Ofatumumab for Early Relapsing-Remitting Multiple Sclerosis
(AGNOS Trial)
Trial Summary
What is the purpose of this trial?
This study will evaluate the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study will also assess changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.
Will I have to stop taking my current medications?
The trial requires that participants have not used any Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS before joining. If you are currently on these medications, you would need to stop them to participate.
What data supports the effectiveness of the drug Ofatumumab for treating early relapsing-remitting multiple sclerosis?
How is the drug Ofatumumab different from other treatments for relapsing-remitting multiple sclerosis?
Ofatumumab is unique because it is a fully human anti-CD20 monoclonal antibody that can be self-administered as a subcutaneous injection, offering convenience and independence from hospital visits. It targets a different region on the CD20 receptor compared to other similar drugs, leading to efficient B-cell depletion and has shown to be more effective than some existing treatments like teriflunomide in reducing relapse rates and disability progression.34567
Eligibility Criteria
This trial is for young adults aged 18-35 with very early Relapsing Remitting Multiple Sclerosis (RRMS), diagnosed within the last 6 months and who haven't started any MS treatments. Participants must be able to use a wearable device, provide blood samples, and undergo MRI scans. Pregnant women, those with other immune diseases or infections, previous MS treatments, or severe kidney issues can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 20 mg ofatumumab subcutaneously monthly for 18 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ofatumumab
Ofatumumab is already approved in European Union, United States for the following indications:
- Relapsing forms of multiple sclerosis (MS)
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
- Relapsing forms of multiple sclerosis (MS)
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
- Certain types of chronic lymphocytic leukemia (CLL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD