Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-10 @ 10:25 PM
Study NCT ID:
NCT06621251
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2024-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627168', 'term': 'TRL1068'}, {'id': 'D003646', 'term': 'Debridement'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunogenicity of TRL1068 as measured by anti-drug antibodies (ADAs)', 'timeFrame': 'Day 365', 'description': 'The exploratory objective is to assess the immunogenicity of TRL1068 as measured by anti-drug antibodies (ADAs).'}, {'measure': 'Pharmacokinetics - serum and synovial concentrations of TRL1068', 'timeFrame': 'Day 365', 'description': 'Serum and synovial concentrations of TRL1068 will be determined by ELISA'}, {'measure': 'Pharmacodynamics - inflammatory biomarkers - CRP', 'timeFrame': 'Day 365', 'description': 'CRP will be compared within and across groups'}, {'measure': 'Pharmacodynamics - inflammatory biomarkers - ESR', 'timeFrame': 'Day 365', 'description': 'ESR will be compared within and across groups'}], 'primaryOutcomes': [{'measure': 'Efficacy of TRL1068 in eliminating the need for an SoC 2-stage exchange arthroplasty', 'timeFrame': 'Day 365', 'description': 'Incidence of resolved PJI, i.e., completion of planned surgical interventions for PJI (DAIR or 2-stage exchange arthroplasty), and not receiving systemic antibiotics for PJI or antibiotic suppression therapy for PJI or any other planned interventions to treat PJI by end of study.'}], 'secondaryOutcomes': [{'measure': 'Duration (days) with resolved PJI', 'timeFrame': 'Day 365', 'description': 'Days after completion of planned surgical interventions for PJI (DAIR or 2-stage exchange arthroplasty) without receiving systemic antibiotics for PJI or antibiotic suppression therapy of PJI or any other planned interventions to treat PJI by end of study.'}, {'measure': 'Incidence of recurrent PJI across treatment groups', 'timeFrame': 'Day 365', 'description': 'Recurrent PJI will include PJI in which the causative pathogen of the recurrent PJI was not identified at baseline.'}, {'measure': 'Incidence of PJI reinfection across treatment groups', 'timeFrame': 'Day 365'}, {'measure': 'Incidence, duration and severity of AEs or SAEs of secondary infections', 'timeFrame': 'Day 365'}, {'measure': 'Musculoskeletal Infection Society (MSIS) Scores', 'timeFrame': 'Day 365', 'description': 'MSIS scores on Day 1, day of DAIR (Day 15 + 7 days) versus Day 1, day of first stage of SoC and EOS (Day 365) that are indicative of the presence of PJI. MSIS Minor Criteria score range is 0-12, above or equal to 6 is infected, 2-5 is possibly infected, 0-1 is not infected.'}, {'measure': 'Quality of life PROMIS-PF Short Form 6b', 'timeFrame': 'Day 365', 'description': 'Quality of life as measured by the Quality of Life (QoL) Questionnaire (PROMIS-PF Short Form 6b). Score range is 6-30, with higher scores indicating higher functioning.'}, {'measure': 'Resource utilization: duration of hospitalization as a result of PJI, SoC or surgical wound infection', 'timeFrame': 'Day 365'}, {'measure': 'Resource utilization: need to stay in a rehabilitation center or other institution, e.g., nursing home as a result of PJI, SoC or surgical wound infection', 'timeFrame': 'Day 365'}, {'measure': 'Incidence, duration and severity of AEs and SAEs across treatment groups', 'timeFrame': 'Day 365', 'description': 'abnormal vital signs and safety labs will be documented as adverse events.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biofilm', 'antibiotic-resistant infections'], 'conditions': ['Prosthetic Joint Infections of Hip', 'Prosthetic Joint Infections of Knee']}, 'referencesModule': {'references': [{'pmid': '39012102', 'type': 'RESULT', 'citation': 'Conway 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.'