Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection

Conditions

• Prosthetic Joint Infections of Hip
• Prosthetic Joint Infections of Knee

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• TRL1068 (calpurbatug), a human monoclonal antibody — DRUG
  A human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody
• DAIR — PROCEDURE
  DAIR procedure will be performed between days 15-22

Study Details

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.

Key Dates

Start date

Apr 8, 2025

Status verified

May 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TRL1068 + DAIR
  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.
• No Intervention: SoC
  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.

Primary Outcome Measure

Efficacy of TRL1068 in eliminating the need for an SoC 2-stage exchange arthroplasty [ Time Frame: Day 365 ]

Locations (11)

Find similar trials in Gilbert, AZ

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