NCT07840326PHASE2Recruiting
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Sundance Biosciences, Inc.
Start Date
10/1/2026
Completion Date
7/1/2027
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.
Eligibility Criteria
Age Range: 18 years to 70 years
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.
Interventions
DRUG
SUN-627
OTHER
Placebo
Conditions
Primary Progressive Multiple SclerosisPrimary Progressive MSPrimary Progressive Multiple Sclerosis (PPMS)Secondary Progressive MS (SPMS)Secondary Progressive Multiple Sclerosis (SPMS)Secondary Progressive MSNon-Active SPMSNon-Active Secondary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis With Inflammatory Disease Activity
Locations
Local Institution - Site 102
Atlanta, Georgia 30309
United States
Local Institution - Site 101
Raleigh, North Carolina 27607
United States
Local Institution - Site 104
Columbus, Ohio 43235
United States