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NCT06621251 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection
A Phase 2 study of Prosthetic Joint Infections of Hip and Prosthetic Joint Infections of Knee, sponsored by Trellis Bioscience.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 17
- Study locations
NCT06621251: Recruiting Phase 2 study of Prosthetic Joint Infections of Hip and Prosthetic Joint Infections of Knee, sponsored by Trellis Bioscience.
NCT06621251 is a Phase 2 study of Prosthetic Joint Infections of Hip and Prosthetic Joint Infections of Knee that is actively recruiting participants, run by Trellis Bioscience. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06621251, a Phase 2 study of Prosthetic Joint Infections of Hip and Prosthetic Joint Infections of Knee, is actively recruiting participants, sponsored by Trellis Bioscience.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 17
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG TRL1068 (calpurbatug), a human monoclonal antibody
- PROCEDURE DAIR
Study Locations (17)
Texas
- Proactive RGV - Brownsville
- University of Texas Medical Branch at Galveston - Galveston
- Houston Methodist - Houston
- Paradigm Research Center - Houston
- North Texas Medical Research Institute - Rockwall
Florida
- Mayo Clinic Jacksonville - Jacksonville
- Gulfcoast Research Institute - Sarasota
- Phoenix Clinical Research - Tamarac
New York
- NYU Langone Health - New York
- University of Rochester - Rochester
Arizona
- OrthoArizona - Gilbert
Arkansas
- University of Arkansas for Medical Sciences (UAMS) - Little Rock
California
- UCLA - Los Angeles
Maryland
- Sinai Hospital Baltimore - Baltimore
Massachusetts
- New England Baptist Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-04-08 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What NCT06621251 shows while recruiting
NCT06621251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 2 conditions, with Prosthetic Joint Infections of Hip appearing as the primary indexed condition, and to 2 interventions - of which TRL1068 (calpurbatug), a human monoclonal antibody is the first listed.
NCT06621251 lists 17 locations in 10 states (Texas, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT06621251 about?
NCT06621251 is a clinical study titled "Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection". 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 w...
What is the current status of trial NCT06621251?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-04-08. Estimated completion is 2026-11.
What conditions does trial NCT06621251 study?
This clinical trial studies the following conditions: Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee.
What interventions are being tested in trial NCT06621251?
The interventions under investigation include: TRL1068 (calpurbatug), a human monoclonal antibody (DRUG), DAIR (PROCEDURE).
Who is sponsoring clinical trial NCT06621251?
This trial is sponsored by Trellis Bioscience, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06621251 being conducted?
This trial has 17 study locations across Arizona, Arkansas, California, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06621251's enrollment target sits among peer trials
60 1027th of 2000 higher than 869 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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