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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

NCT06865079 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-02-17

No results posted yet for this study

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

Conditions

  • Osteoarthritis (OA) of the Knee

Interventions

DRUG

TPX-100 200mg, Once weekly for 4 weeks

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.

OTHER

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

Sponsors & Collaborators

  • OrthoTrophix, Inc

    lead INDUSTRY

Principal Investigators

  • Dawn McGuire - Chief Medical Officer, M.D. FAAN · OrthoTrophix, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-09
Primary Completion
2027-03-25
Completion
2027-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06865079 on ClinicalTrials.gov