A Phase 2 interventional study of AR-105 and Placebo in Pseudomonas Aeruginosa Pneumonia, sponsored by Aridis Pharmaceuticals, Inc.. Completed at 111 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by Aridis Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 158 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Aridis Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria (main criteria):
One intravenous infusion of AR-105 20mg/'kg
Drug: AR-105
Matching placebo
Drug: Placebo
monoclonal antibody
Also known as: Aerubumab, Aerucin
matching placebo (+ SOC antibiotics)
Also known as: Control (SOC antibiotics)
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
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
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
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
| Milestone | AR-105 | Control |
|---|---|---|
| Started | 79 | 79 |
| Completed | 49 | 62 |
| Not completed | 30 | 17 |
A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group
| Participants | AR-105 | Control |
|---|---|---|
| Observed Cured | 34 | 37 |
| Imputed Cured | 6 | 5 |
| Not Cured | 25 | 20 |
| Reinfection same pathogen | 5 | 2 |
| New Infection Different Pathogen | 0 | 3 |
| New infection Unknown pathogen | 0 | 0 |
A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group
| Participants | AR-105 | Control |
|---|---|---|
| Cured Observed | 16 | 18 |
| Cured Imputed | 0 | 0 |
| Not Cured | 52 | 47 |
| Re-infection Same Pathogen | 1 | 0 |
| New Infection Different Pathogen | 1 | 1 |
| New Infection Unknown Pathogen | 0 | 1 |
A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group
| Participants | AR-105 | Control |
|---|---|---|
| Observed Cured | 36 | 31 |
| Imputed Cured | 1 | 2 |
| Not Cured | 29 | 30 |
| Reinfection same pathogen | 1 | 0 |
| New Infection Different Pathogen | 2 | 4 |
| New infection Unknown Pathogen | 1 | 0 |
A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group
| Participants | AR-105 | Control |
|---|---|---|
| Observed Cured | 35 | 38 |
| Imputed Cured | 9 | 6 |
| Not Cured | 23 | 16 |
| Reinfection same pathogen | 3 | 3 |
| New Infection Different Pathogen | 0 | 4 |
| New infection Unknown Pathogen | 0 | 0 |
Difference in percentage of clinical cure rates between the two treatment groups
| Participants | Subset AR-105 Study1 | Subset Placebo Study1 |
|---|---|---|
| Cured Day 14 | 6 | 8 |
| Cured Day 21 | 7 | 10 |
Difference in percentage of clinical cure rates between the two treatment groups
| Participants | Subset AR-105 Study2 | Subset Placebo Study2 |
|---|---|---|
| Cured Day 14 | 2 | 2 |
| Cured Day 21 | 2 | 3 |
Collected over 1 month: from administration day (Day 0) up to Day 28 (28 days after administration). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AR-105 | 25/79 (31.6%) | 36/79 (45.6%) | 73/79 (92.4%) |
| Control | 13/79 (16.5%) | 22/79 (27.8%) | 73/79 (92.4%) |
| Event | AR-105 | Control |
|---|---|---|
| Multiple organ dysfunction syndromeGeneral disorders | 7/79 | 4/79 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 5/79 | 0/79 |
| Septic shockInfections and infestations | 5/79 | 3/79 |
| Brain herniationInjury, poisoning and procedural complications | 3/79 | 0/79 |
| Cardiac failure acuteCardiac disorders | 3/79 | 1/79 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 3/79 | 2/79 |
| Brain oedemaNervous system disorders | 3/79 | 0/79 |
| PneumoniaInfections and infestations | 3/79 | 1/79 |
| SepsisInfections and infestations | 3/79 | 0/79 |
| Cardiac arrestCardiac disorders | 2/79 | 1/79 |
| Event | AR-105 | Control |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 16/79 | 13/79 |
| HypotensionVascular disorders | 14/79 | 9/79 |
| DiarrhoeaGastrointestinal disorders | 5/79 | 13/79 |
| HypokalaemiaMetabolism and nutrition disorders | 12/79 | 6/79 |
| Multiple organ dysfunction syndromeGeneral disorders | 10/79 | 4/79 |
| Decubitus ulcerSkin and subcutaneous tissue disorders | 6/79 | 9/79 |
| Atrial fibrillationCardiac disorders | 6/79 | 7/79 |
| Alanine aminotransferase increasedInvestigations | 0/79 | 6/79 |
| Aspartate aminotransferase increasedInvestigations | 0/79 | 6/79 |
| ThrombocytopeniaBlood and lymphatic system disorders | 6/79 | 1/79 |
| Age, Continuous(years) | AR-105 | Control | Total |
|---|---|---|---|
| Mean | 63.5 ± 13.83 | 61.2 ± 15.58 | 62.3 ± 14.73 |
| Age, Customized(Participants) | AR-105 | Control | Total |
|---|---|---|---|
| Age </= 64 years | 40 | 39 | 79 |
| Age > 64 years | 39 | 40 | 79 |
| Sex: Female, Male(Participants) | AR-105 | Control | Total |
|---|---|---|---|
| Female | 17 | 21 | 38 |
| Male | 62 | 58 | 120 |
| Race (NIH/OMB)(Participants) | AR-105 | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 4 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 73 | 74 | 147 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | AR-105 | Control | Total |
|---|---|---|---|
| Hungary | 10 | 8 | 18 |
| United States | 3 | 4 | 7 |
| Czechia | 5 | 5 | 10 |
| Ukraine | 6 | 11 | 17 |
| Belarus | 7 | 5 | 12 |
| Russia | 21 | 21 | 42 |
| Spain | 4 | 3 | 7 |
| Greece | 5 | 2 | 7 |
| Belgium | 3 | 3 | 6 |
| Taiwan | 2 | 3 | 5 |
| Georgia | 1 | 0 | 1 |
| France | 10 | 14 | 24 |
| South Korea | 2 | 0 | 2 |
| World Regions(Participants) | AR-105 | Control | Total |
|---|---|---|---|
| Americas | 3 | 4 | 7 |
| Eastern Europe | 50 | 50 | 100 |
| Western Europe | 22 | 22 | 44 |
| Asia | 4 | 3 | 7 |
Showing the first 100 of 111 sites across 17 countries.
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Aridis Pharmaceuticals, Inc.