NCT07840326

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
9mo left

Started Oct 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jul 2027

First Submitted

Initial submission to the registry

September 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

Primary Progressive Multiple SclerosisPrimary Progressive MSSecondary Progressive MS (SPMS)Secondary Progressive Multiple Sclerosis (SPMS)Secondary Progressive MSNon-Active SPMSNon-Active Secondary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis With Inflammatory Disease ActivityPrimary Progressive Multiple Sclerosis (PPMS)

Keywords

Primary Progressive Multiple SclerosisPrimary Progressive MSPrimary Progressive Multiple Sclerosis (PPMS)Secondary Progressive Multiple Sclerosis (SPMS)Secondary Progressive MS (SPMS)Secondary Progressive Multiple SclerosisSecondary Progressive MSPrimary Progressive MS (PPMS)Non-Active SPMSNon-Active Secondary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis with inflammatory disease activityTYK2CNS penetrant TYK2Demyelinating diseaseCNS demyelinating diseaseMultiple SclerosisConfirmed disability progressionNfLGFAPNeuroinflammationchronic active lesionsSlowly expanding lesionsParamagnetic rim lesionsProgressive Multiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo

    From enrollment to the end of study at 16 weeks

Secondary Outcomes (2)

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

    From enrollment to end of treatment at 12 weeks

  • Change from baseline in neuroinflammation biomarkers

    From enrollment to the end of treatment at 12 weeks

Study Arms (3)

SUN-627 Dose Level 1

EXPERIMENTAL

SUN-627, taken orally QD

Drug: SUN-627

SUN-627 Dose Level 2

EXPERIMENTAL

SUN-627, taken orally QD

Drug: SUN-627

SUN-627 Placebo

PLACEBO COMPARATOR

SUN-627 Placebo, taken orally QD

Other: Placebo

Interventions

SUN-627DRUG

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

Also known as: NEU-627, N-004850
SUN-627 Dose Level 1SUN-627 Dose Level 2
PlaceboOTHER

Orally-administered matched placebo

SUN-627 Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution - Site 102

Atlanta, Georgia, 30309, United States

RECRUITING

Local Institution - Site 101

Raleigh, North Carolina, 27607, United States

RECRUITING

Local Institution - Site 104

Columbus, Ohio, 43235, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Chronic ProgressiveDemyelinating DiseasesMultiple SclerosisNeuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInflammation

Central Study Contacts

Chetan Gandhy, MD

CONTACT

650-442-3187clinicaltrials@sundancebio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The Sponsor is also masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 25, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)