CompletedPhase 2Relapsing MSNCT06083753

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 15 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • PIPE-307 Dose A
  • PIPE-307 Dose B

Placebo or sham

  • Placebo

What it measured

Main measures

  • Treatment-emergent adverse events (TEAE)

    From baseline to week 26 (end of treatment period)

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

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

    Vision

Other measures (8)

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

    From baseline to week 26

  • Change in monocular 2.5% LCLA

    From baseline to week 26

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

    From baseline to week 26

    Disability progressionWalking and mobility
  • Number of subjects with at least a 15% change in disability with the Nine-Hole Peg Test (9HPT)

    From baseline to week 26

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

    From baseline to week 26

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

    From baseline to week 26

    MRI lesions
  • Change in serum neurofilament light chain (NfL)

    From baseline to week 26

    Blood or spinal fluid markers
  • Pharmacokinetics: Change in blood concentration levels of PIPE-307

    From baseline to week 30

    How the body handles the medicine

Who could take part

Relapsing MS · 18 to 50

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Nov 2023

      2. Main results due

        Jul 2025

      3. Finished

        Aug 2025

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