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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06083753
Other study ID # PIPE 307-201
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 6, 2023
Est. completion date September 2025

Study information

Verified date April 2024
Source Contineum Therapeutics
Contact Jules Lee
Email jlee@contineum-tx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 168
Est. completion date September 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PIPE-307 Dose A
Subjects will receive daily oral doses of PIPE-307
PIPE-307 Dose B
Subjects will receive daily oral doses of PIPE-307
Placebo
Subjects will receive daily oral matching dose of Placebo

Locations

Country Name City State
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 Shepherd Center Atlanta Georgia
United States Sutter East Bay Medical Foundation Berkeley California
United States MS and Neuromuscular Center of Excellence Clearwater Florida
United States Colorado Springs Neurological Associates Colorado Springs Colorado
United States Michigan Institute for Neurological Disorders (MIND) Farmington Hills Michigan
United States Neurology Center of New England P.C. Foxboro Massachusetts
United States Clinical Trial Network Houston Texas
United States Indiana University Health Neuroscience Center, Adult Neurology Center Indianapolis Indiana
United States University of Kansas Medical Center Kansas City Kansas
United States Sibyl Wray Neurology PC Knoxville Tennessee
United States Bhupesh Dihenia, MD, PA Lubbock Texas
United States Aqualane Clinical Research Naples Florida
United States Oklahoma Research Foundation - MS Center of Excellence Oklahoma City Oklahoma
United States Arizona Neuroscience Research, LLC Phoenix Arizona
United States Xenosciences Phoenix Arizona
United States Accel Research Sites Network - Brain & Spine Institute Port Orange Florida
United States Velocity Clinical Research, Raleigh Neurology Raleigh North Carolina
United States Washington University School of Medicine Saint Louis Missouri
United States Velocity Clinical Research, Savannah Neurology Specialists Savannah Georgia
United States UW Medicine MS Center Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Multicare Neuroscience Center of Washington Tacoma Washington
United States Vero Beach Neurology And Research Institute Vero Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Contineum Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment-emergent adverse events (TEAE) Number of participants with TEAEs From baseline to week 26 (end of treatment period)
Primary Change in binocular 2.5% low contrast letter acuity (LCLA) From baseline to week 26 (end-of-study)
Secondary Percentage of subjects with >/=5-letter gain in binocular 2.5% LCLA From baseline to week 26
Secondary Change in monocular 2.5% LCLA From baseline to week 26
Secondary Number of subjects with at least a 15% change in disability with the Timed 25-Foot Walk Test (T25WT) From baseline to week 26
Secondary Number of subjects with at least a 15% change in disability with the Nine-Hole Peg Test (9HPT) From baseline to week 26
Secondary Number of subjects with at least a 15% change in disability with the Symbol Digital Modality Test (SDMT) From baseline to week 26
Secondary Change in magnetic resonance imaging (MRI) measures of myelination and MS disease activity From baseline to week 26
Secondary Change in serum neurofilament light chain (NfL) From baseline to week 26
Secondary Pharmacokinetics: Change in blood concentration levels of PIPE-307 From baseline to week 30
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