A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients
Eligible age
40–80 yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: Doron Therapeutics Inc.
You may qualify if…
- ✓ 1. Males and females aged 40 to 80 years.
- ✓ 2. 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.
- ✓ 3. Primary source of pain throughout the body is due to OA in the target knee.
- ✓ 4. 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.
- ✓ 5. Onset of symptomatic OA of the target knee was at least 6 months prior to Screening.
- ✓ 6. Insufficient, failed response, or intolerance to analgesics and / or non-steroidal anti-inflammatory drugs (NSAIDs), as reported by the participant.
- ✓ 7. If female, must meet all of the following:
- ✓ 1. Not breast feeding,
You may not qualify if…
- ✕ 1. Participant is non-ambulatory (unable to walk \> 50 feet / 15 meters without assistance).
- ✕ 2. Clinically severe obesity as defined by the National Institutes of Health (body mass index ≥ 40 kg/m2) at Screening and / or Baseline.
- ✕ 3. 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.
- ✕ 4. At Baseline, difference between the first Baseline and second Baseline WOMAC pain scores is ≥ 3 for the target knee.
- ✕ 5. Contralateral (non-target) knee pain is experienced for ≥ 14 days in the month.
- ✕ 6. Use of any analgesia during the washout period (5 half-lives) at Screening or Baseline.
- ✕ 7. 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.
- ✕ 8. Currently requires use of a lower extremity prosthesis and / or a structural knee brace (ie, a knee brace that contains hardware).
Where it's recruiting
Birmingham
La Mesa · West Hills
Winter Park
Chicago
Allentown
North Charleston
Salt Lake City
Source: ClinicalTrials.gov · NCT07219771 · last updated 2026-04-29