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

April 28, 2026 updated by: Doron Therapeutics Inc.

A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 3 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The participants will be randomized in a 1:1 ratio to receive one of either PTP-001 or placebo injection. Each participant will be administered a single dose of investigational product (IP) (active or placebo) on Day 1.

The trial will consist of a Screening period (up to 28 days prior to treatment), a treatment phase (1 day) and a follow-up phase (12 months following treatment). A total of at least 260 participants are planned to be randomized (130 participants/group).

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Recruiting
        • Emeritus Research Sydney
        • Contact:
        • Principal Investigator:
          • Ronald Mak
      • Broadmeadow, New South Wales, Australia, 2292
        • Recruiting
        • Genesis Research Services
        • Principal Investigator:
          • Deon Smith
        • Contact:
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
        • Contact:
        • Principal Investigator:
          • Shirley Yu
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • University of the Sunshine Coast Clinical Trials, Birtinya
        • Principal Investigator:
          • Peter De Wet
        • Contact:
      • Morayfield, Queensland, Australia, 4506
        • Recruiting
        • University of the Sunshine Coast Clinical Trials, Morayfield
        • Contact:
        • Principal Investigator:
          • Indika Leelasena
      • Noosaville, Queensland, Australia, 4566
        • Recruiting
        • University of the Sunshine Coast Clinical Trials, Noosa
        • Principal Investigator:
          • Stephanie Wallace
        • Contact:
      • Taringa, Queensland, Australia, 4068
      • Tarragindi, Queensland, Australia, 4121
        • Terminated
        • Momentum Clinical Research Wellers Hill
    • Victoria
      • St Albans, Victoria, Australia, 3021
        • Recruiting
        • Momentum Clinical Research Sunshine
        • Principal Investigator:
          • Roy Rasalam
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
    • California
      • La Mesa, California, United States, 91942
        • Recruiting
        • Horizon Clinical Research
        • Principal Investigator:
          • Scott Hacker, MD
        • Contact:
      • West Hills, California, United States, 91307
    • Florida
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research, LLC
        • Contact:
        • Principal Investigator:
          • Aanand Patel, MD
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Chicago Clinical Research Institute, Inc.
        • Principal Investigator:
          • Dennis Levinson, MD
        • Contact:
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • Lehigh Center for Clinical Research
        • Contact:
        • Principal Investigator:
          • Jay Kalawadia, MD
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Recruiting
        • Coastal Carolina Research Center, LLD
        • Contact:
        • Principal Investigator:
          • Shailesh Patel, MD
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • JBR Clinical Research, LLC
        • Principal Investigator:
          • Todd Bertoch, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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,
    2. Not planning to become pregnant during the study,
    3. Must abstain from ova / egg donation during the study,
    4. 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.
  8. Willing to use acetaminophen as the only oral rescue (as needed) analgesic medication for target knee pain during the study.
  9. Willing to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study.
  10. Willing to comply with study visit schedule and post-injection restrictions.
  11. Written informed consent is obtained from the participant.

Exclusion Criteria:

  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).

  9. 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.

  10. Severe (excessive) malalignment of the tibial-femoral axis assessed radiographically (by previous X-ray, rather than that performed for Kellgren-Lawrence assessment).
  11. Presence of active infection in the target knee or systemic infection requiring treatment within the 3 months prior to Screening.
  12. Clinical diagnosis of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology.

  13. Participant is receiving, has received, or plans to receive any of the following therapies:

    1. 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.
    2. 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.
    3. Current chronic systemic use of corticosteroids in doses exceeding the equivalent of 10 mg prednisolone daily.
    4. Treatment with any investigational therapy (drug, device, or biologic) within 3 months prior to Screening or is planned for the duration of the study.
    5. Treatment with immunosuppressive medication (not including mild transient immunosuppressants such as corticosteroids) or chemotherapy within the past 5 years.
  14. Chronic use of narcotics or alcohol abuse within the past 6 months prior to Screening.
  15. 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.
  16. Participant previously underwent arthroplasty (ie, full or partial knee replacement) of the target knee.
  17. 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).
  18. Diagnosis of lower extremity gout or pseudo-gout in the past 6 months prior to Screening.
  19. History of, or current manifestation of, osteonecrosis of either knee.
  20. Significant acute (within the past 3 months) injury to the target knee.
  21. History of receiving a solid organ or hematologic transplant.
  22. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin.
  23. History of prior radiation therapy of the target knee.
  24. History of autoimmune disease affecting the musculoskeletal system.
  25. Known (documented) history of acquired immune deficiency syndrome or human immunodeficiency virus (HIV).
  26. Any condition causing pain in or around the target knee (eg, radiating pain or pain in another region of the ipsilateral lower extremity) that may interfere with assessment(s) of the target knee.
  27. Other chronic pain anywhere in the body that requires the chronic use of analgesic medications, such as knee OA of the contralateral (non-target) knee, fibromyalgia, tendonitis, plantar fasciitis, neuropathic pain, lower back pain, etc.
  28. Known presence of any concurrent medical condition (eg, hematologic renal, hepatic, cardiac, or coagulation abnormalities) or other factors that in the Investigator's judgment would interfere with the required study assessments and study participation.
  29. Participant is involved in litigation (eg, worker's compensation) for a medical condition or injury at any anatomical site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PTP-001 200 mg
A single intra-articular injection in the target knee of PTP-001 200 mg
Biological: PTP-01
Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.
Other Names:
  • MOTYS™
  • allogeneic human placental tissue particulate
Placebo Comparator: Placebo / saline vehicle
A single intra-articular injection in the target knee of 4 mL of placebo control (0.9% sodium chloride injection, USP)
Other: Placebo control / saline vehicle
The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.
Other Names:
  • Normal saline
  • Physiological saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants meeting strict responder criteria for improvement in knee function.
Time Frame: 6 months
To qualify as a "strict responder for improvement in knee function", an improvement of ≥ 50% in WOMAC Function subscale score is required, with an absolute change ≥ 20 points in the score.
6 months
Proportion of participants meeting strict responder criteria for improvement in knee pain.
Time Frame: 6 months
To qualify as a "strict responder for improvement in knee pain", an improvement of ≥ 50% in WOMAC Pain subscale score is required, with an absolute change ≥ 20 points in the score.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants meeting strict responder criteria for improvement in knee function.
Time Frame: 9 months and 12 months
9 months and 12 months
Proportion of participants meeting strict responder criteria for improvement in knee pain.
Time Frame: 9 months and 12 months
9 months and 12 months
Change from pretreatment Baseline in participant self-reported assessment of OA by PGA-OA score.
Time Frame: 6 months, 9 months, and 12 months
6 months, 9 months, and 12 months
Change from pretreatment Baseline in participant self-reported function of the treated knee as assessed by WOMAC Function subscale score.
Time Frame: 6 months, 9 months, and 12 months
6 months, 9 months, and 12 months
Change from pretreatment Baseline in participant self-reported pain at the treated knee as assessed by WOMAC Pain subscale score.
Time Frame: 6 months, 9 months, and 12 months
6 months, 9 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Doron Therapeutics Inc.

Collaborators

Novotech (Australia) Pty Limited

Investigators

  • Principal Investigator: Professor David Hunter, Chair of Rheumatology at University of Sydney and Royal North Shore Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 21, 2025

First Submitted That Met QC Criteria

October 21, 2025

First Posted (Actual)

October 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOA-25-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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