Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

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.

Timeline

Start

2015-03

Primary completion

2016-04

Completion

2016-08

Outcome

Missed primary endpoint

release “유한양행이 임상 2b상에서 통계적 유의성을 확인하지 못해 개발을 중단했던 신약 후보물질을 기술수출하는 반전드라마를 썼다. 2016년 개발 중단했던 세계 최초 퇴행성디스크질환 치료제 신약후보물질 ‘YH14618’ 프로젝트다.” ensolbio.com ↗

Drugs

Indications