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Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (NEOS)

Primary Purpose

Multiple Sclerosis (MS)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fingolimod
Ofatumumab
Siponimod
Fingolimod placebo
Siponimod placebo
Ofatumumab placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis (MS) focused on measuring relapsing multiple sclerosis, pediatric, relapse, EDSS, ofatumumab, siponimod, fingolimod, RMS, MS

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

ofatumumab - 20 mg injection/ placebo

siponimod - 0.5 mg, 1 mg or 2 mg/ placebo

fingolimod - 0.5 mg or 0.25 mg/ placebo

Arm Description

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).

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).

Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).

Outcomes

Primary Outcome Measures

Annualized relapse rate (ARR) in target pediatric participants
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
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
Number of new/newly enlarged T2 lesions per year
Neurofilament light chain (NfL) concentrations
Neurofilament light chain (NfL) concentration in serum of ofatumumab and/or siponimod versus fingolimod
Plasma Concentrations of ofatumumab
Ofatumumab plasma concentrations
Plasma Concentrations of siponimod
Siponimod plasma concentrations
Plasma Concentrations of siponimod metabolite (M17)
Siponimod metabolite (M17) plasma concentration
Percentage of participants with anti-ofatumumab antibodies
Anti-ofatumumab antibodies to demonstrate immunogenicity of ofatumumab
Number of adverse events and serious adverse events
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

Full Information

First Posted
June 14, 2021
Last Updated
October 9, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04926818
Brief Title
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
Acronym
NEOS
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
August 4, 2026 (Anticipated)
Study Completion Date
June 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis (MS)
Keywords
relapsing multiple sclerosis, pediatric, relapse, EDSS, ofatumumab, siponimod, fingolimod, RMS, MS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ofatumumab - 20 mg injection/ placebo
Arm Type
Experimental
Arm Description
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).
Arm Title
siponimod - 0.5 mg, 1 mg or 2 mg/ placebo
Arm Type
Experimental
Arm Description
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).
Arm Title
fingolimod - 0.5 mg or 0.25 mg/ placebo
Arm Type
Active Comparator
Arm Description
Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).
Intervention Type
Drug
Intervention Name(s)
Fingolimod
Other Intervention Name(s)
FTY720
Intervention Description
Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight).
Intervention Type
Drug
Intervention Name(s)
Ofatumumab
Other Intervention Name(s)
OMB157
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Siponimod
Other Intervention Name(s)
BAF312
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Fingolimod placebo
Intervention Description
Fingolimod matching placebo capsule
Intervention Type
Other
Intervention Name(s)
Siponimod placebo
Intervention Description
Siponimod matching placebo tablet
Intervention Type
Other
Intervention Name(s)
Ofatumumab placebo
Intervention Description
Ofatumumab matching placebo autoinjector
Primary Outcome Measure Information:
Title
Annualized relapse rate (ARR) in target pediatric participants
Description
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).
Time Frame
Baseline up to 24 months
Secondary Outcome Measure Information:
Title
Annualized relapse rate (ARR) as compared to historical interferon β-1a data
Description
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.
Time Frame
Baseline up to 24 months
Title
Annualized T2 lesion rate
Description
Number of new/newly enlarged T2 lesions per year
Time Frame
Baseline up to 24 months
Title
Neurofilament light chain (NfL) concentrations
Description
Neurofilament light chain (NfL) concentration in serum of ofatumumab and/or siponimod versus fingolimod
Time Frame
Day 1, Months 3,6,12,18,24
Title
Plasma Concentrations of ofatumumab
Description
Ofatumumab plasma concentrations
Time Frame
Day 1, pre-dose for Day 7, Months 2,3,5,6,12,18,24
Title
Plasma Concentrations of siponimod
Description
Siponimod plasma concentrations
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
Title
Plasma Concentrations of siponimod metabolite (M17)
Description
Siponimod metabolite (M17) plasma concentration
Time Frame
Pre-dose Month 3, 5 and Month 12
Title
Percentage of participants with anti-ofatumumab antibodies
Description
Anti-ofatumumab antibodies to demonstrate immunogenicity of ofatumumab
Time Frame
Day 1, Pre-Dose Months 2,3,5,6,12,18,24
Title
Number of adverse events and serious adverse events
Description
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
Time Frame
Baseline up approximately 66 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104 4399
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Esneux
ZIP/Postal Code
4130
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lo Barnechea
State/Province
Santiago
ZIP/Postal Code
7691236
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 060
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226014
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700017
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Petach-Tikva
ZIP/Postal Code
49202
Country
Israel
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80 952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Warsaw
ZIP/Postal Code
04 730
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Coimbra
ZIP/Postal Code
3000-602
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
190000
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Baracaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Istanbul
State/Province
TUR
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

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