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Safety and Tolerability of Oral SUN-627 in Adults with Non‑Active Progressive Multiple Sclerosis (SPMS/PPMS) – Phase 2a Study

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people with Multiple Sclerosis, specifically those who have the non‑active forms known as Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis. The medication being tested is an oral tablet called SUN-627, taken by mouth in a dose of 120 mg each day.

The main goal of the trial is to assess the safety and tolerability of the drug. Participants will take the study tablet for about three months and will have regular visits where blood samples are taken and brain imaging is performed to look at signs of inflammation in the brain, known as neuroinflammation. Simple explanations of technical terms are provided: pharmacokinetics refers to how the body absorbs, distributes, and removes the drug, while pharmacodynamics describes how the drug affects the body’s cells and systems.

Throughout the study, researchers will watch for any side effects, record any health problems that arise, and compare laboratory and imaging results from the start of the trial to the end of the treatment period to understand how the drug influences disease activity.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After you join the study, you will sign a consent form that explains the trial and your rights.
The study staff will confirm that you meet the eligibility criteria for non‑active progressive multiple sclerosis.
Step 2
Baseline assessments
You will undergo initial examinations that may include a physical exam, blood draw, and brain imaging to record your health status before treatment begins.
These assessments provide reference data for safety and inflammation measures.
Step 3
Start of medication
You will receive sun-627 tablets for oral use.
Each tablet contains 120 mg of the active substance.
The first dose is taken on the day after baseline assessments.
Step 4
Daily dosing period
You will take one sun-627 tablet by mouth each day.
The daily dosing continues for a total of twelve weeks.
Step 5
Scheduled safety visits
At week 4, week 8, and week 12 you will attend study visits where the staff will check for any side effects, take blood samples, and may repeat imaging studies.
These visits help monitor the safety and tolerability of the medication.
Step 6
End of treatment
At the end of week 12 you will stop taking sun-627.
A final set of assessments will be performed to evaluate any changes in disease markers.
Step 7
Post‑treatment follow‑up
Four weeks after stopping the medication (week 16) you will have a final safety visit.
The purpose of this visit is to confirm that no new adverse events have occurred since the end of treatment.

Who can join the trial?

6 criteria

Be between 18 and 70 years old, including the end points.
Have a doctor’s diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or non‑active Secondary Progressive Multiple Sclerosis (SPMS). Primary Progressive means the disease has been steadily getting worse from the start, and non‑active SPMS means the disease is progressing but without recent flare‑ups.
Not have had any MS relapses (sudden worsening of symptoms) in the last two years.
Show clear evidence that the disease has been gradually worsening over time, even without relapses.
Have a level of physical or neurological disability that matches what the study requires (the study will assess how the disease is affecting daily activities).
Agree that there may be other requirements detailed in the full study protocol.

Who cannot join the trial?

5 criteria

Taking certain medicines or receiving specific treatments before the study, or needing those medicines or treatments while the study is happening. Medications are drugs that treat health problems, and treatments can include procedures or therapies.
Being enrolled in another research study at the same time.
Having an abnormal heart rhythm shown on an ECG (a simple test that records the heart’s electrical activity) or having other heart problems that could raise the risk of participation.
Having serious or unstable health problems that could make taking part unsafe. Serious or unstable medical conditions are illnesses that are severe, worsening, or not well‑controlled.
Having an active infection, a recent infection, or a history of getting infections repeatedly. An infection means germs such as bacteria or viruses are causing illness in the body.

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Verified sites

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Turku University Hospital
Verified
Turku, Finland

Trial locations

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Investigated drugs

SUN-627 is an experimental oral tablet being tested in people with non‑active progressive multiple sclerosis. In this study the medicine is taken by mouth and researchers are looking at how safe it is, how well people can tolerate it, and how it moves through and works in the body. The trial also examines whether the drug can affect signs of inflammation in the brain and spinal cord, which are important factors in this type of multiple sclerosis.

What is already known about the treatment

SUN-627 - SUN-627 is taken as a 120 mg oral tablet, meaning it is swallowed whole and absorbed through the gut. It is an experimental drug currently being studied in early‑stage clinical trials, so it is not yet approved for routine medical use. The tablet is being tested for people with non‑active progressive forms of multiple sclerosis, where it may help reduce inflammation in the brain and spinal cord. It works by gently blocking a specific protein that triggers immune cells to attack nerve tissue, placing it in the class of oral immunomodulators.

Investigated diseases

Multiple Sclerosis
A chronic condition in which the body’s immune system mistakenly attacks the protective covering of nerve fibers, causing communication problems between the brain and the rest of the body. Symptoms can appear in many different ways, such as weakness, numbness, or vision changes. The disease often shows periods of new symptoms or worsening, followed by times of relative stability. Over time, the accumulated damage can lead to increasing difficulty with movement and coordination.
Primary Progressive Multiple Sclerosis
A form of multiple sclerosis that starts with a steady increase in disability from the very beginning, without distinct relapses. The progression is usually gradual, with symptoms slowly worsening over months or years. Patients may notice a continuous decline in walking ability, balance, or strength.
Non-active Secondary Progressive Multiple Sclerosis
This stage follows an earlier pattern of relapses and remissions and then shifts to a steady worsening of symptoms, but currently shows little or no active inflammation. Disability continues to increase slowly, even though new flare‑ups are absent. The disease course is characterized by a gradual loss of function over time.