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

NCT07481474 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-15

No results posted yet for this study

Summary

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.

Conditions

  • Knee Osteoarthritis (Knee OA)

Interventions

BIOLOGICAL

Atibuclimab

IV injection of Atibuclimab

OTHER

saline placebo

IV infusion of saline

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Joshua F. Baker, MD MSCE · Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2027-06-01
Completion
2028-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481474 on ClinicalTrials.gov