What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis, particularly those with mechanisms of action similar to PIPE-307, include glatiramer acetate, dimethyl fumarate, and fingolimod. Glatiramer acetate can cause local injection site reactions and, less commonly, systemic reactions like chest pain and palpitations. Dimethyl fumarate is associated with gastrointestinal issues, flushing, and a potential decrease in lymphocyte counts. Fingolimod's side effects include headache, elevated liver enzymes, bradyarrhythmia, macular edema, and an increased risk of infections due to its immunomodulating effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Sclerosis (MS) that modulate the immune system to reduce relapse rates and slow disease progression. Notable examples include glatiramer acetate, which mimics myelin basic protein to induce anti-inflammatory T cells, and interferon beta-1a, which reduces inflammation and immune response. Dimethyl fumarate (BG-12) has also been approved, showing significant reductions in relapse rates and new brain lesions. Alemtuzumab, another approved drug, depletes immune cells to reduce relapse rates but is reserved for highly active cases due to its safety profile. These treatments highlight the diverse mechanisms targeting immune modulation in MS management.

What other types of research exist?

Promising novel alternatives to PIPE-307 for MS treatment include ASP4058, which is a novel agonist for sphingosine 1-phosphate receptors 1 and 5, showing a favorable safety profile compared to fingolimod. Additionally, masitinib, a selective oral tyrosine kinase inhibitor, has shown benefits in slowing disease progression and reducing neuroinflammation. Dimethyl fumarate (BG-12) is another effective oral treatment that significantly reduces relapse rates and new brain lesions in patients with relapsing-remitting MS.

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Monoclonal Antibodies

PIPE-307 for Multiple Sclerosis (VISTA Trial)

Phase 2

Recruiting

Research Sponsored by Pipeline Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female 18 to 50 years of age, inclusive, at the first Screening visit.

A diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2017 Revised McDonald Criteria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 26 (end of treatment period)

Summary

This trial is testing a new drug called PIPE-307 to see if it can help people with relapsing-remitting multiple sclerosis. The drug likely works by calming the immune system to prevent nerve damage. The study will compare two different doses of PIPE-307 over several months.

Who is the study for?

This trial is for English-speaking adults aged 18 to 50 with relapsing-remitting multiple sclerosis, as per the Revised McDonald Criteria. Participants must have been on a stable dose of one MS drug for the past six months and agree to use effective contraception. They should be in good health aside from MS.

What is being tested?

The study tests PIPE-307 at two different doses against a placebo in people with relapsing-remitting multiple sclerosis. It's randomized and double-blind, meaning neither participants nor researchers know who gets which treatment, divided into three groups equally over about 30 weeks.

What are the potential side effects?

While specific side effects are not listed here, clinical trials like this monitor for any adverse reactions ranging from mild symptoms such as headaches or nausea to more serious ones related to organ function or immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 50 years old.

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I have been diagnosed with relapsing-remitting MS according to the latest criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 26 (end of treatment period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 26 (end of treatment period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 26 (end of treatment period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment-emergent adverse events (TEAE)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: PIPE-307 Dose BExperimental Treatment1 Intervention

Group II: PIPE-307 Dose AExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments primarily work by modulating the immune system to reduce inflammation and prevent further damage to the nervous system. For example, dimethyl fumarate (BG-12) activates the Nrf2 pathway, which reduces oxidative stress and inflammation, while glatiramer acetate mimics myelin basic protein, distracting the immune system from attacking myelin. These mechanisms are crucial for MS patients as they help to decrease the frequency of relapses, slow disease progression, and reduce the formation of new brain lesions, thereby improving overall quality of life.

Oral drugs in multiple sclerosis therapy: an overview and a critical appraisal.Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.