Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (NEOS)
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| ClinicalTrials.gov Identifier: NCT04926818 |
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Recruitment Status :
Recruiting
First Posted : June 15, 2021
Last Update Posted : January 17, 2023
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis (MS) | Drug: Fingolimod Drug: Ofatumumab Drug: Siponimod Other: Fingolimod placebo Other: Siponimod placebo Other: Ofatumumab placebo | Phase 3 |
The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 180 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | The core part of the study and the first 12 weeks of the extension period (transition) will be double-blinded and the remainder of the extension period will be open label. |
| Primary Purpose: | Treatment |
| Official Title: | A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension |
| Actual Study Start Date : | October 5, 2021 |
| Estimated Primary Completion Date : | August 4, 2026 |
| Estimated Study Completion Date : | June 1, 2029 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: ofatumumab - 20 mg injection/ placebo
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).
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Drug: Ofatumumab
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).
Other Name: OMB157 Other: Ofatumumab placebo Ofatumumab matching placebo autoinjector |
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Experimental: siponimod - 0.5 mg, 1 mg or 2 mg/ placebo
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).
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Drug: Siponimod
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).
Other Name: BAF312 Other: Siponimod placebo Siponimod matching placebo tablet |
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Active Comparator: fingolimod - 0.5 mg or 0.25 mg/ placebo
Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).
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Drug: Fingolimod
Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).
Other Name: FTY720 Other: Fingolimod placebo Fingolimod matching placebo capsule |
Primary Outcome Measures :
- Annualized relapse rate (ARR) in target pediatric participants [ Time Frame: Baseline up to 24 months ]Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
Secondary Outcome Measures :
- Annualized relapse rate (ARR) as compared to historical interferon β-1a data [ Time Frame: Baseline up to 24 months ]Frequency of relapses assessed by the annualized relapse rate (ARR) to historical interferon β-1a data. The ARR is defined as the average number of confirmed relapses per year. The historical data for interferon β-1a will derived from prior phase 3 studies.
- Annualized T2 lesion rate [ Time Frame: Baseline up to 24 months ]Number of new/newly enlarged T2 lesions per year
- Neurofilament light chain (NfL) concentrations [ Time Frame: Day 1, Months 3,6,12,18,24 ]Neurofilament light chain (NfL) concentration in serum of ofatumumab and/or siponimod versus fingolimod
- Plasma Concentrations of ofatumumab [ Time Frame: Day 1, pre-dose for Day 7, Months 2,3,5,6,12,18,24 ]Ofatumumab plasma concentrations
- Plasma Concentrations of siponimod [ Time Frame: Day 1 (2,3,4,6 h), Day 3 (2,3,4,6 h), pre-dose for Months 1 (pre, 3h), 3,5,12 ]Siponimod plasma concentrations
- Plasma Concentrations of siponimod metabolite (M17) [ Time Frame: Pre-dose Month 3, 5 and Month 12 ]Siponimod metabolite (M17) plasma concentration
- Percentage of participants with anti-ofatumumab antibodies [ Time Frame: Day 1, Pre-Dose Months 2,3,5,6,12,18,24 ]Anti-ofatumumab antibodies to demonstrate immunogenicity of ofatumumab
- Number of adverse events and serious adverse events [ Time Frame: Baseline up approximately 66 months ]Any clinically relevant finding that meets the criteria of an adverse event (as determined by the investigator) identified during the safety assessments (ECG, laboratory and ophthalmological data, pulmonary function tests and vital signs) will be reported as an adverse event
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| Ages Eligible for Study: | 10 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
- Diagnosis of multiple sclerosis
- EDSS score of 0 to 5.5, inclusive
- At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months
Exclusion Criteria:
- Participants with progressive MS
- Participants with an active, chronic disease of the immune system other than MS
- Participants meeting the definition of ADEM
- Participants with severe cardiac disease or significant findings on the screening ECG.
- Participants with severe renal insufficiency
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926818
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
| Contact: Novartis Pharmaceuticals | +41613241111 |
Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04926818 |
| Other Study ID Numbers: |
CBAF312D2301 |
| First Posted: | June 15, 2021 Key Record Dates |
| Last Update Posted: | January 17, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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relapsing multiple sclerosis pediatric relapse EDSS ofatumumab |
siponimod fingolimod RMS MS |
Additional relevant MeSH terms:
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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Ofatumumab |
Antibodies, Monoclonal Fingolimod Hydrochloride Siponimod Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Sphingosine 1 Phosphate Receptor Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents |