A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT07219771

Run by

Doron Therapeutics Inc.

People needed

260

Starts

2025-10-14

Expected to finish

2027-10-01

Last updated by the study team

2026-04-29

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,
• Not planning to become pregnant during the study,
• Must abstain from ova / egg donation during the study,
• If of childbearing potential, must have a negative pregnancy test result within 72 hours prior to receiving the intra-articular injection, and must commit to the use of a highly effective form of birth control for at least 90 days after the injection.
• Willing to use acetaminophen as the only oral rescue (as needed) analgesic medication for target knee pain during the study.
• Willing to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study.
• Willing to comply with study visit schedule and post-injection restrictions.
• Written informed consent is obtained from the participant.

You may not qualify if…

• 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.
• 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).
• Clinically significant effusion of the target knee at either the Screening or Baseline visits as determined by physical examination (eg, ballotable patella or positive bulge sign).
• Note: Participants presenting with effusion may be enrolled in the study after undergoing knee aspiration to remove excess fluid in the target joint.
• Severe (excessive) malalignment of the tibial-femoral axis assessed radiographically (by previous X-ray, rather than that performed for Kellgren-Lawrence assessment).
• Presence of active infection in the target knee or systemic infection requiring treatment within the 3 months prior to Screening.
• Clinical diagnosis of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology.
• Participant is receiving, has received, or plans to receive any of the following therapies:
• Prior administration of hyaluronic acid, extended-release corticosteroid (eg, Zilretta®), platelet-rich plasma (PRP), or stem cell therapies by intra-articular injection(s) of the target knee within 6 months prior to Screening.
• Prior administration of corticosteroid by intra-articular injection of the target knee within 3 months prior to Screening or into any other joint within 30 days prior to Screening.
• Current chronic systemic use of corticosteroids in doses exceeding the equivalent of 10 mg prednisolone daily.
• Treatment with any investigational therapy (drug, device, or biologic) within 3 months prior to Screening or is planned for the duration of the study.
• Treatment with immunosuppressive medication (not including mild transient immunosuppressants such as corticosteroids) or chemotherapy within the past 5 years.
• Chronic use of narcotics or alcohol abuse within the past 6 months prior to Screening.
• Surgery to either knee (including arthroscopy) within 6 months prior to receiving the intra-articular injection or planned surgery of either knee within 6 months after the injection.
• Participant previously underwent arthroplasty (ie, full or partial knee replacement) of the target knee.
• Presence of joint instability or complaints of locking, intermittent limitation in range of motion, or loose body sensation, suggestive of internal derangement of the knee (either extremity).
• Diagnosis of lower extremity gout or pseudo-gout in the past 6 months prior to Screening.
• History of, or current manifestation of, osteonecrosis of either knee.

Where it is running

• Momentum Clinical Research Sunshine — St Albans, Victoria, Australia (enrolling)
• Horizon Clinical Research — La Mesa, California, United States (enrolling)
• Focus Clinical Research — West Hills, California, United States (enrolling)
• Conquest Research, LLC — Winter Park, Florida, United States (enrolling)
• Chicago Clinical Research Institute, Inc. — Chicago, Illinois, United States (enrolling)
• Lehigh Center for Clinical Research — Allentown, Pennsylvania, United States (enrolling)
• Coastal Carolina Research Center, LLD — North Charleston, South Carolina, United States (enrolling)
• JBR Clinical Research, LLC — Salt Lake City, Utah, United States (enrolling)
• Emeritus Research Sydney — Botany, New South Wales, Australia (enrolling)
• Genesis Research Services — Broadmeadow, New South Wales, Australia (enrolling)
• Royal North Shore Hospital — St Leonards, New South Wales, Australia (enrolling)
• University of the Sunshine Coast Clinical Trials, Birtinya — Birtinya, Queensland, Australia (enrolling)
• University of the Sunshine Coast Clinical Trials, Morayfield — Morayfield, Queensland, Australia (enrolling)
• University of the Sunshine Coast Clinical Trials, Noosa — Noosaville, Queensland, Australia (enrolling)
• Momentum Clinical Research Taringa — Taringa, Queensland, Australia (enrolling)
• Central Research Associates, LLC dba Flourish Research — Birmingham, Alabama, United States (enrolling)
• Momentum Clinical Research Wellers Hill — Tarragindi, Queensland, Australia

Full record on ClinicalTrials.gov

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