129 Participants Needed

Ofatumumab + Siponimod vs Fingolimod for Pediatric Multiple Sclerosis

(NEOS Trial)

Recruiting at 94 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

This trial tests three medications in children and teens with multiple sclerosis to find effective treatments. The drugs work by reducing harmful immune cells or preventing them from attacking the nervous system.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Ofatumumab + Siponimod vs Fingolimod for Pediatric Multiple Sclerosis is an effective drug?

The available research shows that Fingolimod is an effective drug for treating pediatric multiple sclerosis. It has been approved for use in children with relapsing forms of the disease and has shown to reduce relapses significantly. However, there is no specific data provided on the combination of Ofatumumab + Siponimod for pediatric multiple sclerosis in the information available. Therefore, while Fingolimod is supported by research as effective, there is no direct comparison or data for Ofatumumab + Siponimod in the context of pediatric multiple sclerosis.12345

What data supports the effectiveness of the drug Fingolimod for pediatric multiple sclerosis?

Fingolimod has been shown to be effective in reducing relapses in children with relapsing-remitting multiple sclerosis, as confirmed by real-world data from two case reports. It was approved for use in children by the FDA and European Medicines Agency, demonstrating its effectiveness in this age group.12345

What safety data exists for Ofatumumab, Siponimod, and Fingolimod in treating pediatric multiple sclerosis?

The provided research does not contain safety data for Ofatumumab, Siponimod, or Fingolimod in the context of treating pediatric multiple sclerosis. The studies focus on antiemetic treatments for chemotherapy-induced nausea and vomiting, which are unrelated to the medications in question.678910

Is the drug Fingolimod, Ofatumumab, Siponimod a promising treatment for Pediatric Multiple Sclerosis?

Yes, Ofatumumab and Siponimod are promising drugs for treating multiple sclerosis. Ofatumumab is effective in reducing relapse rates and slowing disability progression, and it can be self-administered, offering convenience. Siponimod has shown significant benefits in slowing disease progression compared to other treatments. Both drugs have been shown to be effective in managing multiple sclerosis symptoms.1112131415

What makes the drug combination of Ofatumumab, Siponimod, and Fingolimod unique for treating pediatric multiple sclerosis?

This drug combination is unique because it combines Ofatumumab, a self-administered antibody targeting B-cells, with Siponimod, which slows disease progression, and Fingolimod, known for reducing relapse rates, offering a comprehensive approach to managing multiple sclerosis in children.1112131415

Research Team

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for children and teenagers aged 10 to less than 18 with multiple sclerosis (MS). They should have had at least one MS attack in the past year or two attacks in the last two years, or new brain lesions on MRI within a year. Those with progressive MS, other immune diseases, severe heart or kidney problems can't join.

Inclusion Criteria

I have had at least one MS flare-up in the last year or two in the last two years, or new brain lesions.
I am between 10 and 17 years old.

Exclusion Criteria

I have severe kidney problems.
Participants meeting the definition of ADEM
My MS is getting worse.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Part

24-month, double-blind, triple dummy, randomized, 3-arm active-controlled study in children/adolescent patients with Multiple Sclerosis

24 months
Regular visits as per study protocol

Extension Part

60-month open label treatment for patients who complete the Core Part of the study

60 months
Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Fingolimod
  • Ofatumumab
  • Siponimod
Trial OverviewThe study tests Ofatumumab and Siponimod against Fingolimod, all drugs for MS. Participants will be randomly assigned to receive either one of these drugs or their placebos to compare effectiveness and safety.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: siponimod - 0.5 mg, 1 mg or 2 mg/ placeboExperimental Treatment2 Interventions
Siponimod tablet administered orally once daily. Titration period, Day 1 to Day 6, first dose is either 0.1 mg or 0.25 mg up to daily dose of either 0.5 mg, 1 mg or 2 mg (depending on CYP2C9 genotype and body weight).
Group II: ofatumumab - 20 mg injection/ placeboExperimental Treatment2 Interventions
Ofatumumab as a solution for injection in an autoinjector containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for subcutaneous administration. A loading dose at Day1, Day 7 and Day 14 and then injections every 4 weeks/ 6 weeks (depending on patient's body weight).
Group III: fingolimod - 0.5 mg or 0.25 mg/ placeboActive Control2 Interventions
Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).

Fingolimod is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Gilenya for:
  • Relapsing forms of multiple sclerosis
🇺🇸
Approved in United States as Gilenya for:
  • Relapsing forms of multiple sclerosis
🇨🇦
Approved in Canada as Gilenya for:
  • Relapsing forms of multiple sclerosis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

Fingolimod is an effective oral treatment for relapsing forms of multiple sclerosis, showing significant reductions in relapse rates and MRI progression compared to placebo and other treatments like IFN-β.
While generally well tolerated, fingolimod can cause common side effects such as fatigue and headaches, and rare but serious risks like heart issues and infections, necessitating careful patient monitoring.
Overview and safety of fingolimod hydrochloride use in patients with multiple sclerosis.Ward, MD., Jones, DE., Goldman, MD.[2015]
Fingolimod (Gilenya®) has been approved for treating relapsing-remitting multiple sclerosis (MS) in children, with real-world data from two cases showing its effectiveness over more than 2 years of treatment.
The findings support the use of fingolimod as a viable therapeutic option for pediatric patients with active relapsing MS, highlighting its potential benefits in managing this condition.
Fingolimod as an effective therapeutic strategy for pediatric relapsing-remitting multiple sclerosis: two case reports.Zanetta, C., Filippi, M., Moiola, L.[2021]
Fingolimod (Gilenya) is the first oral disease-modifying treatment approved for patients with highly active relapsing-remitting multiple sclerosis, marking a significant advancement in MS therapy.
This new treatment offers a novel mechanism of action by modulating the immune system, which may improve patient outcomes compared to traditional therapies.
Fingolimod for multiple sclerosis.[2015]

References

Overview and safety of fingolimod hydrochloride use in patients with multiple sclerosis. [2015]
Fingolimod as an effective therapeutic strategy for pediatric relapsing-remitting multiple sclerosis: two case reports. [2021]
Fingolimod for multiple sclerosis. [2015]
Fingolimod for the treatment of relapsing multiple sclerosis. [2015]
Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. [2022]
Efficacy, Safety And Feasibility Of Antiemetic Prophylaxis With Fosaprepitant, Granisetron And Dexamethasone In Pediatric Patients With Hemato-Oncological Malignancies. [2022]
The role of netupitant and palonosetron in chemotherapy-induced nausea and vomiting. [2018]
Fosaprepitant (MK-0517): a neurokinin-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting. [2019]
Optimizing emetic control in children receiving antineoplastic therapy: beyond the guidelines. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of the Use of Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients. [2019]
Matching-adjusted indirect treatment comparison of siponimod and other disease modifying treatments in secondary progressive multiple sclerosis. [2021]
Ofatumumab: A Review in Relapsing Forms of Multiple Sclerosis. [2022]
[Over one year of B‑cell targeted therapy with Ofatumumab s.c.: first results of a prospective, patient-centered real-world observational study]. [2023]
14.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Ofatumumab - a new drug for the treatment of multiple sclerosis]. [2021]
Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension. [2023]