Frexalimab: Pharmaceutical form:Solution for injection-Route of administration:SC injection
Frexalimab: Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
MRI contrast-enhancing preparations: Route of administration:IV injection
This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment.
The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.
Study details include:
The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months.
The number of scheduled visits (Parts A and B) will be 17 for participants receiving frexalimab SC or IV, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.
| Facility | City | Region | Status |
|---|---|---|---|
| North Central Neurology Associates- Site Number : 8401100 | Cullman | Alabama | Recruiting |
| Alabama Neurology Associates- Site Number : 8400115 | Homewood | Alabama | Recruiting |
| Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195 | Phoenix | Arizona | Recruiting |
| Perseverance Research Center- Site Number : 8400138 | Scottsdale | Arizona | Recruiting |
| Private Practice - Dr. Regina Berkovich- Site Number : 8400005 | West Hollywood | California | Recruiting |
| Advanced Neurology of Colorado- Site Number : 8400148 | Fort Collins | Colorado | Recruiting |
| Neurology of Central Florida- Site Number : 8400147 | Altamonte Springs | Florida | Recruiting |
| Aqualane Clinical Research- Site Number : 8400026 | Naples | Florida | Recruiting |
| Neurology Associates of Ormond Beach- Site Number : 8400086 | Ormond Beach | Florida | Recruiting |
| Palm Beach Neurology- Site Number : 8400105 | West Palm Beach | Florida | Recruiting |
| Joi Life Wellness Group LLC- Site Number : 8400192 | Smyrna | Georgia | Recruiting |
| Consultants in Neurology- Site Number : 8400020 | Northbrook | Illinois | Recruiting |
| Baltimore Veterans Affairs Medical Center- Site Number : 8400163 | Baltimore | Maryland | Recruiting |
| Michigan Institute for Neurological Disorders- Site Number : 8400004 | Farmington Hills | Michigan | Recruiting |
| Holy Name Medical Center- Site Number : 8400101 | Teaneck | New Jersey | Recruiting |
| Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002 | Charlotte | North Carolina | Recruiting |
| Raleigh Neurology Associates- Site Number : 8400014 | Raleigh | North Carolina | Recruiting |
| The Ohio State University- Site Number : 8400009 | Columbus | Ohio | Recruiting |
| The Boster Center for Multiple Sclerosis- Site Number : 8400006 | Columbus | Ohio | Recruiting |
| Hope Neurology- Site Number : 8400019 | Knoxville | Tennessee | Recruiting |
| ANESC Research- Site Number : 8400187 | El Paso | Texas | Recruiting |
| North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082 | Plano | Texas | Recruiting |
| North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083 | Plano | Texas | Recruiting |
| Investigational Site Number : 0560001 | Bruges | Belgium | Recruiting |
| Investigational Site Number : 0560008 | Brussels | Belgium | Recruiting |
| Investigational Site Number : 0560006 | Ghent | Belgium | Recruiting |
| Investigational Site Number : 0560007 | Kortrijk | Belgium | Recruiting |
| Investigational Site Number : 0560005 | Overpelt | Belgium | Recruiting |
| Investigational Site Number : 1560005 | Beijing | China | Recruiting |
| Investigational Site Number : 1560004 | Chengdu | China | Recruiting |
| Investigational Site Number : 1561029 | Chengdu | China | Recruiting |
| Investigational Site Number : 1560010 | Jiazhuang | China | Recruiting |
| Investigational Site Number : 3800016 | Milan | Milano | Recruiting |
| Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia Site Number : 3800019 | Foggia | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-Medico Site Number : 3800038 | Roma | Italy | Recruiting |
| Azienda Ospedaliera San Camillo Forlanini Site Number : 3800001 | Roma | Italy | Recruiting |
| Investigational Site Number : 3920017 | Sapporo | Hokkaido | Recruiting |
| Investigational Site Number : 3920008 | Yahaba | Iwate | Recruiting |
| Investigational Site Number : 3920001 | Kyoto | Japan | Recruiting |
| Investigational Site Number : 3920012 | Tokyo | Japan | Recruiting |
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 NCT07325292 on ClinicalTrials.gov ↗ ← All trials in the USA