A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYSâ„¢) in Knee Osteoarthritis Patients (NCT07219771) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYSâ„¢) in Knee Osteoarthritis Patients
United States260 participantsStarted 2025-10-14
Plain-language summary
This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis.
The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to placebo over a 52-week period in participants with radiographic and symptomatic knee OA.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Males and females aged 40 to 80 years.
✓. Presenting with symptomatic knee OA with Kellgren-Lawrence (KL) radiographic classification of 2 or 3 (mild or moderate), as assessed by the central reading facility.
✓. Primary source of pain throughout the body is due to OA in the target knee.
✓. Target knee pain ≥ 20 and ≤ 40 out of 50 on the WOMAC® numerical rating scale (NRS) 3.1 pain questionnaire (sum of 5 questions) at Screening and Baseline.
✓. Onset of symptomatic OA of the target knee was at least 6 months prior to Screening.
✓. Insufficient, failed response, or intolerance to analgesics and / or non-steroidal anti-inflammatory drugs (NSAIDs), as reported by the participant.
✓. If female, must meet all of the following:
✓. Not breast feeding,
Exclusion criteria
✕. Participant is non-ambulatory (unable to walk \> 50 feet / 15 meters without assistance).
✕. Clinically severe obesity as defined by the National Institutes of Health (body mass index ≥ 40 kg/m2) at Screening and / or Baseline.
✕. Contralateral (non-target) knee pain is ≥ 10 out of 50 on the WOMAC® NRS 3.1 pain questionnaire (sum of 5 questions) at Screening or at Baseline.
✕
What they're measuring
1
Proportion of participants meeting strict responder criteria for improvement in knee function.
Timeframe: 6 months
2
Proportion of participants meeting strict responder criteria for improvement in knee pain.
. At Baseline, difference between the first Baseline and second Baseline WOMAC pain scores is ≥ 3 for the target knee.
✕. Contralateral (non-target) knee pain is experienced for ≥ 14 days in the month.
✕. Use of any analgesia during the washout period (5 half-lives) at Screening or Baseline.
✕. Participation in any investigational study within 30 days (or 5 half-lives, whichever is longer) prior to Screening or planning to participate in any other investigational drug or device clinical trials within 30 days of study completion.
✕. Currently requires use of a lower extremity prosthesis and / or a structural knee brace (ie, a knee brace that contains hardware).