MedTrace Logo

Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

NCT05516992 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 417

Last updated 2025-06-10

No results posted yet for this study

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

Interventions

DRUG

SB-01 For Injection

Intradiscal injection

DRUG

Sham Needle

Sham needle placement

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Spine BioPharma, Inc

    lead INDUSTRY

Principal Investigators

  • Christopher Gilligan, MD, MBA · Brigham and Women's Spine Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-19
Primary Completion
2025-03-21
Completion
2025-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516992 on ClinicalTrials.gov