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
A Randomized, Double-blind, Placebo-controlled, 53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Severe Tibio- Femoral Osteoarthritis of the Knee
1 other identifier
interventional
270
1 country
33
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2025
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2025
CompletedFirst Posted
Study publicly available on registry
March 7, 2025
CompletedStudy Start
First participant enrolled
May 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 15, 2027
February 17, 2026
February 1, 2026
1.9 years
February 25, 2025
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Toxicity Reaction (CTC 5.0 standard）
CTC 5.0, also known as Common Terminology Criteria for Adverse/Serious Adverse Events version 5.0, is an extensively used classification system for assessing drug toxicity. This system categorizes drug toxicity into five levels: Grade 0, Grade 1, Grade 2, Grade 3, and Grade 4.
Baseline to Study Week 27 and Study Week 53
Secondary Outcomes (3)
Change in Physical Function & Pain of the Target Knee
Baseline to Study Week 27 and Study Week 53
Change in MRI-based femoral B-score which ranges from -2 to +7, with higher scores indicating greater severity
Baseline to Study Week 27 and Study Week 53
To evaluate Pain Frequency in the Target Knee by KOOS evaluation of question 1 which ranges from 0 (Never) - 4 (Always).
Baseline to Study Week 27 and Study Week 53
Study Arms (2)
TPX-100 (200 mg per dose)
EXPERIMENTALTPX-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.
Placebo / PBS
PLACEBO COMPARATORPBS 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.
Interventions
TPX-100 (200 mg per dose) will be administered once-weekly (Week 1, 2, 3 \& 4) to a single target knee of the subject for 4 injections. TPX-100 can be administered by conventional methods such as subcutaneous or intra-articular injection.
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
Eligibility Criteria
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
- +10 more criteria
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
- + = Larger bulge on medial side with down stroke
- + = Effusion spontaneously returned to medial side after upstroke (no down stroke necessary)
- + = 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Elite Clinical Network
Scottsdale, Arizona, 85260, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Legent Orthopedic Hospital
Carrolton, California, 75006, United States
Medvin Clinical Research
Covina, California, 91722, United States
CORE Orthopaedic Medical Center
Encinitas, California, 92024, United States
Marvel Clinical Research (Elite Clinical Network)
Huntington Beach, California, 92647, United States
Medvin Clinical Research Center
Riverside, California, 92518, United States
Medvin Clinical Research Center
Tujunga, California, 91042, United States
Medvin Clinical Research Center
Whittier, California, 90602, United States
K2 Medical Research
Maitland, Florida, 32751, United States
Wellness Research Center
Miami, Florida, 33135, United States
Well Pharma Medical Research
Miami, Florida, 33173, United States
Las Mercedes Medical Research
Miami, Florida, 33196, United States
Drug Studies of America
Marietta, Georgia, 30060, United States
AMR Kansas City
Kansas City, Kansas, 64114, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
AMR Lexington
Lexington, Kentucky, 40509, United States
Accurate Clinical Research Inc.
Lake Charles, Louisiana, 70605, United States
Mayo Clinic (Rochester)
Rochester, Minnesota, 55905, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
University Orthopedics Center
Altoona, Pennsylvania, 16602, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
AMR Knoxville
Knoxville, Tennessee, 37909, United States
Accurate Clinical Research, LLC
Baytown, Texas, 77521, United States
Texas Orthopedic Specialist
Bedford, Texas, 76021, United States
First Surgical Hospital
Bellaire, Texas, 77401, United States
Accurate Clinical Research
Houston, Texas, 77089, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
CenExel
Salt Lake City, Utah, 84107, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dawn McGuire - Chief Medical Officer, M.D. FAAN
OrthoTrophix, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Clinical Research Organizations (CROs) Sponsor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2025
First Posted
March 7, 2025
Study Start
May 9, 2025
Primary Completion (Estimated)
March 25, 2027
Study Completion (Estimated)
April 15, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02