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

Phase 2

Completed

• Conditions: Pseudomonas Aeruginosa Pneumonia
• Interventions: Drug: AR-105; Drug: Placebo

• Registration Number: NCT03027609
• Lead Sponsor: Aridis Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-23
• Study Start: 2017-03-29
• Primary Completion: 2019-04-25
• Study Completion: 2019-04-25
• Status Verified: 2019-08
• Results First Submitted: 2021-10-06
• Results First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-03-08
• Results First Posted: 2022-03-09
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AR-105	AR-105	One intravenous infusion of AR-105 20mg/'kg
Control	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
Clinical Cure on Day 21	21 days following dosing	A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group

Secondary Outcome Measures

Name	Time	Method
Clinical Cure on Day 7	7 days following dosing	A 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 14	14 days following dosing	A 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 28	28 days following dosing	A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group

Trial Locations

Locations (11)

Research Site 5; 🇺🇸 Chicago, Illinois, United States

Research Site 9; 🇺🇸 Royal Oak, Michigan, United States

Research Site 2; 🇨🇳 Taipei, Taiwan

Research Site 10; 🇺🇸 Saint Louis, Missouri, United States

Research Site 4; 🇨🇳 Taipei, Taiwan

Research Site 6; 🇺🇸 Lexington, Kentucky, United States

Research Site 3; 🇨🇳 Taipei, Taiwan

Research Site 1; 🇨🇳 Taipei, Taiwan

Research Site 7; 🇺🇸 Detroit, Michigan, United States

Research Site 8; 🇺🇸 Detroit, Michigan, United States

Research Site; 🇺🇦 Lviv, Ukraine