Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis

NCT ID: NCT05100225

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-11-30

Brief Summary

Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).

Detailed Description

This is 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. The study is planned to be conducted outside the United States. A total of approximately 210 participants are planned to be randomized to receive 1 of 2 doses of PTP-001 (100 mg or 200 mg) or saline vehicle control (placebo) injection. The purpose of the trial is to evaluate the efficacy, safety and tolerability of a single low dose and high dose of PTP-001 compared to placebo over a 26-week period.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PTP-001 200 mg

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

Group Type: EXPERIMENTAL

PTP-001

Intervention Type: BIOLOGICAL

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

PTP-001 100 mg

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

Group Type: EXPERIMENTAL

PTP-001

Intervention Type: BIOLOGICAL

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

Placebo/saline

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

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: OTHER

The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.

Interventions

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.

Intervention Type: BIOLOGICAL

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 Type: OTHER

Other Intervention Names

Physiological saline

Eligibility Criteria

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NBCD A/S

INDUSTRY

Sponsor Role: collaborator

Bioventus LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moin Khan, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University Department of Surgery St. Joseph's Healthcare Hamilton

Locations

Emeritus Research Sydney

Botany, New South Wales, Australia

Genesis Research Services

Broadmeadow, New South Wales, Australia

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Emeritus Research Melbourne

Camberwell, Victoria, Australia

Hamilton Medical Research Group

Hamilton, Ontario, Canada

McMaster University Department of Surgery St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Canadian Phase Onward Inc.

Toronto, Ontario, Canada

Diex Recherche Quebec Inc.

Québec, Quebec, Canada

Centrede Recherche Saint-Louis

Québec, Quebec, Canada

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Sanos Clinic Nordjylland

Gandrup, , Denmark

Sanos Clinic

Herlev, , Denmark

Sanos Clinic Syddanmark

Vejle, , Denmark

Countries

Australia; Canada; Denmark

References

Flannery CR, Seaman SA, Buddin KE, Nasert MA, Semler EJ, Kelley KL, Long M, Favret J, Pavesio A, Loeser RF. A novel placental tissue biologic, PTP-001, inhibits inflammatory and catabolic responses in vitro and prevents pain and cartilage degeneration in a rat model of osteoarthritis. Osteoarthritis Cartilage. 2021 Aug;29(8):1203-1212. doi: 10.1016/j.joca.2021.03.022. Epub 2021 May 20.

Reference Type: BACKGROUND

PMID: 34023528 (View on PubMed)

Other Identifiers

KOA-21-02

Identifier Type: -

Identifier Source: org_study_id