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

October 28, 2026 updated by: Sundance Biosciences, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SUN-627 Dose Level 1

SUN-627, taken orally QD
Drug: SUN-627

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

Other Names:
  • NEU-627
  • N-004850
Experimental: SUN-627 Dose Level 2

SUN-627, taken orally QD
Drug: SUN-627

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

Other Names:
  • NEU-627
  • N-004850
Placebo Comparator: SUN-627 Placebo

SUN-627 Placebo, taken orally QD
Other: Placebo

Orally-administered matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment to the end of study at 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The maximum concentration (Cmax) of SUN-627 in plasma
Time Frame: From enrollment to end of treatment at 12 weeks
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
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sundance Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 18, 2026

First Submitted That Met QC Criteria

September 18, 2026

First Posted (Actual)

September 25, 2026

Study Record Updates

Last Update Posted (Actual)

October 30, 2026

Last Update Submitted That Met QC Criteria

October 28, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUN-627-MS202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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