New pill shows promise for MS control in early trial
NCT ID NCT06083753
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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182 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Aug 2025
- Lead sponsor
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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
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Alta Bates Summit Medical Center
Berkeley, California, 94705, United States
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Aqualane Clinical Research
Naples, Florida, 34105, United States
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Arizona Neuroscience Research, LLC
Phoenix, Arizona, 85032, United States
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Bhupesh Dihenia, MD, PA
Lubbock, Texas, 79410, United States
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Clinical Trial Network
Houston, Texas, 77074, United States
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Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
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Dent Neurologic Institute
Amherst, New York, 14226, United States
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MS and Neuromuscular Center of Excellence
Clearwater, Florida, 33761, United States
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Multicare Neuroscience Center of Washington
Tacoma, Washington, 98405, United States
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Neurological Associates of Long Island, P.C.
Lake Success, New York, 11042, United States
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Neurology Center of New England P.C.
Foxborough, Massachusetts, 02035, United States
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Oklahoma Research Foundation - MS Center of Excellence
Oklahoma City, Oklahoma, 73104, United States
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Shepherd Center
Atlanta, Georgia, 30309, United States
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Sibyl Wray Neurology PC
Knoxville, Tennessee, 37922, United States
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UW Medicine MS Center
Seattle, Washington, 98133, United States
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University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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University of New Mexico/Health Science Center/MIND Imaging Center/MS Specialty Clinic
Albuquerque, New Mexico, 87106, United States
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University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
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Virginia Mason Medical Center
Seattle, Washington, 98101, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Xenosciences
Phoenix, Arizona, 85004, United States
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