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New pill shows promise for MS control in early trial

NCT ID NCT06083753

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study tested an experimental oral drug called PIPE-307 in 182 adults with relapsing-remitting multiple sclerosis (MS). Participants took either a low or high dose of PIPE-307 or a placebo daily for about 30 weeks, alongside their usual MS medication. The goal was to see if the drug is safe and can improve vision and physical function. The trial is now complete, and results will show whether PIPE-307 deserves further study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PIPE-307 (oral drug)
What this could lead to
If successful, PIPE-307 could offer a new add-on option to help control relapsing-remitting MS and potentially improve vision and mobility.
What could go wrong
This is an early Phase 2 trial with only 182 people, so results may not confirm benefit. The drug is tested as an add-on, not a standalone treatment, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

182 people

The number who actually took part.

Started

Nov 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Alta Bates Summit Medical Center

    Berkeley, California, 94705, United States

  • Aqualane Clinical Research

    Naples, Florida, 34105, United States

  • Arizona Neuroscience Research, LLC

    Phoenix, Arizona, 85032, United States

  • Bhupesh Dihenia, MD, PA

    Lubbock, Texas, 79410, United States

  • Clinical Trial Network

    Houston, Texas, 77074, United States

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907, United States

  • Dent Neurologic Institute

    Amherst, New York, 14226, United States

  • MS and Neuromuscular Center of Excellence

    Clearwater, Florida, 33761, United States

  • Multicare Neuroscience Center of Washington

    Tacoma, Washington, 98405, United States

  • Neurological Associates of Long Island, P.C.

    Lake Success, New York, 11042, United States

  • Neurology Center of New England P.C.

    Foxborough, Massachusetts, 02035, United States

  • Oklahoma Research Foundation - MS Center of Excellence

    Oklahoma City, Oklahoma, 73104, United States

  • Shepherd Center

    Atlanta, Georgia, 30309, United States

  • Sibyl Wray Neurology PC

    Knoxville, Tennessee, 37922, United States

  • UW Medicine MS Center

    Seattle, Washington, 98133, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

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

    Albuquerque, New Mexico, 87106, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Xenosciences

    Phoenix, Arizona, 85004, United States

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