NCT05516992

Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety and Efficacy of SB-01 For Injection for the Treatment of Lumbar Degenerative Disc Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 417 (actual)
• Sponsor: Spine BioPharma, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.

Conditions

• Lumbar Degenerative Disc Disease

Interventions

Type	Name	Description
DRUG	SB-01 For Injection	Intradiscal injection
DRUG	Sham Needle	Sham needle placement

Timeline

• Start date: 2022-08-19
• Primary completion: 2025-03-21
• Completion: 2025-08-27
• First posted: 2022-08-26
• Last updated: 2025-06-10

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study