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 range50 Years – 80 Years
SexALL
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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.
✕. 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.
What they're measuring
1
Toxicity Reaction (CTC 5.0 standard）
Timeframe: Baseline to Study Week 27 and Study Week 53
. 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: