NCT04841512

Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis

A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Facet Joint Osteoarthritis Pain

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Xalud Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Preliminary safety and efficacy of XT-150 in the synovial capsule of osteoarthritic facet joints in the vertebra of the spine.

Detailed description

This is a Phase 1, safety and efficacy study of XT-150 in adult participants experiencing back pain due to inflammation of the facet joint osteoarthritis (FJOA) and who are eligible for intra-synovial glucocorticoid injection, or radiofrequency ablation of medial branches of the primary dorsal ramus of the exiting nerve root, which innervates the adjacent facet joints.

Conditions

• Osteoarthritis, Spine

Interventions

Type	Name	Description
BIOLOGICAL	XT-150	non-viral Plasmid DNA encoding an IL-10 variant transgene

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2021-04-12
• Last updated: 2022-03-17

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study