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NCT Number: NCT07840326

A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)

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.

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Key information

Conditions

Primary Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Inflammation Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Neuroinflammatory Diseases Non-Active SPMS Non-Active Secondary Progressive Multiple Sclerosis Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Progressive MS Primary Progressive Multiple Sclerosis (PPMS) Secondary Progressive MS Secondary Progressive MS (SPMS) Secondary Progressive Multiple Sclerosis (SPMS) Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - Site 102, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SUN-627

Drug

SUN-627, a once daily, orally administered, immediate release tablet

Other names: NEU-627, N-004850

Placebo

Other

Orally-administered matched placebo

Primary outcomes

  1. 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

  1. The maximum concentration (Cmax) of SUN-627 in plasma

    Time frame: From enrollment to end of treatment at 12 weeks

  2. Change from baseline in neuroinflammation biomarkers

    Time frame: From enrollment to the end of treatment at 12 weeks

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Sundance Biosciences, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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