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

NCT ID: NCT06083753

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2025-08-04

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.

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).

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PIPE-307 Dose A

Group Type: EXPERIMENTAL

PIPE-307 Dose A

Intervention Type: DRUG

Subjects will receive daily oral doses of PIPE-307

PIPE-307 Dose B

Group Type: EXPERIMENTAL

PIPE-307 Dose B

Intervention Type: DRUG

Subjects will receive daily oral doses of PIPE-307

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will receive daily oral matching dose of Placebo

Interventions

PIPE-307 Dose A

Subjects will receive daily oral doses of PIPE-307

Intervention Type: DRUG

PIPE-307 Dose B

Subjects will receive daily oral doses of PIPE-307

Intervention Type: DRUG

Placebo

Subjects will receive daily oral matching dose of Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Contineum Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Huhn, MD

Role: STUDY_DIRECTOR

Contineum Therapeutics

Locations

Xenosciences

Phoenix, Arizona, United States

Arizona Neuroscience Research, LLC

Phoenix, Arizona, United States

Alta Bates Summit Medical Center

Berkeley, California, United States

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

MS and Neuromuscular Center of Excellence

Clearwater, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Shepherd Center

Atlanta, Georgia, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Neurology Center of New England P.C.

Foxborough, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

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

Albuquerque, New Mexico, United States

Dent Neurologic Institute

Amherst, New York, United States

Neurological Associates of Long Island, P.C.

Lake Success, New York, United States

Oklahoma Research Foundation - MS Center of Excellence

Oklahoma City, Oklahoma, United States

Sibyl Wray Neurology PC

Knoxville, Tennessee, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Clinical Trial Network

Houston, Texas, United States

Bhupesh Dihenia, MD, PA

Lubbock, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

UW Medicine MS Center

Seattle, Washington, United States

Multicare Neuroscience Center of Washington

Tacoma, Washington, United States

Countries

United States

Other Identifiers

PIPE 307-201

Identifier Type: -

Identifier Source: org_study_id