Prosthetic Joint InfectionPhase 1NCT04763759
Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections
A Phase 1 study testing TRL1068, a human monoclonal antibody in people with Prosthetic Joint Infection, run by Trellis Bioscience LLC at 9 sites in United States.
Trial summary
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- TRL1068, a human monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 9 sitesUnited States
- Study dates
- 8 Feb 2021to 13 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PJI of the knee or hip
- Identified pathogen(s) must be susceptible to antibiotic regimen
- Planned/scheduled for primary two-stage exchange arthroplasty
- BMI < 40 kg/m²
- Willing and able to provide written informed consent
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
- Men and women of child bearing potential (WOCBP) must be willing to practice a highly effective method of contraception
Who cannot join
- Evidence of active infection other than bacterial PJI of the knee or hip
- Inability to receive or intolerant to pathogen-appropriate systemic or oral antibiotic therapy
- Chronic obstructive pulmonary disease (COPD)
- Child-Pugh score > 6
- Congestive heart failure
- Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids
Show all 18Show fewer
- Active malignancy, or history of malignancy or chemotherapy within the past 2 years
- Active or history of autoimmune disease
- Uncontrolled diabetes, defined as hemoglobin A1c > 7.4%
- Clinically significant abnormality on electrocardiogram (ECG) that would preclude subject from undergoing two-stage exchange arthroplasty
- Clinically significant serum chemistry or hematology abnormalities
- Any acute illness within 14 days of Day 1 that could confound the evaluation of safety evaluation
- Known or suspected intolerance or hypersensitivity to any biologic medication
- Received a therapeutic antibody or biologic within the 6 months prior to Screening
- Positive serum test for pregnancy, pregnant, or nursing women
- Positive reverse transcription polymerase chain reaction (RT -PCR) or alternative (antigen) test for acute respiratory syndrome coronavirus 2
- History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the subject's ability to comply with the study requirements
- Any other comorbidity or condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
University of Alabama
Birmingham, Alabama, 35205
University of Virginia
Charlottesville, Virginia, 22903
University of Florida
Gainesville, Florida, 32611
Houston Methodist Research Institute
Houston, Texas, 77030
USC
Los Angeles, California, 90033
UCLA
Santa Monica, California, 90404
Gulfcoast Research Institute
Sarasota, Florida, 34232
Phoenix Clinical Research
Tamarac, Florida, 33321
About this study
Official title: A Phase 1, Blinded, Single Ascending Dose Study to Evaluate Safety, Pharmacokinetics, and Activity of TRL1068 in Subjects With Prosthetic Joint Infection of the Knee or Hip, Undergoing Primary Two Stage Exchange Arthroplasty
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.
Read the detailed description
Approximately 75% of all clinically significant human infections are estimated to be biofilm-related. Prosthetic joint infections are a classical example of difficult to eradicate infections associated with biofilm. Most Prosthetic Joint Infection (PJI) cases are caused by staphylococcal species (~70%) with an increasing number being antibiotic-resistant (MRSA). In the US, two-stage revision is the standard of care for replacement of an infected prosthetic joint, and is associated with substantial costs and prolonged immobility. TRL1068 is a fully human antibody that has been shown in pre-clinical studies to disrupt biofilm. TRL1068 targets a highly conserved epitope on the DNABII family of bacterial DNA binding proteins that includes histone-like (HU) and integration host factor (IHF) proteins of clinically relevant Gram-positive and Gram-negative bacteria. The DNABII epitope bound by TRL1068 has no homologs in the human proteome.
