Safety Study of PTP-001 for Treating Knee Osteoarthritis

NCT04632966 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: KOA-20-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels

  Incidence of local and systemic treatment emergent adverse events (AEs), including clinical laboratory and immunogenicity panels, after a single intra-articular injection of PTP-001.

  Baseline to Week 52

Secondary Outcomes (6)

• Western Ontario and McMaster University (WOMAC) Pain Responder Rate

  Week 26 and Week 52

• WOMAC Physical Function Responder Rate

  Week 26 and Week 52

• Change from baseline in pain of the index knee, by evaluating the WOMAC Pain subscale score (the possible total score ranging from 0-50 for pain)

  Baseline to Week 52

• Change from baseline in physical function of the index knee, by evaluating the WOMAC Physical Function subscale score (the possible total score ranging from 0-170 for Physical Function)

  Baseline to Week 52

• Change from baseline in patient global assessment of OA, by assessing the participants assessment of how they are doing considering arthritis in index knee (the possible answers include "Very Good", "Good", "Acceptable", "Poor", "Very Poor"

  Baseline to Week 52

Other Outcomes (2)

• Change from baseline in biochemical markers (CTX-II & PRO-C2)

  Baseline to Week 52

• Change from baseline in joint space width of the index knee, assessed radiographically (OARSI radiographic scoring)

  Baseline to Week 52

Study Arms (2)

PTP-001 - Low Dose (100 mg)

EXPERIMENTAL

intra-articular injection of 100 mg PTP-001 resuspended with 4 mL of normal saline

Biological: Biological: PTP-001

PTP-001 - High Dose (200 mg)

EXPERIMENTAL

intra-articular injection of 200 mg PTP-001 resuspended with 4 mL of normal saline

Biological: Biological: PTP-001

Interventions

Biological: PTP-001 BIOLOGICAL

allogeneic placental tissue particulate

PTP-001 - High Dose (200 mg); PTP-001 - Low Dose (100 mg)

Eligibility Criteria

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

You may qualify if:

• Written consent to participate in the study
• Male or female, aged 40 to 80 years
• Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3
• Non-responsive after at least 3 months of conservative therapy for knee OA
• Females of childbearing potential must have negative pregnancy test result prior to treatment and must commit to highly effective methods of contraception for at least 6 months after treatment
• Willingness to report oral analgesic treatment used for knee pain and to discontinue analgesic treatment for knee pain in 24 hours prior to each study visit
• Willingness to limit use of pain rescue medication to oral acetaminophen for management of painful knee OA flare

You may not qualify if:

• Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with condition that warrants weight loss surgery
• Presence of active infection of index knee or systemic infection requiring treatment within 3 months of Screening
• Administration of IA injection within 3 months of Screening
• Significant acute injury to index knee within 3 months of Screening
• Surgery to index knee within 6 months of Screening or planned surgery to index knee within 6 months after Screening
• Unstable index knee joint
• History of radiation therapy of index knee
• Known vascular or neurological disorder affecting the index knee
• Osteonecrosis of either knee
• Clinical diagnosis of inflammatory arthritis
• Clinical diagnosis of autoimmune disease affecting the musculoskeletal system
• Use of any other investigational therapy within 3 months of Screening or planned for the duration of the study
• Current anti-coagulant use
• History of receiving a solid organ or hematologic transplant
• History of malignancy or radiotherapy within 5 years of Screening, except for basal or squamous cell carcinoma of the skin

Sponsors & Collaborators

• Bioventus LLC: lead

Study Sites (2)

James R. Urbaniak, MD, Duke Sports Science Institute

Durham, North Carolina, 27705, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29406, United States

Location

Related Publications (2)

• Flannery CR, Seaman SA, Buddin KE, et al. Characterization and preclinical efficacy of PTP-001, a novel human tissue biologic in development for the treatment of OA. Osteoarthritis Cartilage. 2020 Apr;28(Supplement 1):S487-S489. doi: 10.1016/j.joca.2020.02.763

  BACKGROUND

• 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

• Annunziato Amendola, MD

  James R. Urbaniak, MD, Duke Sports Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, dose-escalation

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 17, 2020
• Study Start: February 26, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)