NCT07481474

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

Not yet recruiting Phase 1 Last updated 18 March 2026

What this trial tests

Phase 1 trial testing Atibuclimab (intra-articular) in Knee Osteoarthritis (Knee OA) in 30 participants. Not yet recruiting.

Timeline

1 June 2026

Primary endpoint
1 June 2027

1 January 2028

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	1 June 2026
Primary completion	1 June 2027
Estimated completion	1 January 2028
Sites	1 location across United States

Drugs / interventions tested

• Atibuclimab (intra-articular) — full drug profile →
• saline placebo

Conditions studied

• Knee Osteoarthritis (Knee OA) — all drugs for Knee Osteoarthritis (Knee OA) →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 50 to 80, any sex, with Knee Osteoarthritis (Knee OA). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.