Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

NCT05516992 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: SB01-M001
• Study Type: interventional
• Target: 417
• Locations: 1 country
• Sites: 30

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.

Conditions

Lumbar Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  Baseline/Screening and 6 Month

Study Arms (2)

SB-01 For Injection

EXPERIMENTAL

Subjects receive a SB-01 For Injection intradiscal injection per treated disc.

Drug: SB-01 For Injection

Sham Needle

PLACEBO COMPARATOR

Subjects receive a sham needle placement for each treated disc.

Drug: Sham Needle

Interventions

SB-01 For Injection DRUG

Intradiscal injection

SB-01 For Injection

Sham Needle DRUG

Sham needle placement

Sham Needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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:

Sponsors & Collaborators

• Spine BioPharma, Inc: lead
• MCRA: collaborator

Study Sites (30)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Evolve Clinical Research

Phoenix, Arizona, 85013, United States

Location

Neurovations Research

Napa, California, 94558, United States

Location

Source Healthcare

Santa Monica, California, 90403, United States

Location

Science Connections, LLC

Doral, Florida, 33178, United States

Location

Coastal Clinical Research

Jacksonville, Florida, 32205, United States

Location

Conquest Research

Orlando, Florida, 32804, United States

Location

Conquest Research

Orlando, Florida, 32832, United States

Location

Pain Relief Centers

St. Petersburg, Florida, 33709, United States

Location

Tampa Pain Relief Center

Tampa, Florida, 33603, United States

Location

Florida Pain Relief Group

Tampa, Florida, 33614, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Vista Clinical Research, LLC

Newnan, Georgia, 30265, United States

Location

Injury Care Research

Boise, Idaho, 83713, United States

Location

The Orthopaedic Research Foundation, Inc (OrthoIndy)

Indianapolis, Indiana, 46278, United States

Location

Abay Neuroscience Center

Wichita, Kansas, 67226, United States

Location

OrthoNebraska

Omaha, Nebraska, 68144, United States

Location

Pioneer Clinical Research

New York, New York, 10016, United States

Location

Meta Medical Research Institute

Cincinnati, Ohio, 45069, United States

Location

META Medical Research Institute

Dayton, Ohio, 45432, United States

Location

The Orthopedic Center

Tulsa, Oklahoma, 74104, United States

Location

HD Research

Bellaire, Texas, 77401, United States

Location

NeuroCare Partners

Houston, Texas, 77008, United States

Location

South Texas Spinal Clinic

San Antonio, Texas, 78240, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

Tranquil Clinical Research

Webster, Texas, 77598, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Virginia iSpine Physicians

Richmond, Virginia, 23235, United States

Location

Gershon Pain Specialists

Virginia Beach, Virginia, 23454, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Injections

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Christopher Gilligan, MD, MBA

  Brigham and Women's Spine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind, placebo-controlled study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: August 19, 2022
• Primary Completion: March 21, 2025
• Study Completion: August 27, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

US (30)