Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Public ClinicalTrials.gov record NCT06141486. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06141486
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 943 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 27, 2023 (Actual)
- Primary completion
- Mar 24, 2028 (Estimated)
- Completion
- Mar 24, 2028 (Estimated)
- Last update posted
- May 14, 2026
2023 – 2028
United States locations
- U.S. sites
- 79
- U.S. states
- 36
- U.S. cities
- 71
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Neurology Associates- Site Number : 8400115 | Homewood | Alabama | 35209 | — |
| Perseverance Research Center- Site Number : 8400138 | Scottsdale | Arizona | 85253 | — |
| Imaging Endpoints- Site Number : 8400050 | Scottsdale | Arizona | 85258 | — |
| Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134 | Berkeley | California | 94705 | — |
| University of California Irvine - School of Medicine- Site Number : 8400143 | Irvine | California | 92697 | — |
| University of California San Diego - La Jolla- Site Number : 8400095 | La Jolla | California | 92037 | — |
| Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184 | Los Angeles | California | 90027 | — |
| Hoag Memorial Hospital Presbyterian- Site Number : 8400031 | Newport Beach | California | 92663 | — |
| Stanford Neuroscience Health Center- Site Number : 8400120 | Palo Alto | California | 94304 | — |
| Private Practice - Dr. Regina Berkovich- Site Number : 8400005 | West Hollywood | California | 90048 | — |
| University of Colorado - Anschutz Medical Campus- Site Number : 8400001 | Aurora | Colorado | 80045 | — |
| Advanced Neurology of Colorado- Site Number : 8400148 | Fort Collins | Colorado | 80528 | — |
| Yale University School of Medicine- Site Number : 8400081 | New Haven | Connecticut | 06510 | — |
| Hartford Healthcare Medical Group- Site Number : 8400069 | Norwich | Connecticut | 06360 | — |
| MedStar Georgetown University Hospital- Site Number : 8400044 | Washington D.C. | District of Columbia | 20007 | — |
| Neurology of Central Florida- Site Number : 8400147 | Altamonte Springs | Florida | 32714 | — |
| MS & Neuromuscular Center of Excellence- Site Number : 8400015 | Clearwater | Florida | 33761 | — |
| Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054 | Gainesville | Florida | 32608 | — |
| Neurology Associates - Maitland- Site Number : 8400010 | Maitland | Florida | 32751 | — |
| Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060 | Orlando | Florida | 32806 | — |
| Axiom Clinical Research of Florida- Site Number : 8400049 | Tampa | Florida | 33609 | — |
| University of South Florida- Site Number : 8400013 | Tampa | Florida | 33612 | — |
| Palm Beach Neurology- Site Number : 8400105 | West Palm Beach | Florida | 33407 | — |
| Joi Life Wellness Group LLC- Site Number : 8400192 | Smyrna | Georgia | 30080 | — |
| Rush University Medical Center- Site Number : 8400102 | Chicago | Illinois | 60612 | — |
| University of Chicago Medical Center- Site Number : 8400055 | Chicago | Illinois | 60637 | — |
| Consultants in Neurology- Site Number : 8400020 | Northbrook | Illinois | 60062 | — |
| Neuroscience Institute Center- Site Number : 8400053 | Merrillville | Indiana | 46410 | — |
| University of Iowa- Site Number : 8400029 | Iowa City | Iowa | 52242-1009 | — |
| University of Kansas Medical Center- Site Number : 8400084 | Kansas City | Kansas | 66103 | — |
| Baptist Health Lexington- Site Number : 8400149 | Lexington | Kentucky | 40503 | — |
| NeuroMedical Clinic of Central Louisiana- Site Number : 8400159 | Alexandria | Louisiana | 71301 | — |
| Ochsner Medical Center - Jefferson Highway- Site Number : 8400027 | New Orleans | Louisiana | 70121 | — |
| University of Maryland School of Medicine - Baltimore- Site Number : 8400185 | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hospital- Site Number : 8400080 | Baltimore | Maryland | 21287 | — |
| Tufts Medical Center- Site Number : 8400003 | Boston | Massachusetts | 02111 | — |
| Boston Clinical Trials- Site Number : 8400178 | Boston | Massachusetts | 02131 | — |
