Overview
The goal of this Phase 2 clinical trial is to investigate the safety and tolerability of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS/PPMS.
Description
This Phase 2a, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and impact on measures of neuroinflammation in the central nervous system (CNS) of SUN-627 administered at 2 dose levels in participants with non-active SPMS/PPMS.
Eligibility
Inclusion Criteria:
- Aged 18-70, inclusive
- Diagnosis of PPMS or non-active SPMS
- No MS relapses in the past 2 years
- Evidence that MS has continued to get worse over time
- A level of disability that fits the study requirements
Exclusion Criteria:
- Use of certain medications or treatments before the study, or need for these treatments during the study
- Current participation in another research study
- Certain abnormal heart rhythm findings on ECG or other heart conditions that may increase risk
- Certain serious or unstable medical conditions that could make the study unsafe
- Active infection, recent infection, or a history of repeated infections
Additional inclusion and exclusion criteria are outlined in the full study protocol.
