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

NCT05100225 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: KOA-21-02
• Study Type: interventional
• Target: 210
• Locations: 3 countries
• Sites: 14

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).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• Efficacy - Change from pretreatment baseline in the WOMAC pain subscale

  To evaluate the change from pretreatment baseline in the WOMAC pain sub-score in the target knee on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized on scales of 0-100.

  At 6 months

• Safety - Incidence of local and systemic AEs

  To assess the long-term (6 months) incidence of local and systemic AEs, and consists of physical examination, laboratory values, AEs, AESI, and immunogenicity testing.

  Over 6 months

Secondary Outcomes (6)

• Change from pretreatment baseline in pain intensity assessed by participant self report (WOMAC Pain subscale).

  At 2 weeks, 3 months, 4 months, 5 months.

• Change from pretreatment baseline in function assessed by participant self-report (WOMAC Function subscale).

  At 2 weeks, 3 months, 4 months, 5 months, and 6 months.

• Change from pretreatment baseline in the weekly average of daily pain assessed by patient self report (NRS).

  At 2 weeks, 3 months, 4 months, 5 months, and 6 months.

• Change from pretreatment baseline in patient global assessment of OA (PGA-OA) assessed by participant self report.

  At 2 weeks, 3 months, 4 months, 5 months, and 6 months.

• Change from pretreatment baseline in participant self-reported quality of life measured by SF-36 overall score, PCS, and MCS.

  At 3 months and 6 months.

Study Arms (3)

PTP-001 200 mg

EXPERIMENTAL

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

Biological: PTP-001

PTP-001 100 mg

EXPERIMENTAL

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

Biological: PTP-001

Placebo/saline

PLACEBO COMPARATOR

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

Other: Placebo control

Interventions

PTP-001 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; PTP-001 200 mg

Placebo control OTHER

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

Also known as: Physiological saline

Placebo/saline

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Male or female, aged 40 to 80 years
• Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3 (mild or moderate) as assessed by the central reading facility
• Target knee pain ≥ 20 and ≤ 40 out of 50 the WOMAC®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 or failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs, as reported by the participant
• 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
• Willingness to remain on the same oral "rescue" (as needed) analgesic as the only pharmacologic treatment for knee pain during the study
• Willingness to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study
• Written informed consent is obtained from the participant

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Participant is non-ambulatory (unable to walk \>50 feet without assistance)
• Clinically severe obesity as defined by the National Institutes of Health (body mass target ≥40 kg/m2)
• 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
• 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.
• Severe (excessive) malalignment of the tibial-femoral axis, assessed radiographically
• Presence of active infection of the target knee or systemic infection requiring treatment within the 3 months prior to screening
• Clinical diagnosis of inflammatory arthritis (e.g., 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 (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
• Chronic use of narcotics or alcohol abuse within the past 6 months prior to screening

Sponsors & Collaborators

• Bioventus LLC: lead
• NBCD A/S: collaborator

Study Sites (14)

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

Location

Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia

Location

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Emeritus Research Melbourne

Camberwell, Victoria, 3124, Australia

Location

Hamilton Medical Research Group

Hamilton, Ontario, L8M 1K7, Canada

Location

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

Hamilton, Ontario, L8N 4A6, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3J 0K2, Canada

Location

Diex Recherche Quebec Inc.

Québec, Quebec, G1N4V3, Canada

Location

Centrede Recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Sanos Clinic Nordjylland

Gandrup, 9362, Denmark

Location

Sanos Clinic

Herlev, 2730, Denmark

Location

Sanos Clinic Syddanmark

Vejle, 7100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34023528 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Moin Khan, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blinded trial, in which neither participant nor investigator will know the content of the investigational product. Additionally, the study staff preparing the syringe. The unblinded personnel must not be involved in any other operational aspects of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: September 30, 2021
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6); DK (3); AU (5)