NCT07840326 · Sundance Biosciences, Inc.
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
What this study is about
The goal of this Phase 2 clinical trial is to investigate the safety and how well patients handle the treatment of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS/PPMS.
View original scientific description
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.
Interventions
DRUG
SUN-627
SUN-627, a once daily, orally administered, immediate release tablet
OTHER
Placebo
Orally-administered matched placebo
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Atlanta, Georgia
- Raleigh, North Carolina
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2026 · Source of record for eligibility and locations