A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee

Conditions

• Osteoarthritis (OA) of the Knee

Eligibility Criteria

Sex

ALL

Age

45 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Enekinragene Inzadenovec (PCRX-201) — BIOLOGICAL
  Enekinragene Inzadenovec (PCRX-201) injection
• Placebo — BIOLOGICAL
  Placebo injection

Study Details

The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn how the body reacts to the PCRX-201 injection and how effective the treatment is. Researchers will compare Dose A and Dose B of PCRX-201 versus placebo from Week 1 through Week 52 to assess adverse events. Researchers will also explore how PCRX-201 may impact knee pain and joint function over time. Participants will be asked to * Visit the clinic for pretreatment and drug administration * Visit the clinic for checkups and tests: 1. Screening through Week 52: intially weekly, bi-weekly, later monthly 2. Week 53 through Week 260 (Year 5): 8 visits throughout the period

Key Dates

First listed

Mar 19, 2025

Start date

Feb 26, 2025

Status verified

Aug 2026

Primary completion

Nov 30, 2026

Completion

Jul 31, 2032

Study Design

Enrollment

135 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A Dose A
  Single Intra-Articular injection
• Placebo Comparator: Part A, Placebo
  Single Intra-Articular injection
• Experimental: Part B Dose A
  Single Intra-Articular injection
• Experimental: Part B Dose B
  Single Intra-Articular injection
• Placebo Comparator: Part B Placebo
  Part B Placebo
• Experimental: Part A, Dose B
  Single Intra-Articular injection

Primary Outcome Measure

Incidence (number and percent) of treatment-emergent adverse events (TEAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52 [ Time Frame: Week 1 through Week 52. ]

Central Contacts

• Lisa Ramsay, MA
  973-451-4019
  [email protected]

Locations (40)

Find similar trials in Birmingham, AL

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