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

Sundance Biosciences, Inc.

Status and phase: Enrolling; Phase 2

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

Treatments: Other: Placebo; Drug: SUN-627

Study type: Interventional

Funder types: Industry

Identifiers

NCT07840326

SUN-627-MS202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 3 patient groups, including a placebo group

SUN-627 Dose Level 1

Experimental group

Description:

SUN-627, taken orally QD

Treatment:

Drug: SUN-627

SUN-627 Dose Level 2

Experimental group

Description:

SUN-627, taken orally QD

Treatment:

Drug: SUN-627

SUN-627 Placebo

Placebo Comparator group

Description:

SUN-627 Placebo, taken orally QD

Treatment:

Other: Placebo