Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

Lumbar Degenerative Disc Disease Clinical Trial

— MODEL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516992
• Other study ID #: SB01-M001
• Status: Recruiting
• Phase: Phase 3
• Start date: August 19, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Spine BioPharma, Inc
• Contact: Pamela Zicker, NP
• Phone: 831-239-4115
• Email: pzicker[@]spinebiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, or facet injections 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; radiofrequency (RF) ablation, 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

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease
• Spinal Diseases

Intervention

Drug:
• SB-01 For Injection
Intradiscal injection
• Sham Needle
Sham needle placement

Locations

Country	Name	City	State
United States	HD Research	Bellaire	Texas
United States	Central Alabama Research	Birmingham	Alabama
United States	Injury Care Research	Boise	Idaho
United States	Montefiore Medical Center	Bronx	New York
United States	HD Research at Legent Orthopedic Hospital	Carrollton	Texas
United States	Pain Management Center, Brigham and Women's Hospital	Chestnut Hill	Massachusetts
United States	META Medical Research Institute	Dayton	Ohio
United States	Science Connections, LLC	Doral	Florida
United States	Clinical Investigations LLC	Edmond	Oklahoma
United States	NeuroCare Partners	Houston	Texas
United States	The Orthopaedic Research Foundation, Inc (OrthoIndy)	Indianapolis	Indiana
United States	Coastal Clinical Research	Jacksonville	Florida
United States	Kettering Health	Kettering	Ohio
United States	Neurovations Research	Napa	California
United States	Duly Health	Naperville	Illinois
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Pioneer Clinical Research	New York	New York
United States	Vista Clinical Research, LLC	Newnan	Georgia
United States	Southern California (SC) Spine and Sport Medical Associates, Inc.	Newport Beach	California
United States	OrthoNebraska	Omaha	Nebraska
United States	Conquest Research	Orlando	Florida
United States	Conquest Research	Orlando	Florida
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	Evolve Clinical Research	Phoenix	Arizona
United States	Virginia iSpine Physicians	Richmond	Virginia
United States	Pain Relief Centers	Saint Petersburg	Florida
United States	University of Utah	Salt Lake City	Utah
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	South Texas Spinal Clinic	San Antonio	Texas
United States	Pacific Research Institute	San Diego	California
United States	Scripps Health	San Diego	California
United States	Central Coast Neurological Surgery	San Luis Obispo	California
United States	Source Healthcare	Santa Monica	California
United States	Arizona Pain	Scottsdale	Arizona
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Florida Pain Relief Group	Tampa	Florida
United States	Tampa Pain Relief Center	Tampa	Florida
United States	The Orthopedic Center	Tulsa	Oklahoma
United States	Precision Spine Care	Tyler	Texas
United States	Gershon Pain Specialists	Virginia Beach	Virginia
United States	Tranquil Clinical Research	Webster	Texas
United States	Abay Neuroscience Center	Wichita	Kansas
United States	Conquest Research	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Spine BioPharma, Inc	MCRA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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