TPX-100 for Knee Arthritis

Recruiting at 20 trial locations

Overseen By Ernest R. Kitt, BS MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: OrthoTrophix, Inc

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

Compensation: Varies

Number of Visits: 0

270 Participants Needed

Trial Summary

What is the purpose of this trial?

53-Week Study Evaluating the Safety and Efficacy of Intra-articular (IA) Injections of TPX-100 vs Placebo in Subjects with Mild to Severe Tibio-Femoral Osteoarthritis of the Knee

Research Team

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

Principal Investigator

OrthoTrophix, Inc

Eligibility Criteria

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

I can read and understand the consent form and am able to sign it.

I have no physical conditions that would stop me from following the trial's requirements.

I have an X-Ray of my knee showing arthritis, taken in the last year.

Treatment Details

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.

Participant Groups

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+