Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Lumbar Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT05516992

Run by

Spine BioPharma, Inc

People needed

417

Starts

2022-08-19

Expected to finish

2025-08-27

Last updated by the study team

2025-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows.
• Prior epidural, sacroiliac joint, and facet injections, or facet RFA (radiofrequency ablations) at any lumbosacral level within the past 4 weeks (e.g., transforaminal, interlaminar, caudal)
• Prior interventional procedures of other types at any lumbosacral level at any time (e.g., intradiscal injection, basivertebral nerve ablation, biacuplasty, spinal cord stimulator, others)
• Prior spine surgery at any lumbosacral level at any time (e.g., discectomy, decompression, instrumentation, fusion, fracture treatment, others)
• Prior fracture at any lumbar level
• Significant neurologic symptoms:
• Grade 3/5 or lower strength in any lumbar myotome
• Sensory deficit in a clearly radicular or sensory dermatome
• MRI evidence of disc height loss > 2/3 of adjacent disc at any level to be injected, determined by the independent radiologic central lab
• MRI evidence of other disc degeneration: Pfirrmann Grade 3-5 at any level not to be injected, determined by the independent radiologic central lab
• MRI evidence of disc herniation with neural compression at any level, determined by the independent radiologic central lab
• MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab
• MRI evidence of foraminal stenosis with neural compression at any level, determined by the independent radiologic central lab
• MRI evidence of moderate-to-severe facet arthrosis with edema at any level, determined by the independent radiologic central lab
• Spondylolisthesis (antero or retrolisthesis) > 25% at any level, determined by the independent radiologic central lab
• Lumbar coronal deformity, determined by the independent radiologic central lab:
• a. L1-S1 regional deformity > 25 degrees
• Spondylolysis at any level
• Lumbar inflammatory spondylitis
• Recent history (previous six months) of chemical or alcohol dependence
• Chronic narcotic use for more than defined as a daily dose of greater than 40 Morphine Equivalent Units (MEUs)
• Depression or Somatization defined through the Distress and Risk Assessment Method (DRAM) scoring with Zung score > 33 or Zung > 17 and the Modified Somatic Perception Questionnaire (MSPQ) score > 12
• Extreme obesity, defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
• A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 470 millisecond (msec)
• Active systemic infection

Where it is running

• Central Alabama Research — Birmingham, Alabama, United States
• Evolve Clinical Research — Phoenix, Arizona, United States
• Neurovations Research — Napa, California, United States
• Source Healthcare — Santa Monica, California, United States
• Science Connections, LLC — Doral, Florida, United States
• Coastal Clinical Research — Jacksonville, Florida, United States
• Conquest Research — Orlando, Florida, United States
• Conquest Research — Orlando, Florida, United States
• Pain Relief Centers — St. Petersburg, Florida, United States
• Tampa Pain Relief Center — Tampa, Florida, United States
• Florida Pain Relief Group — Tampa, Florida, United States
• Conquest Research — Winter Park, Florida, United States
• Vista Clinical Research, LLC — Newnan, Georgia, United States
• Injury Care Research — Boise, Idaho, United States
• The Orthopaedic Research Foundation, Inc (OrthoIndy) — Indianapolis, Indiana, United States
• Abay Neuroscience Center — Wichita, Kansas, United States
• OrthoNebraska — Omaha, Nebraska, United States
• Pioneer Clinical Research — New York, New York, United States
• Meta Medical Research Institute — Cincinnati, Ohio, United States
• META Medical Research Institute — Dayton, Ohio, United States
• The Orthopedic Center — Tulsa, Oklahoma, United States
• HD Research — Bellaire, Texas, United States
• NeuroCare Partners — Houston, Texas, United States
• South Texas Spinal Clinic — San Antonio, Texas, United States
• Precision Spine Care — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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