Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
Public ClinicalTrials.gov record NCT07325292. 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, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07325292
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 160 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
- Jan 14, 2026 (Actual)
- Primary completion
- Jul 15, 2027 (Estimated)
- Completion
- Nov 30, 2028 (Estimated)
- Last update posted
- Oct 13, 2026
2026 – 2028
United States locations
- U.S. sites
- 34
- U.S. states
- 17
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Central Neurology Associates- Site Number : 8401100 | Cullman | Alabama | 35058 | Recruiting |
| Alabama Neurology Associates- Site Number : 8400115 | Homewood | Alabama | 35209 | Recruiting |
| Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195 | Phoenix | Arizona | 85032 | Recruiting |
| Perseverance Research Center- Site Number : 8400138 | Scottsdale | Arizona | 85253 | Recruiting |
| Center for Neurosciences - Tucson- Site Number : 8400194 | Tucson | Arizona | 85718 | Recruiting |
| Chemidox Clinical Trials- Site Number : 8401157 | Lancaster | California | 93534 | Recruiting |
| Private Practice - Dr. Regina Berkovich- Site Number : 8400005 | West Hollywood | California | 90048 | Recruiting |
| Rocky Mountain Regional VA Medical Center- Site Number : 8400121 | Aurora | Colorado | 80045 | Recruiting |
| Advanced Neurology of Colorado- Site Number : 8400148 | Fort Collins | Colorado | 80528 | Recruiting |
| Neurology of Central Florida- Site Number : 8400147 | Altamonte Springs | Florida | 32714 | Recruiting |
| Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054 | Gainesville | Florida | 32608 | Recruiting |
| Aqualane Clinical Research- Site Number : 8400026 | Naples | Florida | 34105 | Recruiting |
| Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060 | Orlando | Florida | 32806 | Recruiting |
| Neurology Associates of Ormond Beach- Site Number : 8400086 | Ormond Beach | Florida | 32174 | Recruiting |
| University of South Florida- Site Number : 8400013 | Tampa | Florida | 33612 | Recruiting |
| Palm Beach Neurology- Site Number : 8400105 | West Palm Beach | Florida | 33407 | Recruiting |
| Atlanta Neuroscience Institute- Site Number : 8400075 | Atlanta | Georgia | 30327 | Recruiting |
| Joi Life Wellness Group Llc- Site Number : 8400192 | Smyrna | Georgia | 30080 | Recruiting |
| Consultants in Neurology- Site Number : 8400020 | Northbrook | Illinois | 60062 | Recruiting |
| Baltimore Veterans Affairs Medical Center- Site Number : 8400163 | Baltimore | Maryland | 21201 | Recruiting |
| Neurology Center of New England- Site Number : 8400164 | Foxborough | Massachusetts | 02035 | Recruiting |
| Michigan Institute for Neurological Disorders- Site Number : 8400004 | Farmington Hills | Michigan | 48334 | Recruiting |
| Holy Name Medical Center- Site Number : 8400101 | Teaneck | New Jersey | 07666 | Recruiting |
| Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002 | Charlotte | North Carolina | 28210 | Recruiting |
| Raleigh Neurology Associates- Site Number : 8400014 | Raleigh | North Carolina | 27607 | Recruiting |
| The Ohio State University- Site Number : 8400009 | Columbus | Ohio | 43210 | Recruiting |
| The Boster Center for Multiple Sclerosis- Site Number : 8400006 | Columbus | Ohio | 43235 | Recruiting |
| Abington Neurological Associates- Site Number : 8401065 | Abington | Pennsylvania | 19001 | Recruiting |
| Hope Neurology- Site Number : 8400019 | Knoxville | Tennessee | 37922 | Recruiting |
| ANESC Research- Site Number : 8400187 | El Paso | Texas | 79912 | Recruiting |
| North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082 | Plano | Texas | 75024 | Recruiting |
| North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083 | Plano | Texas | 75024 | Recruiting |
| Neurology Center of San Antonio- Site Number : 8400099 | San Antonio | Texas | 78258 | Recruiting |
| Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038 | Milwaukee | Wisconsin | 53226 | Recruiting |
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 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07325292, 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 Oct 13, 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 NCT07325292 live on ClinicalTrials.gov.