NCT06799845

Study Assessing Pain Relief After Replacement of the Knee

A Phase 2B, Randomized, Double Blind, Placebo and Active Comparator Controlled, Multicenter, Safety, and Efficacy Trial of ATX101 in Adults Undergoing Total Knee Arthroplasty

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Allay Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty. The study will compare the effectiveness of ATX101 with a saline placebo and bupivacaine, an active comparator. Additionally, it will assess opioid consumption among participants receiving ATX101 versus those given the saline placebo and bupivacaine. The trial will also focus on the safety and tolerability of ATX101 in the participants.

Conditions

• Total Knee Arthroplasty (Postoperative Pain)

Interventions

Type	Name	Description
DRUG	ATX101	ATX101 bupivacaine implants, total of 1,500 mg into the surgical site
DRUG	bupivacaine hydrochloride	bupivacaine hydrochloride 0.25% without epinephrine/adrenaline, total 125 mg in 50 mL via local periarticular infiltration
DRUG	saline placebo	normal saline (0.9%) sodium chloride, total volume of up to 17 mL via local periarticular infiltration

Timeline

• Start date: 2025-02-03
• Primary completion: 2025-10-03
• Completion: 2025-10-03
• First posted: 2025-01-29
• Last updated: 2025-11-04

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study