Pilot and Feasibility Study of Anti-CD14 for the Treatment of Knee Osteoarthritis

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Knee Osteoarthritis (Knee OA)

In brief

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.

Key facts

Study ID

NCT07481474

Run by

VA Office of Research and Development

People needed

40

Starts

2027-01-01

Expected to finish

2028-01-01

Last updated by the study team

2026-07-15

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ACR Classification Criteria for Knee Osteoarthritis
• Pain >=5 on Visual Analogue Scale
• Kelgren-Lawrence Grade >1
• Joint Effusion on Exam
• Able to provide informed consent

You may not qualify if…

• 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
• Receipt of corticosteroid in affected knee within 3 months
• Receipt of visco-supplementation or other intra-articular therapy (other than corticosteroid) within 6 months
• Ongoing participation in another interventional study
• Inability to ambulate without assistive device
• Pregnancy or Lactation
• History of knee arthroplasty in either knee
• Symptomatic heart failure
• Glomerular filtration rate <45
• Class III obesity (BMI>40 kg/m2)
• Recent active malignancy (chemotherapy, radiation, or surgery within 3 months)
• Poorly controlled diabetes (A1c>8%)
• Rheumatoid Arthritis
• Psoriatic Arthritis

Where it is running

• Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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