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

ConditionsPrimary Progressive Multiple SclerosisPrimary Progressive MSPrimary Progressive Multiple Sclerosis (PPMS)Secondary Progressive MS (SPMS)Secondary Progressive Multiple Sclerosis (SPMS)Secondary Progressive MSNon-Active SPMSNon-Active Secondary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis With Inflammatory Disease Activity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSundance Biosciences, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SUN-627

    Drug

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

  • Placebo

    Other intervention

    Orally-administered matched placebo

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: SUN-627 Dose Level 1Experimental treatment 1 intervention
Group B: SUN-627 Dose Level 2Experimental treatment 1 intervention
Group C: SUN-627 PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sundance Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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