drugset / Trial / NCT03607838
SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)
Timeline
- Start
- 2018-11-07
- Primary completion
- 2022-08-03
- Completion
- 2023-03-21
Outcome
Met primary endpoint
paper For the primary endpoint, the condoliase group showed significantly greater improvement in CFB in worst leg pain at Week 13 PMID 39168360 ↗
registry analysis (superiority test); SI-6603 vs Sham; p = 0.0263; Mean Difference (Final Values) -7.5 (95% CI -14.1 to -0.9); Mixed Models Analysis NCT03607838 ↗
paper CONCLUSIONS: Condoliase met its primary endpoint of significantly improving radicular leg pain at Week 13 and was generally well tolerated in patients with LDH. PMID 39168360 ↗
Publications
- Macadaeg KE, Kim KD, Gupta PB, Rivera J, Patel A, Chauhan K, Watanabe J, Seo T, Zucker E, Candido K. Impact of Condoliase on Health-related Quality of Life in Participants With Radicular Leg Pain Associated With Lumbar Disk Herniation: Results From a United States Phase 3 Clinical Trial. Spine (Phila Pa 1976). 2025 Jun 15;50(12):796-803. doi: 10.1097/BRS.0000000000005327. Epub 2025 Mar 11.
- Kim KD, Ahadian F, Hassanzadeh H, Rivera J, Candido K, Gershon S, Patel A, Gupta PB, Miller AE, Formoso FJ, Fuerst T, Zucker E, Seo T, Watanabe J, Matsuyama Y, Chiba K, Macadaeg KE. A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 (condoliase) in patients with radicular leg pain associated with lumbar disc herniation. Spine J. 2024 Dec;24(12):2285-2296. doi: 10.1016/j.spinee.2024.08.006. Epub 2024 Aug 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Condoliase | Protein / enzyme biologic | 1.25 iu | Other |