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

NCT03027609 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AR-105-002
• Study Type: interventional
• Target: 158
• Locations: 16 countries
• Sites: 105

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.

Conditions

Pseudomonas Aeruginosa Pneumonia

Keywords

Pseudomonas aeruginosa; pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

  21 days following dosing

Secondary Outcomes (3)

• Clinical Cure on Day 7

  7 days following dosing

• Clinical Cure on Day 14

  14 days following dosing

• Clinical Cure on Day 28

  28 days following dosing

Study Arms (2)

AR-105

EXPERIMENTAL

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

Drug: AR-105

Control

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

AR-105 DRUG

monoclonal antibody

Also known as: Aerubumab, Aerucin

AR-105

Placebo DRUG

matching placebo (+ SOC antibiotics)

Also known as: Control (SOC antibiotics)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• being moribund
• effective antibiotic therapy ≥48 hours
• immunocompromised
• underlying pulmonary disease that may preclude the assessment of a therapeutic response

Sponsors & Collaborators

• Aridis Pharmaceuticals, Inc.: lead

Study Sites (111)

Research Site 1

Sacramento, California, 95814, United States

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Research Site 2

San Diego, California, 92103, United States

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Research Site 3

Jacksonville, Florida, 32209, United States

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Research Site 4

Tampa, Florida, 33606, United States

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Research Site 5

Chicago, Illinois, 60611, United States

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Research Site 6

Lexington, Kentucky, 40536, United States

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Research Site 7

Detroit, Michigan, 48201, United States

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Research Site 8

Detroit, Michigan, 48201, United States

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Research Site 9

Royal Oak, Michigan, 48073, United States

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Research Site 10

St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63141, United States

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Hackensack, New Jersey, 02601, United States

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Durham, North Carolina, 27710, United States

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Columbus, Ohio, 43215, United States

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Adelaide, 5000, Australia

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Woolloongabba, QLD 4102, Australia

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Brest, 224027, Belarus

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Grodno, 230030, Belarus

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Homyel, 246027, Belarus

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Minsk, 220049, Belarus

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Minsk, 223041, Belarus

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Vitebsk, 210037, Belarus

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Brussels, 1090, Belgium

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Brussels, 11070, Belgium

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Brussels, 1200, Belgium

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Dinant, 5500, Belgium

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Liège, 4000, Belgium

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Yvoir, 5530, Belgium

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Brno, 65691, Czechia

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Pilsen, 30460, Czechia

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Prague, 10034, Czechia

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Prague, 12808, Czechia

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Prague, 16902, Czechia

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Teplice, 41529, Czechia

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Zlín, 76275, Czechia

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Angers, 49933, France

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Argenteuil, 95107, France

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Colombes, 92701, France

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La Roche-sur-Yon, 85925, France

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Le Chesnay, 78157, France

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Lille, 59037, France

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Limoges, 87042, France

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Lyon, 69004, France

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Lyon, 69677, France

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Nantes, 44093, France

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Paris, 75013, France

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Research Site 2

Paris, 75013, France

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Paris, 75013, France

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Pierre-Bénite, 69495, France

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Pontoise, 95303, France

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Strasbourg, 67091, France

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Tourcoing, 59208, France

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Tours, 37044, France

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Kutaisi, 4600, Georgia

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Kutaisi, 4600, Georgia

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Tbilisi, 0144, Georgia

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Athens, 10676, Greece

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Athens, 11527, Greece

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Larissa, 41110, Greece

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Larissa, 41221, Greece

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Budapest, 1122, Hungary

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Budapest, H-1082, Hungary

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Budapest, H-1134, Hungary

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Debrecen, H-4032, Hungary

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Nyíregyháza, H-4400, Hungary

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Guadalajara, 44280, Mexico

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Guadalajara, 44760, Mexico

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Monterrey, 64460, Mexico

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Lima, 15072, Peru

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Miraflores, 15074, Peru

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San Martín de Porres, 15102, Peru

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Opole, 45-418, Poland

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Warsaw, 02-781, Poland

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Krasnodar, 350012, Russia

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Krasnoyarsk, 660022, Russia

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Novosibirsk, 119049, Russia

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Novosibirsk, 630051, Russia

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Novosibirsk, 630075, Russia

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Saint Petersburg, 192242, Russia

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Saint Petersburg, 196067, Russia

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Saint Petersburg, 196247, Russia

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Saint Petersburg, 197706, Russia

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Tomsk, 634050, Russia

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Gyeonggi-do, 425-707, South Korea

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Research Site 2

Gyeonggi-do, 442-723, South Korea

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Seoul, 02841, South Korea

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Research Site 1

Seoul, 03080, South Korea

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Research Site 3

Seoul, 05505, South Korea

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Research Site 4

Seoul, 07441, South Korea

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Wŏnju, 26426, South Korea

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Barcelona, 08036, Spain

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Research Site 2

Barcelona, 08221, Spain

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Research Site 3

Barcelona, 08221, Spain

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Barcelona, 0897, Spain

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Madrid, 28040, Spain

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Mataró, 08034, Spain

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Oviedo, 33011, Spain

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Santander, 39008, Spain

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Tarragona, 43005, Spain

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Kaohsiung City, 80756, Taiwan

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Research Site 2

Kaohsiung City, 81362, Taiwan

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Research Site 2

Taichung, 40447, Taiwan

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Taichung, 40705, Taiwan

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Tainan, 71004, Taiwan

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Taipei, 10002 R.O.C, Taiwan

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Research Site 4

Taipei, 10449, Taiwan

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Research Site 2

Taipei, 11217, Taiwan

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Research Site 3

Taipei, 114, Taiwan

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Ivano-Frankivsk, 76008, Ukraine

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Kiev, 01034, Ukraine

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Lviv, 79059, Ukraine

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MeSH Terms

Conditions

Pseudomonas Infections; Pneumonia

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

A post-hoc analysis was performed on the data reviewed by the AC, using the appropriate clinical severity, adequate antibiotic criteria and the inflammatory status of the patient (level of C-reactive protein \[CRP\]).

Results Point of Contact

• Title: Lynne Deans
• Organization: Aridis Pharmaceutical Inc

deansl@aridispharma.com

001-925200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 23, 2017
• Study Start: March 29, 2017
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: March 17, 2022
• Results First Posted: March 9, 2022

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7); ME (3); PL (2); GR (4); PE (3); US (14); BE (6); UA (3); TW (9); AU (2); HU (5); GE (3); RU (10); CZ (7); FR (18); ES (9)