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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIPE-307 Dose A | Experimental |
| |
| PIPE-307 Dose B | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIPE-307 Dose A | Drug | Subjects will receive daily oral doses of PIPE-307 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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:
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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| Name | Affiliation | Role |
|---|---|---|
| Stephen Huhn, MD | Contineum Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xenosciences | Phoenix | Arizona | 85004 | United States | ||
| Arizona Neuroscience Research, LLC |
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| PIPE-307 Dose B |
| Drug |
Subjects will receive daily oral doses of PIPE-307 |
|
| Placebo | Drug | Subjects will receive daily oral matching dose of Placebo |
|
| 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 |
| Change in magnetic resonance imaging (MRI) measures of myelination and MS disease activity | From baseline to week 26 |
| Change in serum neurofilament light chain (NfL) | From baseline to week 26 |
| Pharmacokinetics: Change in blood concentration levels of PIPE-307 | From baseline to week 30 |
| 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 |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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