A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 3 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
Doron Therapeutics Inc.
Summary
This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis. The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to placebo over a 52-week period in participants with radiographic and symptomatic knee OA.
Description
The participants will be randomized in a 1:1 ratio to receive one of either PTP-001 or placebo injection. Each participant will be administered a single dose of investigational product (IP) (active or placebo) on Day 1. The trial will consist of a Screening period (up to 28 days prior to treatment), a treatment phase (1 day) and a follow-up phase (12 months following treatment). A total of at least 260 participants are planned to be randomized (130 participants/group).
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and females aged 40 to 80 years. 2. Presenting with symptomatic knee OA with Kellgren-Lawrence (KL) radiographic classification of 2 or 3 (mild or moderate), as assessed by the central reading facility. 3. Primary source of pain throughout the body is due to OA in the target knee. 4. Target knee pain ≥ 20 and ≤ 40 out of 50 on the WOMAC® numerical rating scale (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, failed response, or intol…
Interventions
- BiologicalPTP-01
Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.
- OtherPlacebo control / saline vehicle
The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.
Locations (17)
- Central Research Associates, LLC dba Flourish ResearchBirmingham, Alabama
- Horizon Clinical ResearchLa Mesa, California
- Focus Clinical ResearchWest Hills, California
- Conquest Research, LLCWinter Park, Florida
- Chicago Clinical Research Institute, Inc.Chicago, Illinois
- Lehigh Center for Clinical ResearchAllentown, Pennsylvania