SUN-627 in non-active SPMS/PPMS: a Phase 2a test in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2a study to evaluate SUN-627 at two dose levels in adults with non-active SPMS or PPMS. The study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on CNS neuroinflammation. Participants must be 18-70 years old, have PPMS or non-active SPMS, no relapses in 2 years, and documented progression. Exclusion criteria include certain cardiac conditions, active infections, and recent participation in another trial. The study is led by Sundance Biosciences and conducted at three sites in Tampa, Atlanta, and Stony Brook.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-70, inclusive
2. Diagnosis of PPMS or non-active SPMS
3. No MS relapses in the past 2 years
4. Evidence that MS has continued to get worse over time
5. A level of disability that fits the study requirements

Exclusion Criteria:

1. Use of certain medications or treatments before the study, or need for these treatments during the study
2. Current participation in another research study
3. Certain abnormal heart rhythm findings on ECG or other heart conditions that may increase risk
4. Certain serious or unstable medical conditions that could make the study unsafe
5. Active infection, recent infection, or a history of repeated infections

Additional inclusion and exclusion criteria are outlined in the full study protocol.

Where it's running

• Local Institution - Site 103
  Tampa, Florida, United States Recruiting
• Local Institution - Site 102
  Atlanta, Georgia, United States Recruiting
• Local Institution - Site 101
  Raleigh, North Carolina, United States Recruiting
• Local Institution - Site 104
  Columbus, Ohio, United States Recruiting
• Local Institution - Site 105
  Oklahoma City, Oklahoma, United States Recruiting
• Local Institution - Site 106
  Stony Brook, New York, United States Not yet recruiting

Study contacts

• Study coordinator: Chetan Gandhy, MD
• Email: clinicaltrials@sundancebio.com
• Phone: 650-442-3187

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.