Atibuclimab for Osteoarthritis

Not yet recruiting at 1 trial location
JF
CL
JF
CL
Overseen ByCriswell Lavery, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: VA Office of Research and Development

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Atibuclimab for knee osteoarthritis, a condition that causes chronic pain and disability. The researchers aim to determine if injecting this treatment directly into the knee is safe and potentially effective in reducing pain and improving function. Participants will join one of three groups: a placebo group, a low-dose group, or a high-dose group. The trial seeks individuals who have experienced significant knee pain and swelling. As a Phase 1 trial, this research focuses on understanding how Atibuclimab works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have received corticosteroids in the affected knee within the last 3 months or other intra-articular therapies within the last 6 months, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous research has administered atibuclimab to individuals with other health conditions. For instance, studies involving patients with ALS (a nerve disease) used atibuclimab for long-term treatment. These studies found it safe, with most patients tolerating it well and no major safety issues reported.

This trial marks the first time atibuclimab is tested for knee osteoarthritis (a joint condition). As a Phase 1 trial, the primary goal is to assess its safety when injected directly into the knee joint. This phase indicates that the treatment is in the early stages of testing for this specific condition, so researchers focus on understanding any possible side effects and how patients respond to the treatment.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Atibuclimab for osteoarthritis because it offers a novel approach to treatment. Unlike current options such as NSAIDs or corticosteroids, which primarily address inflammation and pain, Atibuclimab targets the underlying mechanisms of the disease, potentially modifying its progression. Atibuclimab works by modulating the immune response, which could lead to longer-lasting relief and improved joint function. This new mechanism of action sets it apart from standard treatments and holds promise for more effective management of osteoarthritis symptoms.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research suggests that Atibuclimab might help treat knee osteoarthritis (KOA). This treatment uses a special protein to target inflammation, a major cause of pain and damage in osteoarthritis. Other studies have shown Atibuclimab's promise in reducing inflammation, prompting its consideration for KOA. Early research on similar treatments has demonstrated their ability to reduce pain and improve joint function by directly targeting joint inflammation. Although specific data for Atibuclimab in KOA remain limited, its mechanism suggests it could relieve pain and improve joint health by reducing inflammation.15678

Who Is on the Research Team?

JF

Joshua F. Baker, MD MSCE

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for adults with knee osteoarthritis who have moderate to severe pain, visible joint swelling, and meet specific diagnostic criteria. Participants must be able to give informed consent.

Inclusion Criteria

* Kelgren-Lawrence Grade \>1
I have pain rated 5 or higher on a 0-10 scale.
* ACR Classification Criteria for Knee Osteoarthritis
See 2 more

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

Trial Overview

The study is testing a new drug called Atibuclimab injected directly into the knee compared to a saline (salt water) placebo. Participants are randomly assigned to receive either low or high doses of the drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Atibuclimab 20 mg/kgExperimental Treatment1 Intervention
Group II: Placebo (saline only)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Atibuclimab for Osteoarthritis · Info for Participants

This Phase 1 medical study run by VA Office of Research and Development needs participants to evaluate whether Atibuclimab will have tolerable side effects ...

Atibuclimab - Drug Targets, Indications, Patents

Clinical Results associated with Atibuclimab ... Mendelian randomization (MR) was applied to explore correlations between exposure factors and outcomes using GWAS ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40280230/

Intra-articular MM-II for the treatment of knee osteoarthritis ...

Results: Overall, 396 participants received treatment. In the 3 mL MM-II vs placebo group, WOMAC pain numerically improved at week 12 (least ...

4.

clinicaltrials.ucbraid.org

clinicaltrials.ucbraid.org/osteoarthritis

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Out of the 28 studies with 29 RCTs (8555 individuals) included, biologic agents were superior to placebo in pain relief.

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