clinical trial · NCT05516992
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
Spine BioPharma, Inc·phase3·active not recruiting·n = 417
Lumbar Degenerative Disc DiseaseSB-01 For InjectionSham Needle
brief 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.
started
Aug 19, 2022
primary completion
Mar 21, 2025
completion
Aug 27, 2025
last updated
Jun 10, 2025
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol