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Relapsing Remitting Multiple SclerosisPhase 2VISTANCT06083753

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

A Phase 2 study testing PIPE-307 Dose A and PIPE-307 Dose B in people with Relapsing Remitting Multiple Sclerosis, run by Janssen Research & Development, LLC at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Relapsing Remitting Multiple Sclerosis
What is being tested?
PIPE-307 Dose A and PIPE-307 Dose B
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
21 sitesUnited States
Study dates
6 Nov 2023to 4 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject is fluent in English.
  • 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.
  • Expanded Disability Status Scale (EDSS) and retinal nerve fiber layer within protocol requirements.
  • Stable immunomodulatory treatment on no more than a single DMT for RRMS over the 6 months prior to Screening, as determined by the PI.
  • Male or female subjects with reproductive potential agree to comply with a highly effective contraceptive method as per protocol through 1 month after last study drug administration as per protocol.
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  • General good medical health with no clinically significant or relevant abnormalities except those attributed to the underlying multiple sclerosis (MS), including medical history, physical exam, vital signs, ECG and laboratory evaluations, as assessed by the Investigator.
  • If enrolled in the visual evoked potential (VEP) sub-study, an additional inclusion criterion includes:
  • Screening VEP P100 latency greater than the upper limit of normal (as defined in the protocol) in at least one eye, OR a protocol-defined difference in VEP P100 latency between eyes.

Who cannot join

  • Diagnosis or history of symptoms of optic neuritis within 9 months prior to Screening in either eye.
  • Diagnosis of MS more than 10 years prior to Screening.
  • History of severe myopia, ophthalmologic or retinal disorder that would interfere with measurements of low contrast letter acuity (LCLA) or exam by optical coherence tomography (OCT), as determined by Investigator.
  • Concurrent use of dalfampridine or other 4-aminopyridine or diamino-4-aminopyridine drugs.
  • Clinical MS relapse or MS related treatment with corticosteroids within 6 months prior to or during Screening.
  • History of treatment with bone marrow transplantation, mitoxantrone, cyclophosphamide, atacicept, or irradiation.
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  • Use of any daily or routine anticholinergic medications within 30 days of Screening or concurrent during the study.
  • The presence of gadolinium enhancing lesions by MRI.
  • Use of any drugs known to strongly or moderately induce or inhibit Cytochrome P450 3A4 (CYP3A4) enzyme activity within 30 days prior to Screening or concurrent during the study.
  • Use of an investigational product, vaccine or intervention other than a non-interventional registry study within the greater of 30 days or 5 half-lives (if known) prior to Screening or expected during the study.
  • History of malignancy under current active treatment or considered at substantial risk for progression or recurrence during the study interval, and/or significant cardiac disorder or dysrhythmia, as determined by the Investigator.
  • History of a suicide attempt or suicidal behavior or considered at risk for suicide as judged by the PI using the Columbia-Suicide Severity Rating Scale (C-SSRS) as Screening.
  • If enrolled in the visual evoked potential (VEP) sub-study, an additional exclusion criterion includes:
  • History of an ophthalmologic or retinal disorder that would interfere with measurements of VEP, as determined by the Investigator.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • University of New Mexico/Health Science Center/MIND Imaging Center/MS Specialty Clinic

    Albuquerque, New Mexico, 87106

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Shepherd Center

    Atlanta, Georgia, 30309

  • Alta Bates Summit Medical Center

    Berkeley, California, 94705

  • MS and Neuromuscular Center of Excellence

    Clearwater, Florida, 33761

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • Neurology Center of New England P.C.

    Foxborough, Massachusetts, 02035

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Clinical Trial Network

    Houston, Texas, 77074

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Sibyl Wray Neurology PC

    Knoxville, Tennessee, 37922

  • Neurological Associates of Long Island, P.C.

    Lake Success, New York, 11042

  • Bhupesh Dihenia, MD, PA

    Lubbock, Texas, 79410

  • Aqualane Clinical Research

    Naples, Florida, 34105

  • Oklahoma Research Foundation - MS Center of Excellence

    Oklahoma City, Oklahoma, 73104

  • Xenosciences

    Phoenix, Arizona, 85004

  • Arizona Neuroscience Research, LLC

    Phoenix, Arizona, 85032

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • UW Medicine MS Center

    Seattle, Washington, 98133

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Multicare Neuroscience Center of Washington

    Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Oral PIPE-307 as an Adjunctive Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis

This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks.

Read the detailed description

This is a randomized, double-blind study of PIPE-307 or placebo given to 168 subjects randomized into one of 3 separate cohorts. They will be randomized 1:1:1 (PIPE-307 Dose A:Pipe 307 Dose B: Placebo). There will be a 28-day screening period followed by a 26-week treatment period. Safety will be assessed by periodic measurements of vital signs (VS), physical (PE) and neurological examinations, electrocardiograms (ECG), blood laboratory analyses and occurrence of adverse events (AE).

Being tested
PIPE-307 Dose A, PIPE-307 Dose B, Placebo
Keywords
Relapsing Remitting Multiple Sclerosis, PIPE 307, Multiple Sclerosis
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PIPE-307 Dose ADrug

    Subjects will receive daily oral doses of PIPE-307

  • PIPE-307 Dose BDrug

    Subjects will receive daily oral doses of PIPE-307

  • PlaceboDrug

    Subjects will receive daily oral matching dose of Placebo

Study groups in NCT06083753
Study groupRoleWhat they receive
PIPE-307 Dose AExperimentalNot described
Receives: Drug: PIPE-307 Dose A
PIPE-307 Dose BExperimentalNot described
Receives: Drug: PIPE-307 Dose B
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-emergent adverse events (TEAE)

    Number of participants with TEAEs

    Measured: From baseline to week 26 (end of treatment period)

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

    Measured: From baseline to week 26 (end-of-study)

Secondary outcomes (8)

  1. Percentage of subjects with >/=5-letter gain in binocular 2.5% LCLA

    Measured: From baseline to week 26

  2. Change in monocular 2.5% LCLA

    Measured: From baseline to week 26

  3. Number of subjects with at least a 15% change in disability with the Timed 25-Foot Walk Test (T25WT)

    Measured: From baseline to week 26

  4. Number of subjects with at least a 15% change in disability with the Nine-Hole Peg Test (9HPT)

    Measured: From baseline to week 26

  5. Number of subjects with at least a 15% change in disability with the Symbol Digital Modality Test (SDMT)

    Measured: From baseline to week 26

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

    Measured: From baseline to week 26

  7. Change in serum neurofilament light chain (NfL)

    Measured: From baseline to week 26

  8. Pharmacokinetics: Change in blood concentration levels of PIPE-307

    Measured: From baseline to week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2023
  2. Study start6 Nov 2023
  3. Primary completion14 Jul 2025
  4. Study completion4 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06083753
Sponsor's protocol ID
PIPE 307-201
Acronym
VISTA
Status last verified
Sep 2026
First submitted
9 Oct 2023
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PIPE-307 Dose A and PIPE-307 Dose B in people with Relapsing Remitting Multiple Sclerosis, run by Janssen Research & Development, LLC at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent adverse events (TEAE) (time frame: From baseline to week 26 (end of treatment period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06083753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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