Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lumbar Degenerative Disc Disease

Intervention / Treatment
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* Drug: SB-01 For Injection
* Drug: Sham Needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows. Prior epidural, sacroiliac joint, or facet injections 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; radiofrequency (RF) ablation, 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 Infection at the site of procedure pre-operatively Cauda equina syndrome or neurogenic bowel/bladder dysfunction Any terminal, systemic, or autoimmune disease including fibromyalgia, which may, in the opinion of the Principal Investigator compromise a subject's ability to comply with study procedures, and/or confound data Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease) Any disease, condition or surgery which might impair healing, such as: Active malignancy History of metastatic malignancy Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin Any planned surgical procedure within the subject participation period (screening through the 12 Month Visit) Any clinically relevant laboratory result on the screening visit Chem-12, hematology, or coagulation panels Pregnancy at the time of screening, randomization, or planning to become pregnant during the first 3 months of follow-up Currently a prisoner Participation in any other investigational drug, biologic, or medical device study within the last 6 months prior to study procedure Receiving Work Compensation benefits or engaged in personal spinal injury medical/legal litigation Patient cannot be currently using the prohibited medications listed in the protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB-01 For Injection<br>Subjects receive a SB-01 For Injection intradiscal injection per treated disc. | Drug: SB-01 For Injection<br>* Intradiscal injection<br>|
| Placebo Comparator: Sham Needle<br>Subjects receive a sham needle placement for each treated disc. | Drug: Sham Needle<br>* Sham needle placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in function on the Oswestry Disability Index (ODI) at 6 months. | The ODI is a validated, 10-item self-reported instrument assessment of pain-related disability. Possible scores range from 0 (no disability) - 50 (severe disability). Further calculations are applied to reach a percentage score. | Baseline/Screening and 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in pain on the Numerical Rating Scale (NRS) at 6 months. This outcome will only be tested if the primary endpoint is met. | The NRS is an 11-point scale, self-reported instrument assessment of pain intensity ranging across a continuum from no pain to an extreme amount of pain. The NRS will be collected for: Back and both legs. A lower score indicates less pain. | Baseline/Screening and 6 Month |