}]}, 'descriptionModule': {'briefSummary': 'TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens. This Phase 2 study is designed to assess efficacy and safety of TRL1068 in combination with a DAIR (debridement, antibiotics, and implant retention) procedure for chronic prosthetic joint infections of the knee and hip, specifically, eliminating the need for the standard of care 2-stage exchange surgery, so that the original prosthesis can be retained.', 'detailedDescription': '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 and in the first-in-human Phase 1 study TRL1068-101 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 to 85 years, inclusive\n2. Chronic PJI:\n\n 1. Systemic Host Grade of A or B \\[McPherson 2011\\] (Appendix 3) and either\n 2. First chronic PJI of the hip or knee, confirmed by synovial fluid aspirate culture or\n 3. Recurrent chronic PJI of the hip or knee confirmed by synovial fluid aspirate culture\n3. Willing to be randomized to either:\n\n 1. Receive TRL1068 and to be scheduled for DAIR between Day 15 + 7 days (i.e., between days 15-22) and 10 weeks of targeted antibiotic treatment or\n 2. Participate in an observational study arm that receives SoC (i.e., two-stage prosthetic joint replacement) and\n\n i. Sonication of the explanted prosthesis and performance of synovial fluid aspirates ii. Consents to conduct of stage 2 (implantation of new prosthesis)\n4. At least 1 positive bacterial culture without concomitant fungal infection from the infected joint (a joint aspirate within 28 days prior to Screening is acceptable)\n5. All identified pathogen(s) are susceptible to the planned antibiotic regimen\n6. Availability of radiology assessments of the affected joint without signs of loosening of the prosthesis or presence of osteomyelitis\n7. Willing and able to provide written informed consent\n8. Willing to perform and comply with all study procedures, including attending clinic visits as scheduled\n9. Men and women of childbearing potential (WOCBP) must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device (IUD), or use of spermicide combined with a barrier method (e.g., condom, diaphragm) through Day 365.\n\nExclusion Criteria:\n\n1. PJI associated with presence of concomitant fungal infection or bacterial pathogens that, even when in planktonic form (i.e., when released from biofilm), cannot be adequately treated with available antibiotics.\n2. More than one draining sinus and single draining sinus of \\> 1 cm\n3. Less than 3 years life expectancy based on underlying morbidities\n4. Expected to receive chronic suppressive antibiotic therapy\n5. Congestive heart failure; New York Heart Association (NYHA) Functional Classification of Heart Failure Grade \\> 3B\n6. Uncontrolled diabetes, defined as hemoglobin A1c \\> 7.4%.\n7. BMI \\> 45\n8. Any acute illness within 14 days of Day 1 that could confound the evaluation of safety evaluation of TRL1068, especially local or systemic fungal and other known or suspected bacterial infections\n9. Receiving or recently received another investigational drug (within 30 days of Day 1, or 5 half-lives of the investigational drug, whichever is longer)\n10. Received any vaccine within 14 days prior to Day 1\n11. Positive serum pregnancy test for WOCBP, or nursing women\n12. History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with all study requirements\n13. Any other comorbidity or condition that, in the opinion of the Investigator would make the patient unsuitable for the study or unable to comply with the study requirements."}, 'identificationModule': {'nctId': 'NCT06621251', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trellis Bioscience LLC'}, 'officialTitle': 'Phase 2 Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Chronic Prosthetic Joint Infection of the Knee or Hip Without Exchange Arthroplasty', 'orgStudyIdInfo': {'id': 'TRL1068-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRL1068 + DAIR', 'description': 'TRL1068 will be administered at 15 mg/kg IV on Day 1 and subsequently at 7.5 mg/kg on Days 15, 29, and 43. Between Day 15-22, a DAIR procedure will be completed.', 'interventionNames': ['Drug: TRL1068 (calpurbatug), a human monoclonal antibody', 'Procedure: DAIR']}, {'type': 'NO_INTERVENTION', 'label': 'SoC', 'description': 'Standard of Care arm, receiving 2-stage surgery as is SoC for PJI. Reduced assessments will be done at the same timepoints as the experimental arm.'}], 'interventions': [{'name': 'TRL1068 (calpurbatug), a human monoclonal antibody', 'type': 'DRUG', 'description': 'A human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody', 'armGroupLabels': ['TRL1068 + DAIR']}, {'name': 'DAIR', 'type': 'PROCEDURE', 'otherNames': ['debridement, antibiotics, and implant retention'], 'description': 'DAIR procedure will be performed between days 15-22', 'armGroupLabels': ['TRL1068 + DAIR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brittany Damiano', 'role': 'CONTACT', 'email': 'b.damiano@prgresearch.com', 'phone': '800-774-1534', 'phoneExt': '703'}, {'name': 'Kipling Sharpe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OrthoArizona', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alceson