Human Subjects Study of SUN-627 for Non-Active SPMS/PPMS
A Phase 2 clinical trial evaluated the safety and tolerability of SUN-627 in adults with non-active secondary and primary progressive multiple sclerosis (SPMS/PPMS). It was a randomized, double-blind, placebo-controlled study focusing on treatment-emergent adverse events and the drug's effects on neuroinflammation measures. However, no results have been posted yet.
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Why it matters
Understanding whether SUN-627 is safe and tolerable can influence future treatments for SPMS/PPMS, potentially improving patient care.
What this does not prove
Since no results are published, we cannot conclude on the effectiveness or safety of SUN-627. The study's planned enrollment and endpoints do not indicate findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (10)
study phaseThe 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.
study designThis 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.
subjects"detailedDescription": "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."
randomized"detailedDescription": "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."
controlled"detailedDescription": "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."
intervention"description": "SUN-627 Placebo, taken orally QD",
comparator"detailedDescription": "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."
primary endpoint"measure": "Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo",
findings"detailedDescription": "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."
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.