NCT07481474

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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Jan 2028

First Submitted

Initial submission to the registry

March 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 13, 2026

Last Update Submit

March 13, 2026

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 (3)

Atibuclimab 100 mg

EXPERIMENTAL
Biological: Atibuclimab (intra-articular)

Atibuclimab 40 mg

EXPERIMENTAL
Biological: Atibuclimab (intra-articular)

Placebo (saline only)

PLACEBO COMPARATOR
Other: saline placebo

Interventions

Atibuclimab (intra-articular)BIOLOGICAL

Intra-articular injection of Atibuclimab

Atibuclimab 100 mgAtibuclimab 40 mg
saline placeboOTHER

2 mL

Placebo (saline only)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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%)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporal Michael J. Crescenz Veterans Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

atibuclimab

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Joshua F Baker, MD, MSCE

CONTACT

215-823-5800joshua.baker@va.gov

Criswell LM Lavery, MPH

CONTACT

215-823-4630

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

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

US(1)