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

Aridis Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Pseudomonas Aeruginosa Pneumonia

Treatments: Drug: Placebo; Drug: AR-105

Study type: Interventional

Funder types: Industry

Identifiers

NCT03027609

AR-105-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups, including a placebo group

AR-105

Experimental group

Description:

One intravenous infusion of AR-105 20mg/'kg

Treatment:

Drug: AR-105

Control

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo