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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Sundance Biosciences, Inc.
Study ID
NCT07840326
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SUN-627 — DRUG
    SUN-627, a once daily, orally administered, immediate release tablet
  • Placebo — OTHER
    Orally-administered matched placebo

Study Details

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.

Key Dates

First listed
Sep 25, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

Locations (3)

FacilityCityStateZIPSite coordinators
Local Institution - Site 102AtlantaGeorgia30309-
Local Institution - Site 101RaleighNorth Carolina27607-
Local Institution - Site 104ColumbusOhio43235-

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