Clinical trial NCT05516992: Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Lumbar Degenerative Disc Disease
Lead sponsor: Spine BioPharma, Inc
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2022-08-26
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Back pain greater than 'worst leg pain' as measured by the NRS
3. 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
4. Have chronic low back pain and related disability for at least 6 months with at least 3 months of prior conservative treatment
5. Baseline ODI score ≥ 40/100
6. Baseline NRS ≥ 4 points (Back)
7. Willing and able to provide Informed Consent for study participation
8. Willing and able to comply with this protocol and be available for the entire duration of the study, including ability to access the internet
9. Must practice effective contraception during the first 3 months of follow-up (female of childbearing potential and male subjects):

   1. Abstinence or,
   2. Surgical Sterilization or,
   3. Oral Contraceptives or,
   4. Barrier Methods (Condoms, IUD's).
10. Patient must verify that:

    1. In the case of females, the patient is post-menopausal or is surgically sterile or,
    2. In the case of males, the patient is surgically sterile or,
    3. 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.

1. 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)
2. 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)
3. Prior spine surgery at any lumbosacral level at any time (e.g., discectomy, decompression, instrumentation, fusion, fracture treatment, others)
4. Prior fracture at any lumbar level
5. Significant neurologic symptoms:

   1. Grade 3/5 or lower strength in any lumbar myotome
   2. Sensory deficit in a clearly radicular or sensory dermatome
6. MRI evidence of disc height loss \> 2/3 of adjacent disc at any level to be injected, determined by the independent radiologic central lab
7. MRI evidence of other disc degeneration: Pfirrmann Grade 3-5 at any level not to be injected, determined by the independent radiologic central lab
8. MRI evidence of disc herniation with neural compression at any level, determined by the independent radiologic central lab
9. MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab
10. MRI evidence of foraminal stenosis with neural compression at any level, determined by the independent radiologic central lab
11. MRI evidence of moderate-to-severe facet arthrosis with edema at any level, determined by the independent radiologic central lab
12. Spondylolisthesis (antero or retrolisthesis) \> 25% at any level, determined by the independent radiologic central lab
13. Lumbar coronal deformity, determined by the independent radiologic central lab:

    a. L1-S1 regional deformity \> 25 degrees
14. Spondylolysis at any level
15. Lumbar inflammatory spondylitis
16. Recent history (previous six months) of chemical or alcohol dependence
17. Chronic narcotic use for more than defined as a daily dose of greater than 40 Morphine Equivalent Units (MEUs)
18. 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
19. Extreme obesity, defined by NIH Clinical Guidelines Body Mass Index (BMI \> 40)
20. A QT duration corrected for heart rate by Fridericia's formula (QTcF) \> 470 millisecond (msec)
21. Active systemic infection
22. Infection at the site of procedure pre-operatively
23. Cauda equina syndrome or neurogenic bowel/bladder dysfunction
24. 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
25. Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease)
26. Any disease, condition or surgery which might impair healing, such as:

    1. Active malignancy
    2. History of metastatic malignancy
27. 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
28. Any planned surgical procedure within the subject participation period (screening through the 12 Month Visit)
29. Any clinically relevant laboratory result on the screening visit Chem-12, hematology, or coagulation panels
30. Pregnancy at the time of screening, randomization, or planning to become pregnant during the first 3 months of follow-up
31. Currently a prisoner
32. Participation in any other investigational drug, biologic, or medical device study within the last 6 months prior to study procedure
33. Receiving Work Compensation benefits or engaged in personal spinal injury medical/legal litigation
34. Patient cannot be currently using the prohibited medications listed in the protocol

Primary outcomes:
measure: Change from Baseline in function on the Oswestry Disability Index (ODI) at 6 months.
timeFrame: Baseline/Screening and 6 Month
Secondary outcomes:
measure: 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.
timeFrame: Baseline/Screening and 6 Month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Phoenix
country: United States
facility: Evolve Clinical Research
state: Arizona
city: Napa
country: United States
facility: Neurovations Research
state: California
city: Santa Monica
country: United States
facility: Source Healthcare
state: California
city: Doral
country: United States
facility: Science Connections, LLC
state: Florida
city: Jacksonville
country: United States
facility: Coastal Clinical Research
state: Florida
city: Orlando
country: United States
facility: Conquest Research
state: Florida
city: Orlando
country: United States
facility: Conquest Research
state: Florida
city: St. Petersburg
country: United States
facility: Pain Relief Centers
state: Florida
city: Tampa
country: United States
facility: Tampa Pain Relief Center
state: Florida
city: Tampa
country: United States
facility: Florida Pain Relief Group
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Newnan
country: United States
facility: Vista Clinical Research, LLC
state: Georgia
city: Boise
country: United States
facility: Injury Care Research
state: Idaho
city: Indianapolis
country: United States
facility: The Orthopaedic Research Foundation, Inc (OrthoIndy)
state: Indiana
city: Wichita
country: United States
facility: Abay Neuroscience Center
state: Kansas
city: Omaha
country: United States
facility: OrthoNebraska
state: Nebraska
city: New York
country: United States
facility: Pioneer Clinical Research
state: New York
city: Cincinnati
country: United States
facility: Meta Medical Research Institute
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute
state: Ohio
city: Tulsa
country: United States
facility: The Orthopedic Center
state: Oklahoma
city: Bellaire
country: United States
facility: HD Research
state: Texas
city: Houston
country: United States
facility: NeuroCare Partners
state: Texas
city: San Antonio
country: United States
facility: South Texas Spinal Clinic
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia iSpine Physicians
state: Virginia
city: Virginia Beach
country: United States
facility: Gershon Pain Specialists
state: Virginia
Study officials:
affiliation: Brigham and Women's Spine Center
name: Christopher Gilligan, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: