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RecruitingNCT07840326Updated Oct 30, 2026

A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)

A Phase 2 interventional study of SUN-627 and Placebo in Primary Progressive Multiple Sclerosis, Primary Progressive MS and Primary Progressive Multiple Sclerosis (PPMS), sponsored by Sundance Biosciences, Inc.. Recruiting at 7 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Sundance Biosciences, Inc. · Phase 2, Interventional, and Treatment

Updated Oct 30, 2026Newly registered4 sites addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Primary Progressive Multiple Sclerosis
  • Primary Progressive MS
  • Primary Progressive Multiple Sclerosis (PPMS)
  • Secondary Progressive MS (SPMS)
  • Secondary Progressive Multiple Sclerosis (SPMS)
  • Secondary Progressive MS
  • Non-Active SPMS
  • Non-Active Secondary Progressive Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity

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
03

In context

Multiple Sclerosis, Chronic Progressive

244 studies on the registry are indexed under Multiple Sclerosis, Chronic Progressive; 53 are open to participants now.

This study's planned enrollment of 20 is below the median of 54 across 189 interventional studies indexed under Multiple Sclerosis, Chronic Progressive.

Browse Multiple Sclerosis, Chronic Progressive studies →

Lead sponsor

This is the only study on the registry with Sundance Biosciences, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    SUN-627 Dose Level 1

    SUN-627, taken orally QD

    Drug: SUN-627

  • Experimental
    SUN-627 Dose Level 2

    SUN-627, taken orally QD

    Drug: SUN-627

  • Placebo comparator
    SUN-627 Placebo

    SUN-627 Placebo, taken orally QD

    Other: Placebo

Interventions

  • DrugSUN-627

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

    Also known as: NEU-627, N-004850

  • OtherPlacebo

    Orally-administered matched placebo

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: From enrollment to end of treatment at 12 weeks

  2. Change from baseline in neuroinflammation biomarkers

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

5 of 7 sites recruiting
  • Local Institution - Site 103
    Tampa, Florida 33612, United States
    Recruiting
  • Local Institution - Site 102
    Atlanta, Georgia 30309, United States
    Recruiting
  • Local Institution - Site 106
    Stony Brook, New York 11794, United States
    Not yet recruiting
  • Local Institution - Site 101
    Raleigh, North Carolina 27607, United States
    Recruiting
  • Local Institution - Site 104
    Columbus, Ohio 43235, United States
    Recruiting
  • Local Institution - Site 105
    Oklahoma City, Oklahoma 73104, United States
    Recruiting
  • Local Institution - Site 107
    Dallas, Texas 75390, United States
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.

Of 25 phase 2 interventional studies under Multiple Sclerosis, Chronic Progressive, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2026
First posted
Sep 25, 2026
StartEst.
Oct 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jul 2027
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
4 sites added
Show 4 added (4 United States)
  • Local Institution - Site 103 · Tampa, United States
  • Local Institution - Site 106 · Stony Brook, United States
  • Local Institution - Site 105 · Oklahoma City, United States
  • Local Institution - Site 107 · Dallas, United States
Oct 30, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 2 updates
  1. Oct 30, 2026
    4 sites added
    Show 4 added (4 United States)
    • Local Institution - Site 103 · Tampa, United States
    • Local Institution - Site 106 · Stony Brook, United States
    • Local Institution - Site 105 · Oklahoma City, United States
    • Local Institution - Site 107 · Dallas, United States
    + 1 other change: verification date
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07840326
Lead sponsor
Sundance Biosciences, Inc.
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Chetan Gandhy, MD
Contact
clinicaltrials@sundancebio.com
650-442-3187

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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