- Conditions
- Prosthetic Joint Infection
- Being tested
- TRL1068, a human monoclonal antibody
- Keywords
- biofilm, antibiotic-resistant infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRL1068, a human monoclonal antibodyDrug
A human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1- 6mg/kg | Experimental | Randomized 3:1 (TRL1068:placebo) via IV infusion Receives: Drug: TRL1068, a human monoclonal antibody |
| Dose Level 2- 15mg/kg | Experimental | Randomized 5:2 (TRL1068:placebo) via IV infusion Receives: Drug: TRL1068, a human monoclonal antibody |
| Dose Level 3- 30 mg/kg | Experimental | Randomized 5:2 (TRL1068:placebo) via IV infusion Receives: Drug: TRL1068, a human monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Abnormal Physical Examination Findings
clinically significant abnormal physical exam findings will be reviewed
Measured: 16 weeks
Incidence of Abnormal Serum Chemistries and Hematology
clinically significant abnormal laboratory results will be reviewed
Measured: 16 weeks
Incidence of Abnormal Vital Signs (Temperature)
clinically significant abnormal temperatures will be reviewed
Measured: 16 weeks
Incidence of Abnormal Vital Signs (Blood Pressure)
clinically significant abnormal blood pressures will be reviewed
Measured: 16 weeks
Incidence of Abnormal Vital Signs (Heart Rate)
clinically significant abnormal heart rates will be reviewed
Measured: 16 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
mortality and any other reported AEs and SAEs will be reviewed
Measured: 24 weeks
Secondary outcomes (10)
Characterize the pharmacokinetics (PK) of a single IV infusion of TRL1068
Serum and synovial concentrations of TRL1068 will be determined by ELISA
Measured: 16 weeks
Measure TRL1068 levels in synovial fluid on Day 8 and compare with plasma PK
Serum and synovial concentrations of TRL1068 will be determined by ELISA
Measured: 1 week
Assess the pharmacodynamics (PD) of TRL1068 (Colony Forming Units (CFUs) prosthesis)
Number of CFUs from sonicated prosthetic device
Measured: 1 week
Assess the pharmacodynamics (PD) of TRL1068 (CFUs spacer)
Number of CFUs from sonicated orthopedic spacer
Measured: 12 weeks
Assess the pharmacodynamics (PD) of TRL1068 (CRP)
Inflammatory biomarker CRP
Measured: 16 weeks
Assess the pharmacodynamics (PD) of TRL1068 (ESR)
Inflammatory biomarker ESR
Measured: 16 weeks
Assess the pharmacodynamics (PD) of TRL1068 (IL-6)
Inflammatory biomarker IL-6
Measured: 16 weeks
Assess the pharmacodynamics (PD) of TRL1068 (IL-10)
Inflammatory biomarker IL-10
Measured: 16 weeks
Assess the pharmacodynamics (PD) of TRL1068 (reinfection)
Assessment for reinfection including need for further surgical interventions and overall outcome
Measured: 24 weeks
Assess the immunogenicity of TRL1068 as measured by anti-drug antibodies (ADAs)
Anti-drug antibodies (ADA), i.e. anti-TRL1068 antibodies in serum will determined by electrochemiluminescence assay.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start8 Feb 2021
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1, Double-Blinded, Single Ascending Dose Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trellis Bioscience LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, Biomedical Advanced Research and Development Authority, Wellcome Trust, Sinai Hospital of Baltimore, Gulfcoast Research Institute, Phoenix Clinical Research, University of Florida, University of Alabama at Birmingham, The Methodist Hospital Research Institute, University of Virginia, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Nicholas Bernthal, MD, Principal investigator, University of California, Los AngelesJanet Conway, MD, Principal investigator, Sinai Hospital of BaltimoreEdward Stolarski, MD, Principal investigator, Gulfcoast Research InstituteRichard Berkowitz, MD, Principal investigator, Phoenix Clinical ResearchLuis Pulido, MD, Principal investigator, University of FloridaSameer Naranje, MD, Principal investigator, University of Alabama at BirminghamStephen Incavo, MD, Principal investigator, The Methodist Hospital Research InstituteIan Duensing, MD, Principal investigator, UVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763759
- Sponsor's protocol ID
- TRL1068-101
- Status last verified
- Nov 2024
- First submitted
- 12 Feb 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The study results have been published.
Publications
Estelles A, Woischnig AK, Liu K, Stephenson R, Lomongsod E, Nguyen D, Zhang J, Heidecker M, Yang Y, Simon RJ, Tenorio E, Ellsworth S, Leighton A, Ryser S, Gremmelmaier NK, Kauvar LM. A High-Affinity Native Human Antibody Disrupts Biofilm from Staphylococcus aureus Bacteria and Potentiates Antibiotic Efficacy in a Mouse Implant Infection Model. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2292-301. doi: 10.1128/AAC.02588-15. Print 2016 Apr.
