Recruiting
Phase 2

SUN-627

Sponsor:

Sundance Biosciences, Inc.

Code:

NCT07840326

Conditions

Primary Progressive Multiple Sclerosis

Primary Progressive MS

Primary Progressive Multiple Sclerosis (PPMS)

Secondary Progressive MS (SPMS)

Secondary Progressive Multiple Sclerosis (SPMS)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

SUN-627

Placebo

Study Details

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.

Conditions

Primary Progressive Multiple Sclerosis

Primary Progressive MS

Primary Progressive Multiple Sclerosis (PPMS)

Secondary Progressive MS (SPMS)

Secondary Progressive Multiple Sclerosis (SPMS)

Study ID

NCT07840326

Start date

Oct, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SUN-627 Dose Level 1

SUN-627, taken orally QD

experimental: SUN-627 Dose Level 2

SUN-627, taken orally QD

placebo comparator: SUN-627 Placebo

SUN-627 Placebo, taken orally QD

Interventions

SUN-627

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

Placebo

Orally-administered matched placebo

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 ]

Central Contacts and Locations

Central contacts

Chetan Gandhy, MD

650-442-3187clinicaltrials@sundancebio.com

Locations

Local Institution - Site 102

Recruiting

Atlanta, Georgia, United States, 30309

Local Institution - Site 101

Recruiting

Raleigh, North Carolina, United States, 27607

Local Institution - Site 104

Recruiting

Columbus, Ohio, United States, 43235

More Information

Sponsor

Sundance Biosciences, Inc.

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

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
  • chronic active lesions
  • Slowly expanding lesions
  • Paramagnetic rim lesions
  • Progressive Multiple sclerosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Sundance Biosciences, Inc. on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.