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
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.
• 18 years of age or older
• Back pain greater than 'worst leg pain' as measured by the NRS
• Diagnosed with one or two contiguous level(s) lumbar (L1-S1) disc degeneration of Pfirrmann Grade 3 and/or 4 determined by MRI analyzed by the independent radiologic central lab
• Have chronic low back pain and related disability for at least 6 months with at least 3 months of prior conservative treatment
• Baseline ODI score ≥ 40/100
• Baseline NRS ≥ 4 points (Back)
• Willing and able to provide Informed Consent for study participation
• Willing and able to comply with this protocol and be available for the entire duration of the study, including ability to access the internet
• Must practice effective contraception during the first 3 months of follow-up (female of childbearing potential and male subjects):
∙ Abstinence or,
‣ Surgical Sterilization or,
‣ Oral Contraceptives or,
‣ Barrier Methods (Condoms, IUD's).
⁃ Patient must verify that:
• In the case of females, the patient is post-menopausal or is surgically sterile or,
∙ In the case of males, the patient is surgically sterile or,
∙ The patient (male or female) confirms that they are at a point in their life where they are beyond consideration of having children.