Frexalimab: SAR441344 Solution for IV infusion
Placebo: Solution for IV infusion
MRI contrast-enhancing agents: IV, as per respective label
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include:
* This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end.
* The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.
* If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Neurology Associates- Site Number : 8400115 | Homewood | Alabama | |
| Perseverance Research Center- Site Number : 8400138 | Scottsdale | Arizona | |
| Imaging Endpoints- Site Number : 8400050 | Scottsdale | Arizona | |
| Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134 | Berkeley | California | |
| University of California Irvine - School of Medicine- Site Number : 8400143 | Irvine | California | |
| University of California San Diego - La Jolla- Site Number : 8400095 | La Jolla | California | |
| Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184 | Los Angeles | California | |
| Hoag Memorial Hospital Presbyterian- Site Number : 8400031 | Newport Beach | California | |
| Stanford Neuroscience Health Center- Site Number : 8400120 | Palo Alto | California | |
| Private Practice - Dr. Regina Berkovich- Site Number : 8400005 | West Hollywood | California | |
| University of Colorado - Anschutz Medical Campus- Site Number : 8400001 | Aurora | Colorado | |
| Advanced Neurology of Colorado- Site Number : 8400148 | Fort Collins | Colorado | |
| Yale University School of Medicine- Site Number : 8400081 | New Haven | Connecticut | |
| Hartford Healthcare Medical Group- Site Number : 8400069 | Norwich | Connecticut | |
| MedStar Georgetown University Hospital- Site Number : 8400044 | Washington D.C. | District of Columbia | |
| Neurology of Central Florida- Site Number : 8400147 | Altamonte Springs | Florida | |
| MS & Neuromuscular Center of Excellence- Site Number : 8400015 | Clearwater | Florida | |
| Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054 | Gainesville | Florida | |
| Neurology Associates - Maitland- Site Number : 8400010 | Maitland | Florida | |
| Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060 | Orlando | Florida | |
| Axiom Clinical Research of Florida- Site Number : 8400049 | Tampa | Florida | |
| University of South Florida- Site Number : 8400013 | Tampa | Florida | |
| Palm Beach Neurology- Site Number : 8400105 | West Palm Beach | Florida | |
| Joi Life Wellness Group LLC- Site Number : 8400192 | Smyrna | Georgia | |
| Rush University Medical Center- Site Number : 8400102 | Chicago | Illinois | |
| University of Chicago Medical Center- Site Number : 8400055 | Chicago | Illinois | |
| Consultants in Neurology- Site Number : 8400020 | Northbrook | Illinois | |
| Neuroscience Institute Center- Site Number : 8400053 | Merrillville | Indiana | |
| University of Iowa- Site Number : 8400029 | Iowa City | Iowa | |
| University of Kansas Medical Center- Site Number : 8400084 | Kansas City | Kansas | |
| Baptist Health Lexington- Site Number : 8400149 | Lexington | Kentucky | |
| NeuroMedical Clinic of Central Louisiana- Site Number : 8400159 | Alexandria | Louisiana | |
| Ochsner Medical Center - Jefferson Highway- Site Number : 8400027 | New Orleans | Louisiana | |
| University of Maryland School of Medicine - Baltimore- Site Number : 8400185 | Baltimore | Maryland | |
| Johns Hopkins Hospital- Site Number : 8400080 | Baltimore | Maryland | |
| Tufts Medical Center- Site Number : 8400003 | Boston | Massachusetts | |
| Boston Clinical Trials- Site Number : 8400178 | Boston | Massachusetts | |
| Neurology Center of New England- Site Number : 8400164 | Foxborough | Massachusetts | |
| The Elliot Lewis Center- Site Number : 8400033 | Wellesley | Massachusetts | |
| UMass Memorial Medical Center - University Campus- Site Number : 8400028 | Worcester | Massachusetts |
+ 271 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06141486 on ClinicalTrials.gov ↗ ← All trials in the UK