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

Phase 2

Recruiting

• Conditions: Osteoarthritis (OA) of the Knee
• Interventions: Drug: TPX-100 200mg, Once weekly for 4 weeks; Other: PBS

• Registration Number: NCT06865079
• Lead Sponsor: OrthoTrophix, Inc

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

Detailed Description

This multicenter, double-blind, placebo controlled, randomized study is designed to investigate the safety and efficacy of TPX-100 administered in 4 weekly doses of 200 mg per dose in subjects with tibio-femoral osteoarthritis. The B-score as determined by MRI analysis is the final inclusion criteria, which will be determined by MRI-based assessment. A standardized screening MRI will be obtained on otherwise eligible candidates.

For enrolled subjects, the Screening MRI will serve as the Baseline MRI. Enrolled subjects will be assigned randomly to receive either TPX-100 or PBS placebo, 4 weekly IA injections administered into the target knee by fluoroscopy or ultrasound guidance.

Subjects will undergo follow-up knee MRIs at Week 27 and Week 53 after the first injection. All MRIs will be read by computer-based, standardized methods, blind to treatment assignment and temporal sequence, to provide the imaging outcome measures. Subjects will complete PROs at Week 1 (Baseline), Week 27 and Week 53. A clinical safety evaluation will be performed at Week 13, and a safety tele-visit or telephone call will be performed at Week 36. Adverse events, regardless of causation, and concomitant medications will be documented at all study visits and at the Week 37 tele-visit/telephone call. Clinical laboratory assessments will be obtained at Screening, Baseline (Week 1), and Weeks 2, 3, 4; and at the in-person follow up visits.

All enrolled subjects will be assigned randomly to receive either TPX-100 or PBS placebo, in 4 weekly IA injections administered into the target knee by fluoroscopy or ultrasound guidance.

Study Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Study Start: 2025-05-09
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-09-05
• Primary Completion: 2027-05-25
• Study Completion: 2027-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPX-100 (200 mg per dose)	TPX-100 200mg, Once weekly for 4 weeks	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.
Placebo / PBS	PBS	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.

Primary Outcome Measures

Name	Time	Method
Toxicity Reaction (CTC 5.0 standard）	Baseline to Study Week 27 and Study Week 53	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.

Secondary Outcome Measures

Name	Time	Method
Change in Physical Function & Pain of the Target Knee	Baseline to Study Week 27 and Study Week 53	The Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC®) evaluation scales will be utilized to evaluate patient progression or benefit.; WOMAC® is widely used in the evaluation of Knee Osteoarthritis. It is a patient self-administered questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright; * Stiffness (2 items): after first waking and later in the day; * Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
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	Evaluation of the frequency of pain in the target knee will be evaluated by the KOOS pain scale in which question 1 will be evaluated. Knee injury and Osteoarthritis Outcome Score (KOOS) is an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
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 structural changes in subchondral bone in IA TPX-100-treated versus IA placebo-exposed knees.

Trial Locations

Locations (31)

Accurate Clinical Research Inc.; 🇺🇸 Lake Charles, Louisiana, United States

Center for Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

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; 🇺🇸 Whittier, California, United States

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