SB-01 Injection for Degenerative Disc Disease

(MODEL Trial)

Not currently recruiting at 42 trial locations

Overseen By Malisa Agard, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Spine BioPharma, Inc

Disqualifiers: Chronic narcotic use, Depression, Extreme obesity, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injection treatment, SB-01, for individuals with chronic low back pain from Degenerative Disc Disease. The goal is to determine if this injection reduces pain and improves daily function more effectively than a placebo (a treatment with no active ingredient). Ideal participants have experienced chronic low back pain for at least six months and have not found relief with conservative treatments. As a Phase 3 trial, this study is the final step before FDA approval, giving participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you must stop taking your current medications, but it mentions that certain medications are prohibited. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SB-01 For Injection is safe. In earlier studies, patients who received a single injection of SB-01 into their spine tolerated it well, with no major safety issues reported. Even when some studies did not achieve all their goals, the safety of SB-01 remained consistent and reliable. Thus, based on past research, the treatment is considered safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care treatments for degenerative disc disease, which often involve pain medications, physical therapy, or surgery, SB-01 is unique because it is delivered directly into the affected disc via injection. This direct delivery method allows the treatment to target the source of the problem more effectively, potentially offering faster and longer-lasting relief. Researchers are excited about SB-01 because it represents a minimally invasive approach, which could reduce the need for more extensive surgical procedures and improve recovery times.

What evidence suggests that SB-01 For Injection might be an effective treatment for Degenerative Disc Disease?

Research shows that SB-01 For Injection, which participants in this trial may receive, may help treat chronic low back pain caused by Degenerative Disc Disease. In earlier studies, patients who received a single injection of SB-01 into their spine experienced lasting improvements. Although a recent study didn't achieve its main goal, SB-01 still outperformed a placebo in some locations. The treatment has demonstrated safety, consistent with earlier findings. Overall, these results suggest that SB-01 could help reduce pain and disability for patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Christopher Gilligan, MD

Principal Investigator

Brigham and Women's Spine Center

Are You a Good Fit for This Trial?

Adults over 18 with chronic low back pain from Lumbar Degenerative Disc Disease, confirmed by MRI. Participants must have tried conservative treatment for at least 3 months and be willing to use effective contraception if of childbearing potential. Exclusions include prior spine surgery, certain MRI findings like disc herniation or severe facet arthrosis, chronic narcotic use, systemic infections, active malignancy, pregnancy, and involvement in other clinical trials.

Inclusion Criteria

Not Applicable. It seems that the criterion was not completed.

My lower back discs are moderately to severely degenerated.

Willing and able to comply with this protocol and be available for the entire duration of the study, including ability to access the internet

Exclusion Criteria

MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab

My MRI shows nerve compression due to spinal narrowing.

I am currently fighting an infection in my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SB-01 For Injection or sham needle placement for lumbar degenerative disc disease

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SB-01 For Injection
• Sham Needle

Trial Overview The trial is testing the safety and effectiveness of SB-01 For Injection compared to a sham needle (placebo) in reducing pain-related disability due to lumbar degenerative disc disease. The goal is to see if patients receiving SB-01 experience more significant improvements than those receiving the placebo.

How Is the Trial Designed?

Group I: SB-01 For Injection Experimental Treatment 1 Intervention

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

Group II: Sham Needle Placebo Group 1 Intervention

Subjects receive a sham needle placement for each treated disc.

Who Is Running the Clinical Trial?

Spine BioPharma, Inc

Lead Sponsor

Trials

1

Recruited

420+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

MCRA, LLC

Industry Sponsor

Trials

19

Recruited

7,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05516992

NCT05516992 | Moderate - Severe Degenerative Disc ... 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

2. spinebiopharma.com spinebiopharma.com/spinebio-news/spine-biopharma-announces-topline-results-from-phase-3-model-trial-for-sb-01-vicatertide-in-chronic-low-back-pain-associated-with-degenerative-disc-disease

Spine BioPharma Announces Topline Results from Phase ... A single intradiscal injection of SB-01 in CLBP patients associated with DDD demonstrated: A robust safety profile consistent with the previous Phase 2 study.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/spine-biopharma-sb-01/

Spine BioPharma's trial of SB-01 fails to meet primary ... Spine BioPharma's Phase III MODEL trial assessing SB-01 for people with CLBP associated with DDD failed to achieve its primary goal.

4. pharmexec.com pharmexec.com/view/spine-biopharma-antagonist-misses-primary-endpoint-phase-iii-degenerative-disc-disease-trial

Spine BioPharma's TGF-β Antagonist Misses Primary ... Despite missing the primary endpoint, SB-01 demonstrated durable clinical improvements and consistent results in the Phase III MODEL trial ...

5. finance.yahoo.com finance.yahoo.com/news/spine-biopharma-announces-topline-results-130000667.html

Spine BioPharma Announces Topline Results from Phase ... In sites with an anticipated sham control response, SB-01 outperformed the sham control, almost achieving nominal statistical significance p= ...