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

NCT06083753 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: PIPE 307-201
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Relapsing Remitting Multiple Sclerosis; PIPE 307; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Treatment-emergent adverse events (TEAE)

  Number of participants with TEAEs

  From baseline to week 26 (end of treatment period)

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

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

Secondary Outcomes (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

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

  From baseline to week 26

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

  From baseline to week 26

Study Arms (3)

PIPE-307 Dose A

EXPERIMENTAL

Drug: PIPE-307 Dose A

PIPE-307 Dose B

EXPERIMENTAL

Drug: PIPE-307 Dose B

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PIPE-307 Dose A DRUG

Subjects will receive daily oral doses of PIPE-307

PIPE-307 Dose A

PIPE-307 Dose B DRUG

Subjects will receive daily oral doses of PIPE-307

PIPE-307 Dose B

Placebo DRUG

Subjects will receive daily oral matching dose of Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• \- 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.

You may not qualify if:

• 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.
• \- History of an ophthalmologic or retinal disorder that would interfere with measurements of VEP, as determined by the Investigator.

Sponsors & Collaborators

• Contineum Therapeutics: lead

Study Sites (21)

Xenosciences

Phoenix, Arizona, 85004, United States

Location

Arizona Neuroscience Research, LLC

Phoenix, Arizona, 85032, United States

Location

Alta Bates Summit Medical Center

Berkeley, California, 94705, United States

Location

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

Location

MS and Neuromuscular Center of Excellence

Clearwater, Florida, 33761, United States

Location

Aqualane Clinical Research

Naples, Florida, 34105, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Neurology Center of New England P.C.

Foxborough, Massachusetts, 02035, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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

Albuquerque, New Mexico, 87106, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Neurological Associates of Long Island, P.C.

Lake Success, New York, 11042, United States

Location

Oklahoma Research Foundation - MS Center of Excellence

Oklahoma City, Oklahoma, 73104, United States

Location

Sibyl Wray Neurology PC

Knoxville, Tennessee, 37922, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Bhupesh Dihenia, MD, PA

Lubbock, Texas, 79410, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

UW Medicine MS Center

Seattle, Washington, 98133, United States

Location

Multicare Neuroscience Center of Washington

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stephen Huhn, MD

  Contineum Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: November 6, 2023
• Primary Completion: July 14, 2025
• Study Completion: August 4, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)