Actively Recruiting
A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients
Led by Doron Therapeutics Inc. · Updated on 2026-04-29
260
Participants Needed
17
Research Sites
102 weeks
Total Duration
On this page
Sponsors
D
Doron Therapeutics Inc.
Lead Sponsor
N
Novotech (Australia) Pty Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 40 to 80 years
- Symptomatic knee osteoarthritis with mild or moderate radiographic classification (Kellgren-Lawrence grade 2 or 3)
- Primary source of pain is due to osteoarthritis in the target knee
- Target knee pain score between 20 and 40 out of 50 on the WOMAC numerical rating scale at screening and baseline
- Onset of symptomatic osteoarthritis in the target knee at least 6 months prior to screening
- Insufficient response, intolerance, or failure of analgesics or non-steroidal anti-inflammatory drugs
- Females must not be breastfeeding, not planning pregnancy during the study, abstain from egg donation, have a negative pregnancy test within 72 hours before injection, and use effective birth control for at least 90 days after injection if of childbearing potential
- Willing to use acetaminophen as the only oral rescue medication for knee pain during the study
- Willing to avoid unauthorized or illicit medications for osteoarthritis or other conditions during the study
- Willing to comply with study visit schedule and post-injection restrictions
- Provide written informed consent
You will not qualify if you...
- Unable to walk more than 50 feet without assistance
- Body mass index of 40 kg/m2 or higher (clinically severe obesity)
- Contralateral knee pain score of 10 or higher out of 50 on the WOMAC scale at screening or baseline
- Difference of 3 or more between two baseline WOMAC pain scores for the target knee
- Contralateral knee pain lasting 14 or more days in the past month
- Use of any analgesics during the washout period at screening or baseline
- Participation in other investigational drug or device studies within 30 days prior to screening or planned participation within 30 days after study completion
- Use of lower extremity prosthesis or structural knee brace with hardware
- Significant knee effusion at screening or baseline unless resolved by aspiration
- Severe malalignment of the tibial-femoral axis on prior X-ray
- Active infection in the target knee or systemic infection requiring treatment within 3 months prior to screening
- Diagnosis of inflammatory arthritis such as rheumatoid arthritis or lupus
- Prior intra-articular injections of hyaluronic acid, corticosteroids, platelet-rich plasma, or stem cell therapy within defined timeframes before screening
- Chronic systemic corticosteroid use exceeding 10 mg prednisolone daily
- Treatment with immunosuppressive medication or chemotherapy within past 5 years
- Chronic narcotic use or alcohol abuse within past 6 months
- Surgery to either knee within 6 months before or planned within 6 months after injection
- Previous knee replacement surgery of the target knee
- Joint instability or symptoms suggesting internal knee derangement
- Diagnosis of gout or pseudo-gout within past 6 months
- History or current osteonecrosis of either knee
- Significant acute injury to the target knee within past 3 months
- History of organ or hematologic transplant
- History of malignancy, radiotherapy, or chemotherapy within past 5 years except certain skin cancers
- History of radiation therapy to the target knee
- Autoimmune diseases affecting the musculoskeletal system
- Known HIV or AIDS
- Other conditions causing knee pain that may interfere with assessments
- Other chronic pain requiring chronic analgesic use
- Any medical conditions or factors judged by the investigator to interfere with study participation
- Involvement in legal litigation related to a medical condition or injury
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Central Research Associates, LLC dba Flourish Research
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Horizon Clinical Research
La Mesa, California, United States, 91942
Actively Recruiting
3
Focus Clinical Research
West Hills, California, United States, 91307
Actively Recruiting
4
Conquest Research, LLC
Winter Park, Florida, United States, 32789
Actively Recruiting
5
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, United States, 60607
Actively Recruiting
6
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Actively Recruiting
7
Coastal Carolina Research Center, LLD
North Charleston, South Carolina, United States, 29405
Actively Recruiting
8
JBR Clinical Research, LLC
Salt Lake City, Utah, United States, 84107
Actively Recruiting
9
Emeritus Research Sydney
Botany, New South Wales, Australia, 2019
Actively Recruiting
10
Genesis Research Services
Broadmeadow, New South Wales, Australia, 2292
Actively Recruiting
11
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
12
University of the Sunshine Coast Clinical Trials, Birtinya
Birtinya, Queensland, Australia, 4575
Actively Recruiting
13
University of the Sunshine Coast Clinical Trials, Morayfield
Morayfield, Queensland, Australia, 4506
Actively Recruiting
14
University of the Sunshine Coast Clinical Trials, Noosa
Noosaville, Queensland, Australia, 4566
Actively Recruiting
15
Momentum Clinical Research Taringa
Taringa, Queensland, Australia, 4068
Actively Recruiting
16
Momentum Clinical Research Wellers Hill
Tarragindi, Queensland, Australia, 4121
Terminated
17
Momentum Clinical Research Sunshine
St Albans, Victoria, Australia, 3021
Actively Recruiting
Research Team
M
Mary Kathryn Kottke
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here