TPX-100 for Knee Arthritis

Recruiting at 2 trial locations

Overseen By Ernest R. Kitt, BS MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: OrthoTrophix, Inc

Must not be taking: Systemic steroids, Paclitaxel

Disqualifiers: Rheumatoid arthritis, Fibromyalgia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment, TPX-100, for knee osteoarthritis. Participants will receive injections directly into the knee joint and will be compared to those receiving a placebo. The trial focuses on individuals with mild to severe knee osteoarthritis who experience symptoms like creaky joints, joint tenderness, or morning stiffness lasting less than 30 minutes. Those who often have knee pain that makes daily activities difficult might be a good fit for this study. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

During the 4-week injection period, you can only use acetaminophen, hydrocodone, or hydrocodone/acetaminophen for pain relief. You must avoid non-steroidal anti-inflammatory drugs like aspirin, ibuprofen, or naproxen during this time.

Is there any evidence suggesting that TPX-100 is likely to be safe for humans?

Research has shown that TPX-100 has been tested for safety in people. In these studies, researchers injected TPX-100 into the knee and monitored it over time. Patients who received TPX-100 experienced a noticeable delay in changes to bone shape, suggesting the treatment's effectiveness. Importantly, these studies reported no major safety issues, which is reassuring.

However, since these results come from mid-phase trials, TPX-100 has shown some safety in people, but more research is needed for complete certainty. Researchers continue to study this treatment carefully to confirm these findings and ensure its safety for everyone. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TPX-100 for knee arthritis because it represents a novel approach to treatment. Unlike current options like NSAIDs, corticosteroids, and hyaluronic acid injections, TPX-100 is designed to be injected directly into the knee joint, potentially promoting tissue regeneration rather than just reducing inflammation or lubricating the joint. This unique mechanism targets the underlying issues of cartilage degradation, aiming to improve joint function and slow disease progression. If successful, TPX-100 could offer patients not just symptom relief, but also a chance at long-term improvement in knee health.

What evidence suggests that TPX-100 might be an effective treatment for knee arthritis?

Research has shown that TPX-100, which participants in this trial may receive, can help treat knee osteoarthritis. In one study, knees treated with TPX-100 exhibited less change in bone shape compared to those given a placebo after 6 and 12 months, suggesting that TPX-100 might slow joint damage. Additionally, TPX-100 provided noticeable and lasting improvements for people with knee osteoarthritis. These findings suggest that TPX-100 could help manage symptoms and improve joint health for those with knee arthritis. ^{1 2 3 4 6}

Who Is on the Research Team?

Dawn McGuire - Chief Medical Officer, M.D. FAAN

Principal Investigator

OrthoTrophix, Inc

Are You a Good Fit for This Trial?

This trial is for adults aged 50-80 with mild to severe knee osteoarthritis, weighing less than 300 lbs. Participants must understand the study and consent to it. Exclusions include abnormal physical exam findings that affect compliance, extreme body temperatures, heart rate abnormalities, and lack of recent knee X-rays.

Inclusion Criteria

Do you feel pain in your affected joints most days?

Has a doctor ever told you that X-rays show arthritis in your knee(s) or hip(s)?

Exclusion Criteria

Are you planning knee or hip surgery in the next year?

Has a doctor diagnosed you with rheumatoid arthritis, psoriatic arthritis, or gout?

Do you take daily opioids or medical cannabis for joint pain?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 4 weekly intra-articular injections of TPX-100 or placebo

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness with follow-up MRIs and PROs

49 weeks

3 visits (in-person), 1 tele-visit

What Are the Treatments Tested in This Trial?

Interventions

• TPX-100

Trial Overview The study tests TPX-100 injections against a placebo in patients with knee osteoarthritis over 53 weeks. It aims to assess safety and effectiveness in reducing joint pain and improving function compared to a non-active treatment.

How Is the Trial Designed?

Group I: TPX-100 (200 mg per dose) Experimental Treatment 1 Intervention

TPX-100 (200 mg per dose) for intra-articular injection administered once-weekly (Week 1, 2, 3 and 4) to a single target knee of the subject for 4 injections.

Group II: Placebo / PBS Placebo Group 1 Intervention

PBS placebo for intra-articular injection administered once-weekly (Week 1, 2, 3 and 4) to a single target knee of the subject for 4 injections.

Who Is Running the Clinical Trial?

OrthoTrophix, Inc

Lead Sponsor

Trials

4

Recruited

460+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8447757/

intra-articular TPX-100 significantly delays pathological bone ... TPX-100-treated knees (n = 78) demonstrated a statistically significant decrease in pathologic bone shape change compared with placebo-treated knees at 6 and 12 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06865079

NCT06865079 | 53-Week Study Evaluating the Safety and ... This multicenter, double-blind, placebo controlled, randomized study is designed to investigate the safety and efficacy of TPX-100 administered in 4 weekly ...

3. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-021-02622-8

intra-articular TPX-100 significantly delays pathological bone ... TPX-100-treated knees (n = 78) demonstrated a statistically significant decrease in pathologic bone shape change compared with placebo-treated ...

4. oarsijournal.com oarsijournal.com/article/S1063-4584(18)30602-2/fulltext

TPX-100 leads to marked, sustained improvements in ... TPX-100 leads to marked, sustained improvements in subjects with knee osteoarthritis: pre-clinical rationale and results of a controlled clinical trial.

5. trials.arthritis.org trials.arthritis.org/trials/NCT06865079

53-Week Study Evaluating the Safety and Efficacy of Intra ... This multicenter, double-blind, placebo controlled, randomized study is designed to investigate the safety and efficacy of TPX-100 administered in 4 weekly ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01925261

A Study Evaluating the Safety and Efficacy of Intra-articular ... This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino acid chondrogenic peptide, delivered by intra-articular injection, ...