An Open-label, Randomized, Parallel Group, Non-inferiority Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab, Followed by Extended Treatment in Participants With Relapsing Multiple Sclerosis
New Ofatumumab Dosing Regimen for MS
Plain English Summary
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab is a Phase 3 clinical trial sponsored by Novartis Pharmaceuticals studying Relapsing Multiple Sclerosis (RMS). Tests a new dose of Ofatumumab for managing relapsing multiple sclerosis. For adults aged 18-60 with relapsing MS, including RRMS and active SPMS. Participation involves regular clinic visits and blood tests. Alternative treatments include other MS drugs like ocrelizumab and rituximab. The trial aims to enroll 196 participants.
Official Summary
This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.
Who Can Participate
Here is what you need to know about eligibility for this trial. Ages 18-60, diagnosed with relapsing MS. Excludes those with active infections, malignancies, or other immune diseases. Must be able to understand and follow study instructions. Pregnant or nursing women are not eligible. This trial is studying Relapsing Multiple Sclerosis (RMS), so participants generally need a confirmed diagnosis.
What They're Measuring
Measures include drug levels in the blood and side effects, helping patients understand how the drug works and its safety. The specific primary outcome measures are: Ofatumumab plasma pharmacokinetics - area under the curve (Up to 12 weeks). 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 trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to improve MS management by evaluating a new dose of Ofatumumab, addressing gaps in current treatment options. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Relapsing Multiple Sclerosis (RMS), where improved treatment options are needed.
Investor Insight
Largest MS market, with strong competition; approval is likely given the need for new treatment options. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor about your MS type and if you meet age criteria. Expect regular clinic visits and blood tests over 52 weeks. 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: 196 participants
Interventions
- BIOLOGICAL: Ofatumumab approved dose — Approved dosage
- BIOLOGICAL: Ofatumumab new dose — New dosage
Primary Outcomes
- Ofatumumab plasma pharmacokinetics - area under the curve (Up to 12 weeks)
Secondary Outcomes
- Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration (Up to 12 weeks)
- Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration (Up to 12 weeks)
- Incidence of Adverse events (AE) and Serious adverse events (SAE) (Up to 52 weeks)
- Proportion of participants with anti-drug antibodies (Up to 52 weeks)
- Participant B cell counts (Up to 52 weeks)
Full Eligibility Criteria
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female study participants aged 18 to 60 years (inclusive) at screening. * Diagnosis of multiple sclerosis (MS) according to the 2017 Revised McDonald criteria (Thompson et al 2018). Relapsing forms of MS: relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS). Exclusion Criteria: * Participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator or emergence of any clinically significant condition/disease (e.g. active systemic bacterial, viral or fungal infections) during screening prior to Day 1 which might result in safety risk for participants. * Participants with history of confirmed progressive multifocal leukoencephalopathy (PML) or neurological symptoms consistent with PML. * Participants at risk of developing or having reactivation of hepatitis * Emergence of active chronic disease (or stable but treated with immune therapy) prior to Day 1 of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency). * Pregnant or nursing (lactating) women * History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma, or squamous cell carcinomas of the skin that have been treated with no evidence of recurrence in the past 3 months). * Participants taking prohibited therapies, including B cell targeted therapies (e.g. such as ocrelizumab, rituximab, ofatumumab, ublituximab, and inebilizumab) Other protocol-defined inclusion/exclusion criteria may apply
Trial Locations
- Alabama Neurology Associates PC, Birmingham, Alabama, United States
- Xenoscience Inc, Phoenix, Arizona, United States
- Ctr for Neurology and Spine, Phoenix, Arizona, United States
- Phoenix Neurological Associates, Phoenix, Arizona, United States
- The Research and Education Inst. of Alta Bates Summit Med. Grp, Berkeley, California, United States
- Fullerton Neuro and Headache Ctr, Fullerton, California, United States
- University of California Irvine, Irvine, California, United States
- CenExcel Clinical Research, Los Alamitos, California, United States
- Velocity Clinical Trials, Los Angeles, California, United States
- Regina Berkovich MD PhD Inc, West Hollywood, California, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06869785?
NCT06869785 is a Phase 3 INTERVENTIONAL study titled "Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab." It is currently active, not recruiting and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 196 participants.
What conditions does NCT06869785 study?
This trial investigates treatments for Relapsing Multiple Sclerosis (RMS). The primary condition under study is Relapsing Multiple Sclerosis (RMS).
What treatments are being tested in NCT06869785?
The interventions being studied include: Ofatumumab approved dose (BIOLOGICAL), Ofatumumab new dose (BIOLOGICAL). Approved dosage
What does Phase 3 mean for NCT06869785?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06869785?
This trial is currently "Active, Not Recruiting." It started on 2025-03-13. The estimated completion date is 2030-03-23.
Who is sponsoring NCT06869785?
NCT06869785 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06869785?
The trial aims to enroll 196 participants. The trial status is active, not recruiting.
How is NCT06869785 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06869785?
The primary outcome measures are: Ofatumumab plasma pharmacokinetics - area under the curve (Up to 12 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06869785 being conducted?
This trial is being conducted at 20 sites, including Birmingham, Alabama; Phoenix, Arizona; Berkeley, California; Fullerton, California and 16 more sites (United States).
Where can I find official information about NCT06869785?
The official record for NCT06869785 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06869785. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06869785 testing in simple terms?
Tests a new dose of Ofatumumab for managing relapsing multiple sclerosis. For adults aged 18-60 with relapsing MS, including RRMS and active SPMS.
Why is this trial significant?
This trial aims to improve MS management by evaluating a new dose of Ofatumumab, addressing gaps in current treatment options. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06869785?
Potential side effects include injection site reactions and infections. Monitor for any unusual symptoms and report them to your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06869785?
Ask your doctor about your MS type and if you meet age criteria. Expect regular clinic visits and blood tests over 52 weeks. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06869785 signal from an investment perspective?
Largest MS market, with strong competition; approval is likely given the need for new treatment options. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves regular clinic visits and blood tests. 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.
Related Conditions
More Relapsing Multiple Sclerosis (RMS) Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.