53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mi… (NCT06865079) | Clinical Trial Compass
Active — Not RecruitingPhase 2
53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mild to Severe Tibio-Femoral Osteoarthritis of the Knee
United States270 participantsStarted 2025-05-09
Plain-language summary
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
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to read, understand, sign, and date the subject informed consent.
. Have given written informed consent before any study-related activities are carried out and are able to understand the nature and purpose of the trial, including possible risks and adverse effects.
. Adult males and females, 50 to 80 years of age (inclusive) at Screening.
. Body weight less than 136 kgs (300 lbs) at Screening.
. Except for OA, subject is medically healthy (in the opinion of the PI), as determined by prestudy medical history, and without clinically significant abnormalities including:
. Clinically relevant findings on physical examination that would preclude trial compliance.
. Heart rate \<40 BPM or \>100 BPM after 5 minutes rest in supine or semi-supine position.
. Body temperature \<95.9°F or \>99.8°F. Note: The above assessments may be repeated, if abnormal values are recorded in the first instance, at the discretion of the Investigator (or delegate).
Exclusion criteria
. Contraindication to MRI.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Toxicity Reaction (CTC 5.0 standard）
Timeframe: Baseline to Study Week 27 and Study Week 53
. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the volunteer's ability to participate in the trial.
. Prior surgery in the target knee, excluding procedures for debridement only (no previous micro-fracture procedure).
. Knee joint replacement or any other knee surgery planned in either knee while participating in the study.
. Moderate or severe pain in the contralateral (non-target) knee.
. History of fibromyalgia, rheumatoid arthritis (RA), psoriatic arthritis, or any other autoimmune or infectious cause for arthritis; or referred knee pain from hip or spinal disease.
. Knee effusion \>2+ on the following clinical scale: