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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05100225




Registration number
NCT05100225
Ethics application status
Date submitted
19/10/2021
Date registered
29/10/2021

Titles & IDs
Public title
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
Scientific title
A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
Secondary ID [1] 0 0
KOA-21-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - PTP-001
Other interventions - Placebo control

Experimental: PTP-001 200 mg - A single intra-articular injection in the target knee of PTP-001 200 mg.

Experimental: PTP-001 100 mg - A single intra-articular injection in the target knee of PTP-001 100 mg.

Placebo comparator: Placebo/saline - A single intra-articular injection in the target knee of 4mL of placebo control - physiological saline (0.9% sodium chloride injection, USP).


Treatment: Other: PTP-001
Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.

Other interventions: Placebo control
The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy - Change from pretreatment baseline in the WOMAC pain subscale
Timepoint [1] 0 0
At 6 months
Primary outcome [2] 0 0
Safety - Incidence of local and systemic AEs
Timepoint [2] 0 0
Over 6 months
Secondary outcome [1] 0 0
Change from pretreatment baseline in pain intensity assessed by participant self report (WOMAC Pain subscale).
Timepoint [1] 0 0
At 2 weeks, 3 months, 4 months, 5 months.
Secondary outcome [2] 0 0
Change from pretreatment baseline in function assessed by participant self-report (WOMAC Function subscale).
Timepoint [2] 0 0
At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Secondary outcome [3] 0 0
Change from pretreatment baseline in the weekly average of daily pain assessed by patient self report (NRS).
Timepoint [3] 0 0
At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Secondary outcome [4] 0 0
Change from pretreatment baseline in patient global assessment of OA (PGA-OA) assessed by participant self report.
Timepoint [4] 0 0
At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Secondary outcome [5] 0 0
Change from pretreatment baseline in participant self-reported quality of life measured by SF-36 overall score, PCS, and MCS.
Timepoint [5] 0 0
At 3 months and 6 months.
Secondary outcome [6] 0 0
Response to PTP-001 on the OMERACT-OARSI responder criteria.
Timepoint [6] 0 0
At 2 weeks, 3 months, and 6 months.

Eligibility
Key inclusion criteria
* Participants are eligible to be included in the study only if all of the following criteria apply:

1. Male or female, aged 40 to 80 years
2. Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3 (mild or moderate) as assessed by the central reading facility
3. Target knee pain = 20 and = 40 out of 50 the WOMAC®NRS 3.1 pain questionnaire (sum of 5 questions) at screening and baseline
4. Onset of symptomatic OA of the target knee was at least 6 months prior to screening
5. Insufficient or failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs, as reported by the participant
6. IF FEMALE, must meet all of the following:

* Not breast feeding
* Not planning to become pregnant 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 (See Appendix A) for at least 12 weeks after the injection
7. Willingness to remain on the same oral "rescue" (as needed) analgesic as the only pharmacologic treatment for knee pain during the study
8. Willingness to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study
9. Written informed consent is obtained from the participant
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants are excluded from the study if any of the following criteria apply:

1. Participant is non-ambulatory (unable to walk >50 feet without assistance)
2. Clinically severe obesity as defined by the National Institutes of Health (body mass target =40 kg/m2)
3. Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC® NRS3.1 pain questionnaire) at screening and/or baseline
4. Clinically significant effusion of the target knee at either the screening or baseline visits determined by physical examination (e.g., 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.
5. Severe (excessive) malalignment of the tibial-femoral axis, assessed radiographically
6. Presence of active infection of the target knee or systemic infection requiring treatment within the 3 months prior to screening
7. Clinical diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology
8. Participant is receiving, has received, or plans to receive any of the following therapies

* Prior administration of hyaluronic acid, extended release corticosteroid (e.g., 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 intra-articular corticosteroid 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 10 mg prednisolone-equivalents 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 or chemotherapy within the past 5 years
9. Chronic use of narcotics or alcohol abuse within the past 6 months prior to screening
10. Surgery to the target knee (including arthroscopy) within 6 months prior to receiving the intra-articular injection or planned surgery to the target knee within 6 months after the injection
11. Participant previously underwent arthroplasty of the target knee
12. 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)
13. Symptomatic OA of the non-target knee that is not responsive to paracetamol (acetaminophen) or oral nonsteroidal anti-inflammatory drugs (NSAIDs).
14. Diagnosis of lower extremity gout or pseudo-gout in the past 6 months
15. Osteonecrosis of either knee
16. Significant acute (within the past 3 months) injury to the target knee
17. History of receiving a solid organ or hematologic transplant
18. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin
19. History of prior radiation therapy of the target knee
20. History of autoimmune disease affecting the musculoskeletal system
21. Known (documented) history of acquired immune deficiency syndrome or human immunodeficiency virus
22. Any condition causing pain in or around the target knee (e.g., radiating pain, pain in another region of the ipsilateral lower extremity) that may interfere with assessment(s) of the target knee
23. Other chronic pain anywhere in the body that requires the chronic use of analgesic medications, such as fibromyalgia, neuropathic pain, low back pain, etc.
24. Presence of contraindications for use of 3 g/day of orally administered paracetamol/acetaminophen due to known hypersensitivity or hepatic impairment.
25. Known presence of any concurrent medical condition (e.g., hematologic renal, hepatic, cardiac, or coagulation abnormalities) that in the investigator's judgment would interfere with the required study assessments and study participation
26. Participant is involved in litigation (e.g., worker's compensation) for a medical condition or injury at any anatomical site

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Emeritus Research Sydney - Botany
Recruitment hospital [2] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [4] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [5] 0 0
Emeritus Research Melbourne - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [3] 0 0
- Saint Leonards
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Denmark
State/province [3] 0 0
Gandrup
Country [4] 0 0
Denmark
State/province [4] 0 0
Herlev
Country [5] 0 0
Denmark
State/province [5] 0 0
Vejle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bioventus LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
NBCD A/S
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Moin Khan, MD
Address 0 0
McMaster University Department of Surgery St. Joseph's Healthcare Hamilton
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05100225