Lumbar Degenerative Disc DiseasePhase 3MODELNCT05516992
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
A Phase 3 study testing SB-01 For Injection in people with Lumbar Degenerative Disc Disease, run by Spine BioPharma, Inc at 30 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- What is being tested?
- SB-01 For Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- 30 sitesUnited States
- Study dates
- 19 Aug 2022to 27 Aug 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows.
- 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:
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- 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:
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
HD Research
Bellaire, Texas, 77401
Central Alabama Research
Birmingham, Alabama, 35209
Injury Care Research
Boise, Idaho, 83713
Meta Medical Research Institute
Cincinnati, Ohio, 45069
META Medical Research Institute
Dayton, Ohio, 45432
Science Connections, LLC
Doral, Florida, 33178
NeuroCare Partners
Houston, Texas, 77008
The Orthopaedic Research Foundation, Inc (OrthoIndy)
Indianapolis, Indiana, 46278
Coastal Clinical Research
Jacksonville, Florida, 32205
Neurovations Research
Napa, California, 94558
Pioneer Clinical Research
New York, New York, 10016
Vista Clinical Research, LLC
Newnan, Georgia, 30265
OrthoNebraska
Omaha, Nebraska, 68144
Conquest Research
Orlando, Florida, 32804
Conquest Research
Orlando, Florida, 32832
Evolve Clinical Research
Phoenix, Arizona, 85013
Virginia iSpine Physicians
Richmond, Virginia, 23235
Wasatch Clinical Research
Salt Lake City, Utah, 84107
University of Utah
Salt Lake City, Utah, 84108
South Texas Spinal Clinic
San Antonio, Texas, 78240
Source Healthcare
Santa Monica, California, 90403
Pain Relief Centers
St. Petersburg, Florida, 33709
Tampa Pain Relief Center
Tampa, Florida, 33603
Florida Pain Relief Group
Tampa, Florida, 33614
The Orthopedic Center
Tulsa, Oklahoma, 74104
Precision Spine Care
Tyler, Texas, 75701
Gershon Pain Specialists
Virginia Beach, Virginia, 23454
Tranquil Clinical Research
Webster, Texas, 77598
Abay Neuroscience Center
Wichita, Kansas, 67226
Conquest Research
Winter Park, Florida, 32789
About this study
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
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
- Being tested
- SB-01 For Injection, Sham Needle
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-01 For InjectionDrug
Intradiscal injection
Sham NeedleDrug
Sham needle placement
| Study group | Role | What they receive |
|---|---|---|
| SB-01 For Injection | Experimental | Subjects receive a SB-01 For Injection intradiscal injection per treated disc. Receives: Drug: SB-01 For Injection |
| Sham Needle | Placebo comparator | Subjects receive a sham needle placement for each treated disc. Receives: Drug: Sham Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Baseline/Screening and 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start19 Aug 2022
- Primary completion21 Mar 2025
- Study completion27 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine BioPharma, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Christopher Gilligan, MD, MBA, Principal investigator, Brigham and Women's Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516992
- Sponsor's protocol ID
- SB01-M001
- Acronym
- MODEL
- Status last verified
- Jun 2025
- First submitted
- 24 Aug 2022
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05516992
- Acronym / sponsor ID
- MODEL / SB01-M001
- Conditions
- Lumbar Degenerative Disc Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Spine BioPharma, IncIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 27 Aug 2025 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB-01 For Injection | Experimental | Drug: SB-01 For InjectionSubjects receive a SB-01 For Injection intradiscal injection per treated disc. |
| Sham Needle | Placebo comparator | Drug: Sham NeedleSubjects receive a sham needle placement for each treated disc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (40 listed)
- To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB-01 For InjectionIntradiscal injection | Drug | SB-01 For Injection |
| Sham NeedleSham needle placement | Drug | Sham Needle |
Primary outcome
Change from Baseline in function on the Oswestry Disability Index (ODI) at 6 months.
Time frame: Baseline/Screening and 6 Month
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.
1 secondary outcome
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.
Time frame: Baseline/Screening and 6 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Gilligan, MD, MBA principal investigator
Brigham and Women's Spine Center
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SB-01 For Injection in people with Lumbar Degenerative Disc Disease, run by Spine BioPharma, Inc at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in function on the Oswestry Disability Index (ODI) at 6 months. (time frame: Baseline/Screening and 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.