COMPLETED

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

Conditions

Relapsing Remitting Multiple Sclerosis PIPE 307 Multiple Sclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Oral PIPE-307 as an Adjunctive Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis

Quick Facts

Study Start:2023-11-06

Study Completion:2025-08-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06083753

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Stephen Huhn, MD

STUDY_DIRECTOR

Contineum Therapeutics

Study Locations (Sites)

Xenosciences

Phoenix, Arizona, 85004

United States

Arizona Neuroscience Research, LLC

Phoenix, Arizona, 85032

United States

Alta Bates Summit Medical Center

Berkeley, California, 94705

United States

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907

United States

MS and Neuromuscular Center of Excellence

Clearwater, Florida, 33761

United States

Aqualane Clinical Research

Naples, Florida, 34105

United States

Shepherd Center

Atlanta, Georgia, 30309

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Neurology Center of New England P.C.

Foxborough, Massachusetts, 02035

United States

Washington University School of Medicine

St Louis, Missouri, 63110

United States

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

Albuquerque, New Mexico, 87106

United States

Dent Neurologic Institute

Amherst, New York, 14226

United States

Neurological Associates of Long Island, P.C.

Lake Success, New York, 11042

United States

Oklahoma Research Foundation - MS Center of Excellence

Oklahoma City, Oklahoma, 73104

United States

Sibyl Wray Neurology PC

Knoxville, Tennessee, 37922

United States

University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Clinical Trial Network

Houston, Texas, 77074

United States

Bhupesh Dihenia, MD, PA

Lubbock, Texas, 79410

United States

Virginia Mason Medical Center

Seattle, Washington, 98101

United States

UW Medicine MS Center

Seattle, Washington, 98133

United States

Multicare Neuroscience Center of Washington

Tacoma, Washington, 98405

United States

Collaborators and Investigators

Sponsor: Contineum Therapeutics

Stephen Huhn, MD, STUDY_DIRECTOR, Contineum Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-06

Study Completion Date2025-08-04

Study Record Updates

Study Start Date2023-11-06

Study Completion Date2025-08-04

Terms related to this study

Keywords Provided by Researchers

Relapsing Remitting Multiple Sclerosis
PIPE 307
Multiple Sclerosis

Additional Relevant MeSH Terms

Relapsing Remitting Multiple Sclerosis