose of study treatment, or planned participation in such a study during the study or within 30 days of its completion by the patient.

The Estimated Number of Participants

  • Taiwan

    31 participants

  • Global

    240 participants

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