NCT06236308

TTAX03 for the Treatment of Lumbosacral Facet Joint Pain

A Randomized, Phase 1 Dose Finding Study of TTAX03 for the Treatment of Lumbosacral Facet Joint Pain

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioTissue Holdings, Inc · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a pilot study examining the safety and efficacy of a single intra-articular (IA) injection of TTAX03 per joint to relieve severe spinal facet joint (FJ) pain and improve function in subjects with facet joint pain (FJP) in the lumbosacral region. The design is randomized, double blinded, placebo controlled and dose-group sequential.

Detailed description

This is a Phase 1, randomized, placebo-controlled, double-blinded dose ranging study design with two dose escalation cohorts to be conducted at three sites in the USA. The primary objective is to examine the safety of FJ IA injections with the test article. The fundamental framework for the number of subjects and dose escalation decisions is modeled on the widely utilized phase 1 "3+3" dose escalation design. A second objective is to examine the efficacy of two doses of TTAX03. The efficacy null hypothesis (HO) is that one administration of TTAX03, introduced into each of two or four joints (at one or two levels) by IA injection, will have no more benefit with respect to pain relief and improved function than an equal volume of placebo (sterile saline). The alternate hypothesis (HA) is that TTAX03 will provide a clinically meaningful reduction in pain and improvement in function compared to placebo. An exploratory objective is to examine the potential benefit in terms of reduced need for narcotic pain relief, radiofrequency ablation, or surgical procedures for relief of LBP.

Conditions

• Facet Joint Pain

Interventions

Type	Name	Description
BIOLOGICAL	TTAX03 10mg	TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic techniques followed by terminal sterilization by gamma-irradiation in compliance with Current Good Tissue Practices (CGTP) and Current Good Manufacturing Practices (CGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells.
BIOLOGICAL	TTAX03 25mg	TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic techniques followed by terminal sterilization by gamma-irradiation in compliance with Current Good Tissue Practices (CGTP) and Current Good Manufacturing Practices (CGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells.
BIOLOGICAL	Placebo Comparator: Control Saline	2 mL Sterile, preservative free 0.9% NaCl

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-01-31
• Completion: 2025-03-04
• First posted: 2024-02-01
• Last updated: 2025-03-07

Regulatory

• FDA-regulated drug study