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

NCT07481474 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: RRDC-003-23S-T11915270
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• Rates of study completion

  2 years

• Rates of serious adverse events

  4 months

Study Arms (2)

Atibuclimab 20 mg/kg

EXPERIMENTAL

IV infusion of atibuclimab

Biological: Atibuclimab

Placebo (saline only)

PLACEBO COMPARATOR

placebo infusion of saline

Other: saline placebo

Interventions

saline placebo OTHER

IV infusion of saline

Placebo (saline only)

Atibuclimab BIOLOGICAL

IV injection of Atibuclimab

Atibuclimab 20 mg/kg

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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%)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

atibuclimab

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Joshua F. Baker, MD MSCE

  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua F Baker, MD MSCE

CONTACT

(215) 823-5800; Joshua.Baker@va.gov

Criswell Lavery, MPH

CONTACT

(215) 823-4630; criswell.lavery@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)