PubMed 26833157Xiong YQ, Estelles A, Li L, Abdelhady W, Gonzales R, Bayer AS, Tenorio E, Leighton A, Ryser S, Kauvar LM. A Human Biofilm-Disrupting Monoclonal Antibody Potentiates Antibiotic Efficacy in Rodent Models of both Staphylococcus aureus and Acinetobacter baumannii Infections. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00904-17. doi: 10.1128/AAC.00904-17. Print 2017 Oct.
PubMed 28717038Conway J, Delanois RE, Mont MA, Stavrakis A, McPherson E, Stolarski E, Incavo S, Oakes D, Salvagno R, Adams JS, Kisch-Hancock A, Tenorio E, Leighton A, Ryser S, Kauvar LM, Bernthal NM. Phase 1 study of the pharmacokinetics and clinical proof-of-concept activity of a biofilm-disrupting human monoclonal antibody in patients with chronic prosthetic joint infection of the knee or hip. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0065524. doi: 10.1128/aac.00655-24. Epub 2024 Jul 16.
PubMed 39012102
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Blinded, Single Ascending Dose Study to Evaluate Safety, Pharmacokinetics, and Activity of TRL1068 in Subjects With Prosthetic Joint Infection of the Knee or Hip, Undergoing Primary Two Stage Exchange Arthroplasty
- ClinicalTrials.gov ID
- NCT04763759
- Acronym / sponsor ID
- TRL1068-101
- Conditions
- Prosthetic Joint Infection
- Keywords
- biofilm, antibiotic-resistant infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Trellis Bioscience LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, Biomedical Advanced Research and Development Authority, Wellcome Trust, Sinai Hospital of Baltimore, Gulfcoast Research Institute, Phoenix Clinical Research, University of Florida, University of Alabama at Birmingham, The Methodist Hospital Research Institute, University of Virginia, University of Southern California
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.
Detailed description
Approximately 75% of all clinically significant human infections are estimated to be biofilm-related. Prosthetic joint infections are a classical example of difficult to eradicate infections associated with biofilm. Most Prosthetic Joint Infection (PJI) cases are caused by staphylococcal species (~70%) with an increasing number being antibiotic-resistant (MRSA). In the US, two-stage revision is the standard of care for replacement of an infected prosthetic joint, and is associated with substantial costs and prolonged immobility. TRL1068 is a fully human antibody that has been shown in pre-clinical studies to disrupt biofilm. TRL1068 targets a highly conserved epitope on the DNABII family of bacterial DNA binding proteins that includes histone-like (HU) and integration host factor (IHF) proteins of clinically relevant Gram-positive and Gram-negative bacteria. The DNABII epitope bound by TRL1068 has no homologs in the human proteome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase 1, Double-Blinded, Single Ascending Dose Study
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1- 6mg/kg | Experimental | Drug: TRL1068, a human monoclonal antibodyRandomized 3:1 (TRL1068:placebo) via IV infusion |
| Dose Level 2- 15mg/kg | Experimental | Drug: TRL1068, a human monoclonal antibodyRandomized 5:2 (TRL1068:placebo) via IV infusion |
| Dose Level 3- 30 mg/kg | Experimental | Drug: TRL1068, a human monoclonal antibodyRandomized 5:2 (TRL1068:placebo) via IV infusion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of PJI of the knee or hip
- Identified pathogen(s) must be susceptible to antibiotic regimen
- Planned/scheduled for primary two-stage exchange arthroplasty
- BMI < 40 kg/m²
- Willing and able to provide written informed consent
Key exclusion criteria (18 listed)
- Evidence of active infection other than bacterial PJI of the knee or hip
- Inability to receive or intolerant to pathogen-appropriate systemic or oral antibiotic therapy
- Chronic obstructive pulmonary disease (COPD)
- Child-Pugh score > 6
- Congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRL1068, a human monoclonal antibodyA human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody | Drug | Dose Level 1- 6mg/kg, Dose Level 2- 15mg/kg, Dose Level 3- 30 mg/kg |
Primary outcome
Incidence of Abnormal Physical Examination Findings
Time frame: 16 weeks
clinically significant abnormal physical exam findings will be reviewed
Incidence of Abnormal Serum Chemistries and Hematology
Time frame: 16 weeks
clinically significant abnormal laboratory results will be reviewed
Incidence of Abnormal Vital Signs (Temperature)
Time frame: 16 weeks
clinically significant abnormal temperatures will be reviewed
Incidence of Abnormal Vital Signs (Blood Pressure)
Time frame: 16 weeks
clinically significant abnormal blood pressures will be reviewed
Incidence of Abnormal Vital Signs (Heart Rate)
Time frame: 16 weeks
clinically significant abnormal heart rates will be reviewed
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 24 weeks
mortality and any other reported AEs and SAEs will be reviewed
10 secondary outcomes
Characterize the pharmacokinetics (PK) of a single IV infusion of TRL1068
Time frame: 16 weeks
Measure TRL1068 levels in synovial fluid on Day 8 and compare with plasma PK
Time frame: 1 week
Assess the pharmacodynamics (PD) of TRL1068 (Colony Forming Units (CFUs) prosthesis)
Time frame: 1 week
Assess the pharmacodynamics (PD) of TRL1068 (CFUs spacer)
Time frame: 12 weeks
Assess the pharmacodynamics (PD) of TRL1068 (CRP)
Time frame: 16 weeks
Assess the pharmacodynamics (PD) of TRL1068 (ESR)
Time frame: 16 weeks
Assess the pharmacodynamics (PD) of TRL1068 (IL-6)
Time frame: 16 weeks
Assess the pharmacodynamics (PD) of TRL1068 (IL-10)
Time frame: 16 weeks
Assess the pharmacodynamics (PD) of TRL1068 (reinfection)
Time frame: 24 weeks
Assess the immunogenicity of TRL1068 as measured by anti-drug antibodies (ADAs)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 26833157Estelles A, Woischnig AK, Liu K, Stephenson R, Lomongsod E, Nguyen D, Zhang J, Heidecker M, Yang Y, Simon RJ, Tenorio E, Ellsworth S, Leighton A, Ryser S, Gremmelmaier NK, Kauvar LM. A High-Affinity Native Human Antibody Disrupts Biofilm from Staphylococcus aureus Bacteria and Potentiates Antibiotic Efficacy in a Mouse Implant Infection Model. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2292-301. doi: 10.1128/AAC.02588-15. Print 2016 Apr.
- Background: PubMed 28717038Xiong YQ, Estelles A, Li L, Abdelhady W, Gonzales R, Bayer AS, Tenorio E, Leighton A, Ryser S, Kauvar LM. A Human Biofilm-Disrupting Monoclonal Antibody Potentiates Antibiotic Efficacy in Rodent Models of both Staphylococcus aureus and Acinetobacter baumannii Infections. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00904-17. doi: 10.1128/AAC.00904-17. Print 2017 Oct.
- Results publication: PubMed 39012102Conway J, Delanois RE, Mont MA, Stavrakis A, McPherson E, Stolarski E, Incavo S, Oakes D, Salvagno R, Adams JS, Kisch-Hancock A, Tenorio E, Leighton A, Ryser S, Kauvar LM, Bernthal NM. Phase 1 study of the pharmacokinetics and clinical proof-of-concept activity of a biofilm-disrupting human monoclonal antibody in patients with chronic prosthetic joint infection of the knee or hip. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0065524. doi: 10.1128/aac.00655-24. Epub 2024 Jul 16.
- Individual participant dataSharing planned: No. The study results have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Bernthal, MD principal investigator
University of California, Los Angeles
Janet Conway, MD principal investigator
Sinai Hospital of Baltimore
Edward Stolarski, MD principal investigator
Gulfcoast Research Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRL1068, a human monoclonal antibody in people with Prosthetic Joint Infection, run by Trellis Bioscience LLC at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Abnormal Physical Examination Findings (time frame: 16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763759, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.