Disc Degenerative Disease
Conditions
Brief summary
Research Hypothesis: There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.
Interventions
DRUGPlacebo
Placebo matching YH14618
DRUGYH14618
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed as one or two symptomatic early lumbar (L1/L2 \ L5/S1) degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI performed within 4 weeks prior to randomization. * Patients have suffered from persistent low back pain with at least 3-month conservative therapy. * Patients have low back pain measured by VAS≥4cm and mODI≥30% at screening and randomization visit (Day 0).
Exclusion criteria
* Clinically significant spine compression fracture, spinal stenosis, or spinal instability. * Clinically significant sacroiliac joint dysfunction, facet joint pain, or those who are suspected. * Modic change type III assessed by X-ray and MRI * History of spine surgery * Neurologic disorders. * Any other systemic disease which can influence spine such as rheumatoid arthritis, ankylosing spondylitis, or autoimmune disease. * Participation in other clinical trials with intradiscal injection (eg, Phase 1/2a YH14618-201 trial, or Cell therapy, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of VAS responders | at 12-week | Proportion of VAS responders defined as those who achieve ≥ 50% reduction in VAS at week 12 from baseline |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of VAS responders | at 24-week |
| Proportion of mODI responder | at 12-week, 24-week |
| Changes in VAS score from baseline | Each visit for 24 weeks |
| Changes in mODI score from baseline | Each visit for 24 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in mODI from Week 12 to Week 16, 20, and 24 | Each visit between Week 12 and 24 | — |
| Time to achieve the first ≥ 50% reduction in VAS following the intradiscal injection of Investigational product | For 24 weeks | — |
| Pfirrmann grade using MRI at Week 24 | Screening, Week 24 | — |
| Percent change from baseline to Week 24 for Disc Height Index (DHI) | Screening, Week 24 | — |
| Quality of life measured by EQ-5D and SF-12 | at Week 12 and 24 | — |
| Quality of life measured by EQ-5D | at Week 12 and 24 | — |
| Change in VAS from Week 12 to Week16, 20, and 24 | Each visit between Week 12 and 24 | — |
| Patient global impression of change | at Week 12 and 24 | — |
| Clinical global impression of change | at Week 12 and 24 | — |
| Time to analgesic rescue following the intradiscal injection of Investigational product | For 24 weeks | — |
| Amount of rescue medication tablets taken following the intradiscal injection of Investigational product | For 24 weeks | — |
| The number of days taken rescue medication following the intradiscal injection of investigational product | For 24 weeks | — |
| Quality of life measured by SF-12 | at Week 12 and 24 | — |
| Proportion of moderate VAS responder | at 12-week, 24-week | Moderate VAS responder are defined as those who achieve ≥ 30% reduction in VAS from baseline |
| Percent change from baseline to Week 12 and 24 for VAS | Each visit between Week 12 and 24 | — |
| Proportion of patients who are being VAS responders at Week 12 and maintain the treatment effect of ≥ 50% reduction in VAS up to week 16, 20, and 24 | Each visit between Week 12 and 24 | — |
| Proportion of patients who are being mODI responders at Week 12 and maintain the treatment effect of ≥ 15 points reduction in mODI up to week 16, 20, and 24 | Each visit between Week 12 and 24 | — |
Countries
South Korea
Outcome results
None listed