20 Participants NeededMy employer runs this trial

SUN-627 for Multiple Sclerosis

Recruiting at 6 trial locations
CG
Overseen ByChetan Gandhy, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sundance Biosciences, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SUN-627 to determine its safety and tolerability for individuals with certain types of multiple sclerosis (MS). It targets those with primary progressive MS (PPMS) or non-active secondary progressive MS (SPMS) without recent relapses. Participants will receive either one of two doses of the treatment or a placebo, which contains no active drug. Ideal candidates are those whose MS has worsened over time but have not experienced a relapse in the past two years. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that SUN-627 is likely to be safe for humans?

Research has shown that SUN-627 has promising safety results from earlier studies. Healthy participants tolerated it well during testing. These studies found no major side effects in those taking SUN-627. This suggests the treatment might be safe for individuals, but ongoing research will provide more information about its safety for people with multiple sclerosis.12345

Why do researchers think this study treatment might be promising for multiple sclerosis?

Unlike the standard treatments for multiple sclerosis, which often include injectable therapies or infusion-based drugs, SUN-627 is taken orally, making it potentially more convenient for patients. Most existing treatments aim to modulate or suppress the immune system, but SUN-627 works differently by targeting specific pathways involved in the disease process. Researchers are excited about SUN-627 because it could offer a new mechanism of action that might reduce symptoms more effectively and with fewer side effects compared to current options. Additionally, the availability of multiple dosage levels in the trial provides an opportunity to optimize efficacy and minimize adverse effects, tailoring the treatment to individual patient needs.

What evidence suggests that SUN-627 might be an effective treatment for multiple sclerosis?

Research has shown that SUN-627 might help treat multiple sclerosis by targeting key aspects of the disease. This trial will evaluate different dose levels of SUN-627, which aims to reduce inflammation and protect nerve cells, often damaged in multiple sclerosis. Early studies of similar treatments have shown promising results, suggesting that SUN-627 could help reduce symptoms like fatigue and improve mobility. Although specific data on SUN-627's effectiveness is limited, its approach resembles other successful multiple sclerosis treatments. This similarity suggests that SUN-627 might offer real improvements for people with the condition.678910

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-70 who have been diagnosed with non-active secondary progressive or primary progressive multiple sclerosis (SPMS/PPMS).

Inclusion Criteria

A level of disability that fits the study requirements
My multiple sclerosis has gotten worse over time.
I have primary progressive or non-active secondary progressive MS.
See 2 more

Exclusion Criteria

Current participation in another research study
Certain serious or unstable medical conditions that could make the study unsafe
I have used or need to use specific medications or treatments during the study.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SUN-627 or placebo orally once daily to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and impact on neuroinflammation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SUN-627

Trial Overview

The study is testing a new drug called SUN-627 compared to a placebo. Participants are randomly assigned to receive either the drug or an inactive substance, and researchers will monitor safety and how well people tolerate it.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: SUN-627 Dose Level 2Experimental Treatment1 Intervention
Group II: SUN-627 Dose Level 1Experimental Treatment1 Intervention
Group III: SUN-627 PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sundance Biosciences, Inc.

Lead Sponsor

Citations

Biogen boosts multiple sclerosis research

Biogen boosts multiple sclerosis research. Evidence supports serum neurofilament light as useful biomarker; Biogen and Siemens to develop blood ...

New treatment perspectives in multiple sclerosis | MS Report

The article focused on clinical trials assessing the efficacy and safety of new preparations, such as Bruton?s tyrosine kinase inhibitors, masitinib, or ...

Multiple Sclerosis Therapeutics Market Size and Trends, ...

The multiple sclerosis therapeutics market is estimated to be valued at USD 32.77 Bn in 2026 and is expected to reach USD 44.30 Bn by 2033, ...

The current landscape and unmet needs in multiple sclerosis

The demand for more effective agents has produced a new generation of MS therapies with impressive efficacy profiles--although their long-term safety and ...

SUN-627 Shows Positive Phase 1 Results in Multiple ...

... multiple sclerosis (MS). --> Positive Phase 1 results: SUN-627 demonstrated favorable safety and tolerability in healthy volunteers, full ...

Sundance Biosciences Announces Presentation of Phase ...

SUN-627 demonstrated favorable safety, tolerability, and pharmacokinetics for oral, once-daily dosing in healthy volunteers.

Sundance Biosciences: Home

Sundance Biosciences is developing three oral therapies targeting TYK2, an enzyme that plays an important role in regulating the immune system.