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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
VA Office of Research and Development
Study ID
NCT07481474
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Knee Osteoarthritis (Knee OA)

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Atibuclimab (intra-articular) — BIOLOGICAL
    Intra-articular injection of Atibuclimab
  • saline placebo — OTHER
    2 mL

Study Details

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 of intra-articular IC14 administration in patients with KOA. A small-scale, Phase I "first-in-joint" 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 injection, (4) evaluate safety profiles of the localized biologic intervention. Participants will be randomized into one of three arms, (a placebo arm, a low-dose arm, and a high-dose arm) and will be followed to evaluate the safety and feasibility of this treatment.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atibuclimab 100 mg
  • Experimental: Atibuclimab 40 mg
  • Placebo Comparator: Placebo (saline only)

Primary Outcome Measure

Rates of screening and randomization [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corporal Michael J. Crescenz Veterans Affairs Medical CenterPhiladelphiaPennsylvania19104
Criswell LM Lavery, MPH
[email protected]
215-823-4630

Find similar trials in Philadelphia, PA

By research site
Corporal Michael J. Crescenz Veterans Affairs Medical Center· Philadelphia, PA

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