A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)
Study compares Ofatumumab to current MS treatments after biomarker elevation
Plain English Summary
A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation is a Phase 4 clinical trial sponsored by Novartis Pharmaceuticals studying Relapsing-Remitting Multiple Sclerosis. This study tests if switching to Ofatumumab is better than staying on current treatment for relapsing-remitting MS patients whose blood test shows elevated neurofilament light. It is for adults aged 18-45 diagnosed with relapsing-remitting MS who are stable on their current treatment but have a specific biomarker indicating potential for future disease activity. Participation involves regular study visits, MRI scans, blood tests, and potentially using a wearable device, while continuing current treatment or switching to Ofatumumab. Alternatives include continuing the current disease-modifying therapy (DMT) without switching, or exploring other approved DMTs outside of this trial. The trial aims to enroll 136 participants.
Official Summary
This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 45 years old, have relapsing-remitting MS diagnosed by specific criteria, and have a disability score between 0 and 5.5. You must have been on your current MS treatment for at least 6 months with no relapses in the last 6 months. You cannot join if you have a different form of MS (like progressive MS), other neurological conditions, active infections, or a history of certain cancers or immune system diseases. You also cannot join if you have had experimental MS drugs in the last 2 years or have known sensitivity to MRI contrast agents. This trial is studying Relapsing-Remitting Multiple Sclerosis, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures whether patients achieve 'No Evidence of Disease Activity' (NEDA-3), meaning no new relapses, no new MRI lesions, and no worsening of disability, which indicates the treat The specific primary outcome measures are: Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3) (Months 3 to 15). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial addresses a gap in managing relapsing-remitting MS by investigating if a specific biomarker (elevated neurofilament light) can predict which patients might benefit from switching to Ofatumu This research targets Relapsing-Remitting Multiple Sclerosis, where improved treatment options are needed.
Investor Insight
This trial, sponsored by Novartis, explores the use of Ofatumumab in a specific patient subgroup, potentially expanding its market share in the competitive MS treatment landscape, with a moderate prob This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor if your elevated neurofilament light level means switching treatment could be beneficial for you. Understand that participation requires regular visits for monitoring, which may include MRI scans and blood draws. Be prepared for potential use of a wearable device to track certain health metrics as part of the study. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 136 participants
Interventions
- DRUG: Ofatumumab — 3 loading doses followed by administration every 4 weeks as per label
- DRUG: Disease modifying treatment (DMT) — Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening
Primary Outcomes
- Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3) (Months 3 to 15)
Secondary Outcomes
- Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml achieving NEDA-3 (No Evidence of Disease Activity-3) (Months 3 to15)
- Annualized relapse rate in Months 3 to 15 (Months 3 to 15)
- Percentage of participants without a worsening of their disability (Months 3 to 15)
- Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical (Months 3 to 15)
- Percentage of participants with NEDA (No Evidence of Disease Activity) - Radiological (Months 3 to 15)
Full Eligibility Criteria
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Age 18-45 years * Diagnosis of RRMS per McDonald Criteria (2017) * EDSS 0-5.5 (Inclusive) * Able to obtain MRI and attend study visits at sites * Willing to use wearable device as specified in the protocol * Able to provide blood sample * On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening * No relapse reported within 6 months prior to Screening * Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary. Exclusion Criteria: * Primary progressive or secondary progressive phenotype * Diseases other than multiple sclerosis responsible for the clinical or MRI presentation * Use of experimental or investigational drugs for MS within 2 years from Screening * Known sensitivity to gadolinium * Central Nervous System (CNS) anomalies that are better accounted for by another disease process * Known active malignancies * Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS * Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies * Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML * IgG or IgM levels below lower limit of normal (LLN) at Screening
Trial Locations
- Alabama Neurology Associates PC, Birmingham, Alabama, United States
- North Central Neurology Associates PC, Cullman, Alabama, United States
- Radiant Research Chandler, Chandler, Arizona, United States
- Arizona Neuroscience Research LLC, Phoenix, Arizona, United States
- University of California at Los Angeles, Torrance, California, United States
- Neurology of Central FL Res Ctr, Altamonte Springs, Florida, United States
- S And D Clinical Research, Cape Coral, Florida, United States
- Homestead Assoc In Research Inc, Homestead, Florida, United States
- Neurology Associates PA, Maitland, Florida, United States
- Orlando Health Clinical Trials, Orlando, Florida, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT05090371?
NCT05090371 is a Phase 4 INTERVENTIONAL study titled "A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation." It is currently active, not recruiting and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 136 participants.
What conditions does NCT05090371 study?
This trial investigates treatments for Relapsing-Remitting Multiple Sclerosis. The primary condition under study is Relapsing-Remitting Multiple Sclerosis.
What treatments are being tested in NCT05090371?
The interventions being studied include: Ofatumumab (DRUG), Disease modifying treatment (DMT) (DRUG). 3 loading doses followed by administration every 4 weeks as per label
What does Phase 4 mean for NCT05090371?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT05090371?
This trial is currently "Active, Not Recruiting." It started on 2022-03-02. The estimated completion date is 2027-04-13.
Who is sponsoring NCT05090371?
NCT05090371 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05090371?
The trial aims to enroll 136 participants. The trial status is active, not recruiting.
How is NCT05090371 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05090371?
The primary outcome measures are: Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3) (Months 3 to 15). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05090371 being conducted?
This trial is being conducted at 20 sites, including Birmingham, Alabama; Cullman, Alabama; Chandler, Arizona; Phoenix, Arizona and 16 more sites (United States).
Where can I find official information about NCT05090371?
The official record for NCT05090371 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05090371. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05090371 testing in simple terms?
This study tests if switching to Ofatumumab is better than staying on current treatment for relapsing-remitting MS patients whose blood test shows elevated neurofilament light. It is for adults aged 18-45 diagnosed with relapsing-remitting MS who are stable on their current treatment but have a specific biomarker indicating potential for future disease activity.
Why is this trial significant?
This trial addresses a gap in managing relapsing-remitting MS by investigating if a specific biomarker (elevated neurofilament light) can predict which patients might benefit from switching to Ofatumu
What are the potential risks of participating in NCT05090371?
The main risks are related to the treatments being studied, including potential side effects of Ofatumumab such as infections or infusion reactions. Continuing current therapy may carry risks associated with the known side effects of those specific medications. MRI scans involve contrast agents which carry a small risk for those with known sensitivity. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05090371?
Ask your doctor if your elevated neurofilament light level means switching treatment could be beneficial for you. Understand that participation requires regular visits for monitoring, which may include MRI scans and blood draws. Be prepared for potential use of a wearable device to track certain health metrics as part of the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05090371 signal from an investment perspective?
This trial, sponsored by Novartis, explores the use of Ofatumumab in a specific patient subgroup, potentially expanding its market share in the competitive MS treatment landscape, with a moderate prob This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves regular study visits, MRI scans, blood tests, and potentially using a wearable device, while continuing current treatment or switching to Ofatumumab. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.