A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis
Summary
This was a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration was approximately 100 weeks and included the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B) The study was terminated prior to completion (of Week 96) as primary endpoint was not met. Therefore final duration was less than 96 weeks.
Timeline
- Start
- 2022-12-19
- Primary completion
- 2024-11-21
- Completion
- 2024-11-21
Outcome
Missed primary endpoint
Stopped: “The study was terminated as it did not meet its primary and key secondary endpoints”
registry analysis (superiority test); Part A: Placebo vs Part A: SAR443820; p = 0.8042 NCT05630547 ↗
release “participants with multiple sclerosis was discontinued based on not meeting the primary and key secondary endpoints.” denalitherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ODITRASERTIB | Small molecule | — | Oral |