Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05516992

Acronym

MODEL

Enrollment

417

Registered

2022-08-26

Start date

2022-08-19

Completion date

2025-08-27

Last updated

2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Degenerative Disc Disease

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.

Interventions

DRUGSB-01 For Injection

Intradiscal injection

DRUGSham Needle

Sham needle placement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Double-blind, placebo-controlled study.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in function on the Oswestry Disability Index (ODI) at 6 months.	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.

Secondary

Measure	Time frame	Description
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	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026