Atibuclimab for Osteoarthritis

Overseen By Joshua F Baker, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: VA Office of Research and Development

Must not be taking: Corticosteroids, Visco-supplements

Disqualifiers: Fibromyalgia, Heart failure, Diabetes, Obesity, others

Compensation: Varies

Number of Visits: 1

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

* Kelgren-Lawrence Grade \>1

I have pain rated 5 or higher on a 0-10 scale.

* ACR Classification Criteria for Knee Osteoarthritis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular injections of IC14 or placebo, with patient-reported outcomes assessed at 2-week intervals

3 months

In-person visits at month 1 and 3, with additional assessments every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI scans and synovial fluid analysis

4 months

Regular clinical assessments and monitoring

Long-term follow-up

Participants are monitored for long-term safety and outcomes to inform future studies

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Atibuclimab

How Is the Trial Designed?

Group I: Atibuclimab 40 mg Experimental Treatment 1 Intervention

Group II: Atibuclimab 100 mg Experimental Treatment 1 Intervention

Group III: Placebo (saline only) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+