Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

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.

Timeline

Start

2022-08-19

Primary completion

2025-03-21

Completion

2025-08-27

Outcome

Missed primary endpoint

release “이번 3상에서 SB-01은 안전성 및 효능을 확인했지만 일부 임상 기관의 위약군에서 높은 효능반응이 나타나면서 통계적 유의성을 확보하지는 못했다.” ensolbio.com ↗

release “마크 비스코글리오시 CEO는 "1차 평가변수를 달성하지 못해 실망스럽지만” ensolbio.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SB-01	Unknown	—	Other

Indications