Niemi', 'role': 'CONTACT', 'email': 'aniemi@uams.edu', 'phone': '847-370-0205'}, {'name': 'Jeffery Stambough, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arkansas for Medical Sciences (UAMS)', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie Argueta, MS', 'role': 'CONTACT', 'email': 'darguetarufino@mednet.ucla.edu', 'phone': '310-210-6829'}, {'name': 'Alexandra Stavrakis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bre Jenkins, MPH', 'role': 'CONTACT', 'email': 'jenkins.breana@mayo.edu', 'phone': '904-953-4605'}, {'name': 'Cameron Ledford, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': "Jesse D'Alessio, CCRC", 'role': 'CONTACT', 'email': 'jdalessio@gulfcoast-research.com', 'phone': '941-552-7875'}, {'name': 'Edward Stolarski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gulfcoast Research Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steffanie Littleton', 'role': 'CONTACT', 'email': 's.littleton@phoenixclinical.com', 'phone': '754-205-5000'}, {'name': 'Richard Berkowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Phoenix Clinical Research', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Taj-Jamal Andrews', 'role': 'CONTACT', 'email': 'tandrews@lifebridgehealth.org', 'phone': '410-601-9592'}, {'name': 'Janet Conway, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sinai Hospital Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sade Olatunbosun', 'role': 'CONTACT', 'email': 'folatunb@nebh.org', 'phone': '617-754-6732'}, {'name': 'Brian Hollenbeck, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New England Baptist Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Waren', 'role': 'CONTACT', 'email': 'daniel.waren@nyulangone.org', 'phone': '212-598-6358'}, {'name': 'Ran Schwarzkopf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Owens, CCRC', 'role': 'CONTACT', 'email': 'Ashley_Owens@URMC.Rochester.edu', 'phone': '585-953-7370'}, {'name': 'Benjamin Ricciardi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28412', 'city': 'Wilmington', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shandelle Phelps (Parker), CCRC', 'role': 'CONTACT', 'email': 'sparker@wakeresearch.com', 'phone': '919-781-2514', 'phoneExt': '1601'}, {'name': 'Jeremy Hoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M3 Wake Research Associates', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '78520', 'city': 'Brownsville', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Juan Carlos Marquez, MD', 'role': 'CONTACT', 'email': 'jmarquez@proactivecr.com', 'phone': '956-731-1260'}, {'name': 'Raul Marquez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Proactive RGV', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Liz Hennessy, RN, CCRP', 'role': 'CONTACT', 'email': 'eahennes@utmb.edu', 'phone': '409-772-2138'}, {'name': 'Paul Dicpinigaitis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Medical Branch at Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas Sullivan, CCRC', 'role': 'CONTACT', 'email': 'tsullivan@houstonmethodist.org', 'phone': '346-238-1603'}, {'name': 'Kwan Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cynthia Stewart, CCRC, CCRA', 'role': 'CONTACT', 'email': 'cynthia@paradigmcrc.com', 'phone': '832-264-7141'}, {'name': 'James Carson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Paradigm Research Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75087', 'city': 'Rockwall', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffery Neumann, PA', 'role': 'CONTACT', 'email': 'jneumann@dallasortho.net', 'phone': '817-903-0822'}, {'name': 'Bruno Gross, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Texas Medical Research Institute', 'geoPoint': {'lat': 32.93123, 'lon': -96.45971}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shanna Loughmiller, MPH', 'role': 'CONTACT', 'email': 'shanna.loughmiller@hsc.utah.edu', 'phone': '801-587-5499'}, {'name': 'Jeremy Gililland, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Anton Leighton, MD', 'role': 'CONTACT', 'email': 'Clinicalstudies@trellisbio.com', 'phone': '650-838-1400'}, {'name': 'Adriane Kisch-Hancock', 'role': 'CONTACT', 'email': 'akisch-hancock@trellisbio.com', 'phone': '650-838-1400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study results will be published after the study is completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trellis Bioscience LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}