Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine (MODEL)

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Degenerative Disc Disease
• Intervention / Treatment: Drug: SB-01 For Injection; Drug: Sham Needle

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pamela Zicker, NP; Phone Number: 831-239-4115; Email: pzicker@spinebiopharma.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Recruiting
      • Evolve Clinical Research
      • Contact: Lucia Rodriguez
      • Principal Investigator: Zeeshan Malik, MD
    • Scottsdale, Arizona, United States, 85258
      • Withdrawn
      • Arizona Pain
  • California
    • Napa, California, United States, 94558
      • Recruiting
      • Neurovations Research
      • Contact: Luana Leal
      • Principal Investigator: Eric Grigsby, MD
    • Newport Beach, California, United States, 92660-7641
      • Withdrawn
      • Southern California (SC) Spine and Sport Medical Associates, Inc.
    • San Diego, California, United States, 92121
      • Recruiting
      • Scripps Health
      • Contact: Joy Biggers
      • Principal Investigator: Kevin Barrette, MD
    • San Luis Obispo, California, United States, 93401
      • Recruiting
      • Central Coast Neurological Surgery
      • Contact: Dee Tran
      • Principal Investigator: David Yeh, MD
    • Santa Monica, California, United States, 90403
      • Recruiting
      • Source Healthcare
      • Contact: Terry Nguyen
      • Principal Investigator: Timothy Davis, MD
  • Florida
    • Doral, Florida, United States, 33178
      • Recruiting
      • Science Connections, LLC
      • Contact: Maria Olivera
      • Principal Investigator: Santiago Figuereo, MD
    • Jacksonville, Florida, United States, 32205
      • Recruiting
      • Coastal Clinical Research
      • Contact: Lew Whiting
      • Principal Investigator: Christopher Netzel, MD
    • Orlando, Florida, United States, 32804
      • Recruiting
      • Conquest Research
      • Contact: Emily Conte
      • Principal Investigator: Ravi Gandhi, MD
    • Saint Petersburg, Florida, United States, 33709
      • Recruiting
      • Pain Relief Centers
      • Contact: Shellie Reader
      • Principal Investigator: Robert Guirguis, MD
    • Tampa, Florida, United States, 33603
      • Recruiting
      • Tampa Pain Relief Center
      • Contact: Emily Wood
      • Principal Investigator: Jose Rivera, MD
    • Tampa, Florida, United States, 33614
      • Recruiting
      • Florida Pain Relief Group
      • Contact: Yiset Sanchez
      • Principal Investigator: Jorge Leal, MD
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Conquest Research
      • Contact: Emily Conte
      • Principal Investigator: Malisa Agard, MD
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Recruiting
      • Vista Clinical Research, LLC
      • Contact: Debra Helton
      • Principal Investigator: Ashley Miller, NP
  • Idaho
    • Boise, Idaho, United States, 83713
      • Recruiting
      • Injury Care Research
      • Principal Investigator: Richard Radnovich, DO
      • Contact: Jill Heinz
  • Illinois
    • Naperville, Illinois, United States, 60540
      • Recruiting
      • Duly Health
      • Principal Investigator: Ashish Patel, MD
      • Contact: Diego Carrington
  • Indiana
    • Indianapolis, Indiana, United States, 46278
      • Recruiting
      • The Orthopaedic Research Foundation, Inc (OrthoIndy)
      • Contact: Melanie Glover
      • Principal Investigator: Meredith Langhorst, MD
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Recruiting
      • Abay Neuroscience Center
      • Contact: Ariel Welty
      • Principal Investigator: Raymond Grundmeyer III, MD
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Withdrawn
      • Four Rivers Clinical Research
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Recruiting
      • Spine Institute of Louisiana
      • Contact: Brandi Casey
      • Principal Investigator: Matthew Mosura, MD
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Recruiting
      • Pain Management Center, Brigham and Women's Hospital
      • Contact: Kathryn Satko, MA
      • Principal Investigator: Robert Jason Yong, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Recruiting
      • OrthoNebraska
      • Contact: Elizabeth Olan
      • Principal Investigator: Joshua Urban, MD
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Aureliana Toma
      • Principal Investigator: Seon Kyu Lee, MD, PhD
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Reade De Leacy, MD
      • Contact: Colton Smith
    • New York, New York, United States, 10022
      • Recruiting
      • Ainsworth Institute Of Pain Management
      • Contact: Zoey Smith
      • Principal Investigator: Corey Hunter, MD
  • Ohio
    • Dayton, Ohio, United States, 45432
      • Recruiting
      • META Medical Research Institute
      • Principal Investigator: Priyesh Mehta, DO
      • Contact: Benu Kulkarni
    • Kettering, Ohio, United States, 45429
      • Recruiting
      • Kettering Health
      • Contact: Lucy Mekonnen
      • Principal Investigator: Mark Hoeprich, MD
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Withdrawn
      • Clinical Investigations LLC
    • Tulsa, Oklahoma, United States, 74104
      • Recruiting
      • The Orthopedic Center
      • Contact: Jessica Good
      • Principal Investigator: Brian Chalkin, DO
  • Texas
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • HD Research
      • Principal Investigator: Daneshvari Solanki, MD
      • Contact: Tina Troy
    • Houston, Texas, United States, 77008
      • Recruiting
      • NeuroCare Partners
      • Contact: Danielle Sewall
      • Principal Investigator: Amie Sun-Wright, MD
    • San Antonio, Texas, United States, 78240
      • Recruiting
      • South Texas Spinal Clinic
      • Contact: Paula Umstead
      • Principal Investigator: Paul Geibel, MD
    • Tyler, Texas, United States, 75701
      • Recruiting
      • Precision Spine Care
      • Principal Investigator: Aaron Calodney, MD
      • Contact: Jeanetta Patterson
    • Webster, Texas, United States, 77598
      • Recruiting
      • Tranquil Clinical Research
      • Contact: James Hamilton
      • Principal Investigator: Nedal Adi, MD
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University of Utah
      • Principal Investigator: Zachary McCormick, MD
      • Contact: Erica Duenes
    • Salt Lake City, Utah, United States, 84107
      • Recruiting
      • Wasatch Clinical Research
      • Contact: Annie Hanks
      • Principal Investigator: Albert Jarvi, MD
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Recruiting
      • Virginia iSpine Physicians
      • Principal Investigator: Michael DePalma, MD
      • Contact: Devon Withers
    • Virginia Beach, Virginia, United States, 23454
      • Recruiting
      • Gershon Pain Specialists
      • Contact: Erika Dorrman
      • Principal Investigator: Steven Gershon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spine BioPharma, Inc
• Collaborators: MCRA
• Investigators: Principal Investigator: Christopher Gilligan, MD, MBA, Brigham and Women's Spine Center

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: SB01-M001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No