Primary Progressive Multiple SclerosisPhase 2NCT07840326
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
A Phase 2 study testing SUN-627 in people with Primary Progressive Multiple Sclerosis and Primary Progressive MS, run by Sundance Biosciences, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Progressive Multiple Sclerosis, Primary Progressive MS, Primary Progressive Multiple Sclerosis (PPMS)
- What is being tested?
- SUN-627
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2026to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Local Institution - Site 102
Atlanta, Georgia, 30309
- Recruiting
Local Institution - Site 104
Columbus, Ohio, 43235
- Recruiting
Local Institution - Site 101
Raleigh, North Carolina, 27607
About this study
Official 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)
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.
Read the 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.
- Conditions
- Primary Progressive Multiple Sclerosis, Primary Progressive MS, Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive MS (SPMS), Secondary Progressive Multiple Sclerosis (SPMS), Secondary Progressive MS
- Being tested
- SUN-627, Placebo
- Keywords
- Primary Progressive Multiple Sclerosis, Primary Progressive MS, Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS), Secondary Progressive MS (SPMS), Secondary Progressive Multiple Sclerosis, Secondary Progressive MS, Primary Progressive MS (PPMS), Non-Active SPMS, Non-Active Secondary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis with inflammatory disease activity, TYK2, CNS penetrant TYK2, Demyelinating disease, CNS demyelinating disease, Multiple Sclerosis, Confirmed disability progression, NfL, GFAP, Neuroinflammation
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Demyelinating Diseases, Multiple Sclerosis, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUN-627Drug
Also called NEU-627, N-004850
SUN-627, a once daily, orally administered, immediate release tablet
PlaceboOther
Orally-administered matched placebo
| Study group | Role | What they receive |
|---|---|---|
| SUN-627 Dose Level 1 | Experimental | SUN-627, taken orally QD Receives: Drug: SUN-627 |
| SUN-627 Dose Level 2 | Experimental | SUN-627, taken orally QD Receives: Drug: SUN-627 |
| SUN-627 Placebo | Placebo comparator | SUN-627 Placebo, taken orally QD Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
Measured: From enrollment to the end of study at 16 weeks
Secondary outcomes (2)
The maximum concentration (Cmax) of SUN-627 in plasma
Measured: From enrollment to end of treatment at 12 weeks
Change from baseline in neuroinflammation biomarkers
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sundance Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840326
- Sponsor's protocol ID
- SUN-627-MS202
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07840326
- Acronym / sponsor ID
- SUN-627-MS202
- Conditions
- Primary Progressive Multiple Sclerosis, Primary Progressive MS, Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive MS (SPMS), Secondary Progressive Multiple Sclerosis (SPMS), Secondary Progressive MS
- Keywords
- Primary Progressive Multiple Sclerosis, Primary Progressive MS, Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS), Secondary Progressive MS (SPMS), Secondary Progressive Multiple Sclerosis, Secondary Progressive MS, Primary Progressive MS (PPMS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sundance Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SUN-627 Dose Level 1 | Experimental | Drug: SUN-627SUN-627, taken orally QD |
| SUN-627 Dose Level 2 | Experimental | Drug: SUN-627SUN-627, taken orally QD |
| SUN-627 Placebo | Placebo comparator | Other: PlaceboSUN-627 Placebo, taken orally QD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUN-627Also: NEU-627, N-004850SUN-627, a once daily, orally administered, immediate release tablet | Drug | SUN-627 Dose Level 1, SUN-627 Dose Level 2 |
| PlaceboOrally-administered matched placebo | Other | SUN-627 Placebo |
Primary outcome
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
2 secondary outcomes
The maximum concentration (Cmax) of SUN-627 in plasma
Time frame: From enrollment to end of treatment at 12 weeks
Change from baseline in neuroinflammation biomarkers
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUN-627 in people with Primary Progressive Multiple Sclerosis and Primary Progressive MS, run by Sundance Biosciences, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chetan Gandhy, MD (650-442-3187, clinicaltrials@sundancebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.