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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04926818




Registration number
NCT04926818
Ethics application status
Date submitted
14/06/2021
Date registered
15/06/2021

Titles & IDs
Public title
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
Scientific 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
Secondary ID [1] 0 0
CBAF312D2301
Universal Trial Number (UTN)
Trial acronym
NEOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis (MS) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod
Treatment: Drugs - Ofatumumab
Treatment: Drugs - Siponimod
Other interventions - Fingolimod placebo
Other interventions - Siponimod placebo
Other interventions - Ofatumumab placebo

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).

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).

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).


Treatment: Drugs: 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).

Treatment: Drugs: 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).

Treatment: Drugs: 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 interventions: Fingolimod placebo
Fingolimod matching placebo capsule

Other interventions: Siponimod placebo
Siponimod matching placebo tablet

Other interventions: Ofatumumab placebo
Ofatumumab matching placebo autoinjector
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized relapse rate (ARR) in target pediatric participants
Timepoint [1] 0 0
Baseline up to 24 months
Secondary outcome [1] 0 0
Annualized relapse rate (ARR) as compared to historical interferon ß-1a data
Timepoint [1] 0 0
Baseline up to 24 months
Secondary outcome [2] 0 0
Annualized T2 lesion rate
Timepoint [2] 0 0
Baseline up to 24 months
Secondary outcome [3] 0 0
Neurofilament light chain (NfL) concentrations
Timepoint [3] 0 0
Day 1, Months 3,6,12,18,24
Secondary outcome [4] 0 0
Plasma Concentrations of ofatumumab
Timepoint [4] 0 0
Day 1, pre-dose for Day 7, Months 2,3,5,6,12,18,24
Secondary outcome [5] 0 0
Plasma Concentrations of siponimod
Timepoint [5] 0 0
Day 1 (2,3,4,6 h), Day 3 (2,3,4,6 h), pre-dose for Months 1 (pre, 3h), 3,5,12
Secondary outcome [6] 0 0
Plasma Concentrations of siponimod metabolite (M17)
Timepoint [6] 0 0
Pre-dose Month 3, 5 and Month 12
Secondary outcome [7] 0 0
Percentage of participants with anti-ofatumumab antibodies
Timepoint [7] 0 0
Day 1, Pre-Dose Months 2,3,5,6,12,18,24
Secondary outcome [8] 0 0
Number of adverse events and serious adverse events
Timepoint [8] 0 0
Baseline up approximately 66 months

Eligibility
Key inclusion criteria
1. Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
2. Diagnosis of multiple sclerosis
3. EDSS score of 0 to 5.5, inclusive
4. 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
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with progressive MS
2. Participants with an active, chronic disease of the immune system other than MS
3. Participants meeting the definition of ADEM
4. Participants with severe cardiac disease or significant findings on the screening ECG.
5. Participants with severe renal insufficiency

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/12/2031
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
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United States of America
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Arkansas
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California
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District of Columbia
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Florida
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Georgia
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Kentucky
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Minnesota
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Missouri
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Oregon
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Pennsylvania
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Texas
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Utah
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West Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Austria
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Vienna
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Belgium
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Esneux
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Belgium
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Gent
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Brazil
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PR
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Brazil
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RS
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Brazil
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SP
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago
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Croatia
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Zagreb
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Estonia
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Tallinn
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France
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Le Kremlin Bicetre
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France
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Montpellier
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Erlangen
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Germany
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Freiburg
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Germany
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Gottingen
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Guatemala
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Guatemala
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India
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Delhi
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India
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Kerala
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India
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Uttar Pradesh
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India
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West Bengal
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Israel
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Petach Tikva
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Italy
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MI
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Italy
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RM
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Italy
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Napoli
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Latvia
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Riga
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Mexico
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Distrito Federal
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Mexico
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Gdansk
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Lodz
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Poznan
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Warsaw
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Portugal
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Coimbra
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Portugal
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Lisboa
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Romania
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Bucuresti
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Russian Federation
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St Petersburg
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Serbia
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Belgrade
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Slovakia
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Bratislava
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Andalucia
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Asturias
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Spain
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Vizcaya
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Spain
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Madrid
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
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TUR
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Samsun
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04926818