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Safety Study of PTP-001 for Treating Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Biological: PTP-001

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Use of immunosuppressive or chemotherapeutic agents within 5 years of Screening
Known allergy to local anesthetics or allograft tissues
Known history of hepatitis
Known history of thrombotic or thromboembolic phenomena.
Known history of primary or secondary immunodeficiency disorders
Presence of concurrent medical condition that, in the investigator's judgement, could compromise participant safety or interfere with the required study assessments and study participation.

Note: Other protocol defined inclusion/exclusion criteria apply.

Sites / Locations

James R. Urbaniak, MD, Duke Sports Science Institute
Coastal Carolina Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PTP-001 - Low Dose (100 mg)

PTP-001 - High Dose (200 mg)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Western Ontario and McMaster University (WOMAC) Pain Responder Rate

WOMAC Physical Function Responder Rate

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)

WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) is measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where higher score represents higher pain.

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)

WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) is measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where higher score represents higher pain.

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"

Change from baseline in health-related quality of life, by assessing the items from the Short Form 36 (SF-36) survey

The SF-36 measures 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health (the possible total normalized score ranges from 0-100). Higher scores on the SF-36 indicate better health status.

Full Information

NCT ID

NCT04632966

First Posted

November 5, 2020

Last Updated

December 8, 2021

Sponsor

Bioventus LLC

1. Study Identification

Unique Protocol Identification Number

NCT04632966

Brief Title

Safety Study of PTP-001 for Treating Knee Osteoarthritis

Official Title

A Prospective, Open-Label, Dose-Escalation Phase 1 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 26, 2021 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioventus LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 open-label, dose-escalation study is expected to enroll 20 participants, 40-80 years of age and test two doses (low and high dose) of PTP-001, an allogeneic placental tissue particulate, in two unique cohorts of 10 participants each. Each participant will receive a single intra-articular (IA) injection of PTP-001. Following the completion of the first cohort in which 10 participants (Kellgren-Lawrence Grade 2 or 3 knee OA) will be treated with the low dose of PTP-001, safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Open-label, dose-escalation

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PTP-001 - Low Dose (100 mg)

Arm Type

Experimental

Arm Description

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

Arm Title

PTP-001 - High Dose (200 mg)

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Biological: PTP-001

Intervention Description

allogeneic placental tissue particulate

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline to Week 52

Secondary Outcome Measure Information:

Title

Western Ontario and McMaster University (WOMAC) Pain Responder Rate

Time Frame

Week 26 and Week 52

Title

WOMAC Physical Function Responder Rate

Time Frame

Week 26 and Week 52

Title

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)

Description

Time Frame

Baseline to Week 52

Title

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)

Description

WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) is measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where higher score represents higher pain.

Time Frame

Baseline to Week 52

Title

Time Frame

Baseline to Week 52

Title

Change from baseline in health-related quality of life, by assessing the items from the Short Form 36 (SF-36) survey

Description

Time Frame

Baseline to Week 52

Other Pre-specified Outcome Measures:

Title

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

Description

Urinary CTX-II samples Serum PRO-C2 samples

Time Frame

Baseline to Week 52

Title

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

Time Frame

Baseline to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Use of immunosuppressive or chemotherapeutic agents within 5 years of Screening Known allergy to local anesthetics or allograft tissues Known history of hepatitis Known history of thrombotic or thromboembolic phenomena. Known history of primary or secondary immunodeficiency disorders Presence of concurrent medical condition that, in the investigator's judgement, could compromise participant safety or interfere with the required study assessments and study participation. Note: Other protocol defined inclusion/exclusion criteria apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annunziato Amendola, MD

Organizational Affiliation

James R. Urbaniak, MD, Duke Sports Science Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

James R. Urbaniak, MD, Duke Sports Science Institute

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Coastal Carolina Research Center

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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

Results Reference

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PubMed Identifier

34023528

Citation

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.

Results Reference

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Safety Study of PTP-001 for Treating Knee Osteoarthritis

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