Knee osteoarthritis (KOA) is a leading cause of chronic pain and disability among Veterans, which contributes significantly to reduced mobility, impaired quality of life, and increased health care utilization. First-line therapies, including non-steroidal anti-inflammatory drugs, physical therapy, and intra-articular corticosteroids, provide modest and short-term relief, while being associated with other side effects (i.e., potential for hastened cartilage loss) and no disease-modifying potential. Total knee arthroplasty, although effective, is not suitable for all patients and carries surgical risks. There is an unmet need for effective, durable, and locally-targeted therapies that can alleviate pain and improve function. The development of new therapies for this condition is thus a priority for the VA.
While the therapy has been used in humans in other contexts, to date there are no data on the safety, feasibility, and potential efficacy IC14 administration in patients with KOA. A small-scale, Phase I pilot and feasibility trial is therefore critical to inform the design and implementation of larger, definitive studies. Specifically, preliminary data are needed to (1) determine the appropriate inclusion/exclusion criteria, (2) solidify the study design and study processes,(3) assess patient tolerance and acceptability of i.a. mAb infusion for KOA, (4) evaluate safety profiles of the localized biologic intervention. Participants will be randomized into one of two arms, (a placebo arm, and active atibuclimab arm (2 mg/kg)) and will be followed to evaluate the safety and feasibility of this treatment.
ACR Classification Criteria for Knee Osteoarthritis
Pain >=5 on Visual Analogue Scale
Kelgren-Lawrence Grade >1
Joint Effusion on Exam
Serious or hospitalized infection in last 1 year
Poorly controlled crystal arthritis in last 6 months
Pain Pressure Threshold (PPT) testing <=3
History of diagnosed fibromyalgia
Parallel
Atibuclimab
Biological/VaccineIV injection of Atibuclimab
saline placebo
Other interventionIV infusion of saline
Rates of screening and randomization
The number of randomized participants relative to the number screened. The screening protocol will be considered feasible if 1/2 of screened patients are eligible to be randomized.
Rates of study completion
Rates of completion of study procedures. The design will be considered to be feasible if 90% complete 4-month follow-up from randomization.
Rates of serious adverse events
The study will quantify emergency room visits, hospitalizations, and life-threatening events and determine relatedness. Rates will be quantified over 4 months of follow-up and evaluated descriptively by group.
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