| Neurology Center of New England- Site Number : 8400164 | Foxborough | Massachusetts | 02035 | — |
| The Elliot Lewis Center- Site Number : 8400033 | Wellesley | Massachusetts | 02481 | — |
| UMass Memorial Medical Center - University Campus- Site Number : 8400028 | Worcester | Massachusetts | 01655 | — |
| Henry Ford Hospital- Site Number : 8400091 | Detroit | Michigan | 48202 | — |
| Michigan Institute for Neurological Disorders- Site Number : 8400004 | Farmington Hills | Michigan | 48334 | — |
| Trinity Health Grand Rapids- Site Number : 8400150 | Grand Rapids | Michigan | 49503 | — |
| Memorial Healthcare Institute for Neuroscience- Site Number : 8400123 | Owosso | Michigan | 48867 | — |
| Rochester Medical Group- Site Number : 8400172 | Rochester Hills | Michigan | 48307 | — |
| Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400077 | Golden Valley | Minnesota | 55422 | — |
| M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056 | Minneapolis | Minnesota | 55455 | — |
| Minnesota Center for Multiple Sclerosis- Site Number : 8400073 | Plymouth | Minnesota | 55446 | — |
| Sharlin Health and Neurology- Site Number : 8400016 | Ozark | Missouri | 65721 | — |
| Washington University- Site Number : 8400076 | St Louis | Missouri | 63110 | — |
| Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045 | Las Vegas | Nevada | 89106 | — |
| Renown Regional Medical Center- Site Number : 8400066 | Reno | Nevada | 89502 | — |
| Holy Name Medical Center- Site Number : 8400101 | Teaneck | New Jersey | 07666 | — |
| The University of New Mexico- Site Number : 8400090 | Albuquerque | New Mexico | 87106 | — |
| Dent Neurologic Institute - Amherst- Site Number : 8400129 | Amherst | New York | 14226 | — |
| Icahn School of Medicine at Mount Sinai- Site Number : 8400011 | New York | New York | 10029 | — |
| Columbia University Irving Medical Center- Site Number : 8400088 | New York | New York | 10032 | — |
| Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002 | Charlotte | North Carolina | 28210 | — |
| Raleigh Neurology Associates- Site Number : 8400014 | Raleigh | North Carolina | 27607 | — |
| Atrium Health - Wake Forest Baptist - Shepherd- Site Number : 8400040 | Winston-Salem | North Carolina | 27103 | — |
| Sanford Brain and Spine Center- Site Number : 8400085 | Fargo | North Dakota | 58103 | — |
| Riverhills Neuroscience- Site Number : 8400007 | Cincinnati | Ohio | 45212 | — |
| University of Cincinnati Medical Center- Site Number : 8400117 | Cincinnati | Ohio | 45219 | — |
| The Ohio State University- Site Number : 8400009 | Columbus | Ohio | 43210 | — |
| The Boster Center for Multiple Sclerosis- Site Number : 8400006 | Columbus | Ohio | 43235 | — |
| UC Health - Elizabeth Place- Site Number : 8400008 | Dayton | Ohio | 45408 | — |
| Oklahoma Medical Research Foundation- Site Number : 8400039 | Oklahoma City | Oklahoma | 73104 | — |
| Providence St. Vincent's Medical Center- Site Number : 8400052 | Portland | Oregon | 97225 | — |
| Penn State Health Milton South Hershey Medical Center- Site Number : 8400176 | Hershey | Pennsylvania | 17033 | — |
| Premier Neurology- Site Number : 8400047 | Greer | South Carolina | 29650 | — |
| Vanderbilt Multiple Sclerosis Center- Site Number : 8400130 | Nashville | Tennessee | 37215 | — |
| Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152 | Dallas | Texas | 75243 | — |
| North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083 | Plano | Texas | 75024 | — |
| Neurology Center of San Antonio- Site Number : 8400099 | San Antonio | Texas | 78258 | — |
| Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018 | Sherman | Texas | 75092 | — |
| University of Vermont Medical Center- Site Number : 8400042 | Burlington | Vermont | 05401 | — |
| Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8400109 | Fairfax | Virginia | 22031 | — |
| Swedish Medical Center - Seattle- Site Number : 8400078 | Seattle | Washington | 98104 | — |
| Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 232 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06141486, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 14, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06141486 live on ClinicalTrials.gov.