A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of SUN-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Impact on Measures of Neuroinflammation in the Central Nervous System in Participants With Non-Active Progressive Multiple Sclerosis (SPMS/PPMS)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The Sponsor is also masked.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SUN-627 Dose Level 1
SUN-627, taken orally QD
Intervention: SUN-627 (Drug)
SUN-627 Dose Level 2
SUN-627, taken orally QD
Intervention: SUN-627 (Drug)
SUN-627 Placebo
SUN-627 Placebo, taken orally QD
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
Time Frame: From enrollment to the end of study at 16 weeks
Secondary Outcomes
- The maximum concentration (Cmax) of SUN-627 in plasma(From enrollment to end of treatment at 12 weeks)
- Change from baseline in neuroinflammation biomarkers(From enrollment to the end of treatment at 12 weeks)