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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 30

Awards & highlights

VISTA Trial Summary

This trial is testing a potential new MS drug on patients with relapsing-remitting MS. Subjects will get 1 of 3 treatments and be monitored for 30 weeks.

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.Check my eligibility

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.See study design

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.

VISTA Trial 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.

VISTA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in binocular 2.5% low contrast letter acuity (LCLA)

Treatment-emergent adverse events (TEAE)

Secondary outcome measures

Change in magnetic resonance imaging (MRI) measures of myelination and MS disease activity

Change in monocular 2.5% LCLA

Change in serum neurofilament light chain (NfL)

+5 more

VISTA 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

Find a Location

Who is running the clinical trial?

Pipeline Therapeutics, Inc.Lead Sponsor

4 Previous Clinical Trials

160 Total Patients Enrolled

3 Trials studying Multiple Sclerosis

132 Patients Enrolled for Multiple Sclerosis

Contineum TherapeuticsLead Sponsor

4 Previous Clinical Trials

160 Total Patients Enrolled

3 Trials studying Multiple Sclerosis

132 Patients Enrolled for Multiple Sclerosis

Stephen Huhn, MDStudy DirectorContineum Therapeutics

8 Previous Clinical Trials

213 Total Patients Enrolled

2 Trials studying Multiple Sclerosis

126 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to participate in this research trial?

"To partake in this research, individuals should possess a diagnosis of multiple sclerosis and must fall within the age range from 18 to 50. Currently, 168 candidates are accepted for enrollment."

Answered by AI

What is the current enrollment size of this clinical research?

"Indeed, the medical trial is actively recruiting according to clinicaltrials.gov. The study was first posted on November 6th 2023 and subsequently updated on November 16th of that same year. There are 168 patients needed at a single research centre."

Answered by AI

Are any geriatric patients involved in this trial?

"The age requirement for this clinical trial is between 18 and 50 years old."

Answered by AI

Are any participants being recruited for enrollment in this trial at present?

"Affirmative. According to the information available on clinicaltrials.gov, this medical experiment is presently recruiting participants. This endeavour was first uploaded on November 6th 2023 and was refreshed most recently on the 16th of November in that same year. A total of 168 test subjects are sought after from a single centre."

Answered by AI

Has PIPE-307 Dose A been authorized by the FDA?

"Although no efficacy data exists, there is evidence of PIPE-307 Dose A's safety which merits a score of 2 on the scale. This implies that Phase 2 trials are in progress."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis

2023. "Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06083753.

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