Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Trial to Evaluate the Efficacy and Safety of YH14618 in Patients With Lumbar Degenerative Disc Disease

Conditions
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Disc Degenerative Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: YH14618


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Placebo | Drug: Placebo<br>* Placebo matching YH14618<br>|
| Experimental: Group A<br>YH14618 A mg/disc | Drug: YH14618<br> <br> |
| Experimental: Group B<br>YH14618 B mg/disc | Drug: YH14618<br> <br> |
| Experimental: Group C<br>YH14618 C mg/disc | Drug: YH14618<br> <br> |
| Experimental: Group D<br>YH14618 D mg/disc | Drug: YH14618<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of VAS responders | Proportion of VAS responders defined as those who achieve ≥ 50% reduction in VAS at week 12 from baseline | at 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |