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

Phase 1

• Conditions: Osteoarthritis of the knee; MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-003395-13-DK
• Lead Sponsor: Bioventus LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-26
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Male or female, aged 40 to 80 years
2. Symptomatic knee OA with Kellgren-Lawrence (KL) radiographic classification of 2, 3, or 4 (mild, moderate, or severe) as assessed by the central reading facility
3. IF KL radiographic classification of 4 (KL 4) is assessed by the central reading facility, participant must not have prior a referral from their treating physician for arthroplasty of the target knee
4. Target knee pain = 20 and = 40 out of 50 the WOMAC®NRS 3.1 pain questionnaire (sum of 5 questions) at screening and baseline
5. Onset of symptomatic OA of the target knee was at least 6 months prior to screening
6. Insufficient or failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs, as reported by the participant
7. 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
8. Willingness to remain on the same oral rescue” (as needed) analgesic as the only pharmacologic treatment for knee pain during the study
9. Willingness to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study
10. Written informed consent is obtained from the participant

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion Criteria

- 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) at screening or baseline
- 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
- Chronic use of narcotics or alcohol abuse within the past 6 months prior to screening
- 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
- Participant previously underwent arthroplasty of the target knee
13. Symptomatic OA of the non-target knee that is not responsive to paracetamol (acetaminophen) or oral nonsteroidal anti-inflammatory drugs (NSAIDs).
15. Osteonecrosis of either knee
16. Significant acute (within the past 3 months) injury to the target knee

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified