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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis (OA) of the Knee

In brief

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

Key facts

Study ID

NCT06865079

Run by

OrthoTrophix, Inc

People needed

270

Starts

2025-05-09

Expected to finish

2027-04-15

Last updated by the study team

2026-02-17

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Volunteers will be included in the study only if they satisfy all the following 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).
• Available X-Ray of target knee obtained within 12 months prior to Screening with radiographic evidence of osteoarthritis in the medial and/or lateral tibio-femoral compartment; KL grading is not required.
• Clinical diagnosis of knee OA with at least 2 of the 4 following signs/symptoms in the target knee, and in the absence of palpable warmth suggesting synovitis or infection:
• Crepitus on knee extension
• Bony tenderness
• Bony enlargement
• Morning stiffness in target knee <30 minutes
• Stability of Cruciate and collateral ligaments as defined by clinical examination (e.g. tests such as Lachman, pivot shift, posterior drawer, posterior sag, valgus and Varus stress).
• Results of the KOOS Knee Survey Screening Questionnaire performed at Screening for the target knee that indicate either: moderate or greater difficulty in at least 5 of 17 questions (A1-17) in the "Function, daily living" subsection; or a total score of at least 20/68 in that subsection.
• Results of the KOOS Knee Survey Screening Questionnaire performed at Screening that indicate moderate or greater pain on question P6 "pain going up or down stairs" in the target knee.
• Willing to use only acetaminophen (Tylenol® or equivalent), hydrocodone, orhydrocodone/acetaminophen (e.g., Norco® or equivalent) for breakthrough pain during the4-week injection period. The maximum dose of acetaminophen from all sources must not exceed 4000 mg/day.
• Willing NOT to use non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen (Motrin® or equivalent), or naproxen (Aleve® or equivalent) during the 4-week injection period.
• Willing NOT to use approved or investigational IA products for knee OA for the duration of participation in the study.
• If using GLP-1 medications such as Wegovy® or similar, must be on a stable dose for at least 2 months prior to Screening.
• Female subjects of childbearing potential who are sexually active (non-abstinent) must agree to and comply with using 2 highly effective methods of birth control (oral contraceptive implant, injectable or indwelling intrauterine device, condom with spermicide or sexual abstinence) while participating in the study. Male participants must agree to use a barrier contraception method to prevent pregnancy, and agree not to donate sperm from the time of the first injection through the end of the study.
• Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
• MRI Screening: Tibio-femoral osteoarthritis with MRI based femoral B-score at Screening of 0.5 or greater in at least one knee as determined by central analysis.

You may not qualify if…

• Subjects are excluded from the study if any of the following criteria are met:
• 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.
• 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:
• Zero = No wave produced on down stroke
• Trace = Small wave on medial side with down stroke
• 1+ = Larger bulge on medial side with down stroke
• 2+ = Effusion spontaneously returned to medial side after upstroke (no down stroke necessary)
• 3+ = So much fluid that it was not possible to move the effusion out of the medial aspect of the knee
• Last viscosupplementation (e.g., Synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before Screening.
• Last IA injection of corticosteroids < 2 months before Screening.
• Current (within previous month before Screening) of use of any systemic steroids (except inhaled corticosteroids for allergy or respiratory problems).
• Known hypersensitivity to any of the study drug ingredients.
• Known hypersensitivity to acetaminophen or hydrocodone.
• History of arthroscopy in the target knee in the 3 months before Screening.
• History of septic arthritis, gout, or pseudo-gout in either knee in the year before Screening.
• Clinical signs in the opinion of the Investigator of acute meniscal tear (e.g. locking or acute mechanical signs or symptoms consistent with meniscal tear) in either knee.
• Skin lesion, rash, infection, or hypersensitivity in the target knee at or near the injection site at Screening.
• Bleeding problems, platelet or coagulation deficiency that, in the option of the Investigator, contraindicates IA injection.
• Active systemic infection at Screening or immediately pre-dose on any IA injection day, including chronic viral infection.
• Current treatment or treatment within 2 years prior to Screening for any malignancy except basal cell or squamous cell carcinoma of the skin, prostate or cervical cancer in situ, unless with specific written permission provided by the Sponsor's Medical Monitor.

Where it is running

• Elite Clinical Network — Scottsdale, Arizona, United States
• Noble Clinical Research — Tucson, Arizona, United States
• Legent Orthopedic Hospital — Carrolton, California, United States
• Medvin Clinical Research — Covina, California, United States
• CORE Orthopaedic Medical Center — Encinitas, California, United States
• Marvel Clinical Research (Elite Clinical Network) — Huntington Beach, California, United States
• Medvin Clinical Research Center — Riverside, California, United States
• Medvin Clinical Research Center — Tujunga, California, United States
• Medvin Clinical Research Center — Whittier, California, United States
• K2 Medical Research — Maitland, Florida, United States
• Wellness Research Center — Miami, Florida, United States
• Well Pharma Medical Research — Miami, Florida, United States
• Las Mercedes Medical Research — Miami, Florida, United States
• Drug Studies of America — Marietta, Georgia, United States
• AMR Kansas City — Kansas City, Kansas, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• AMR Lexington — Lexington, Kentucky, United States
• Accurate Clinical Research Inc. — Lake Charles, Louisiana, United States
• Mayo Clinic (Rochester) — Rochester, Minnesota, United States
• Las Vegas Clinical Trials — North Las Vegas, Nevada, United States
• Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
• Center for Clinical Research — Winston-Salem, North Carolina, United States
• Hightower Clinical — Oklahoma City, Oklahoma, United States
• University Orthopedics Center — Altoona, Pennsylvania, United States
• University Orthopedics Center — State College, Pennsylvania, United States

Full record on ClinicalTrials.gov

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