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L'essai clinique NCT04926818 (NEOS) pour Sclérose en plaques (SEP) est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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NovartisEfficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (NEOS)
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L'essai clinique NCT04926818 (NEOS) est conçu pour étudier le treatment de Sclérose en plaques (SEP). Il s'agit d'un essai interventionnel en Phase III. Son statut actuel est : actif, pas en recrutement. L'essai a débuté le 5 octobre 2021 et vise à recruter 129 participants. Dirigé par Novartis, l'essai devrait être terminé d'ici le 19 novembre 2031. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 30 septembre 2025.
Résumé succinct
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
Description détaillée
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 120 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.
Titre officiel
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
Conditions
Sclérose en plaques (SEP)Autres identifiants de l'essai
- NEOS
- CBAF312D2301
Numéro NCT
Date de début (réel)
2021-10-05
Dernière mise à jour publiée
2025-09-30
Date de fin (estimée)
2031-11-19
Inscription (estimée)
129
Type d'essai
Interventionnel
PHASE
Phase III
Statut
Actif, pas en recrutement
Mots clés
relapsing multiple sclerosis
pediatric
relapse
EDSS
ofatumumab
siponimod
fingolimod
RMS
MS
pediatric
relapse
EDSS
ofatumumab
siponimod
fingolimod
RMS
MS
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Expérimentalofatumumab - 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). | 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). Ofatumumab Placebo Ofatumumab matching placebo autoinjector |
Expérimentalsiponimod - 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). | 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). Siponimod Placebo Siponimod matching placebo tablet |
Comparateur actiffingolimod - 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). | 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). Fingolimod Placebo Fingolimod matching placebo capsule |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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). | Baseline up to 24 months |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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. | Baseline up to 24 months |
Annualized T2 lesion rate | Number of new/newly enlarged T2 lesions per year | Baseline up to 24 months |
Neurofilament light chain (NfL) concentrations | Neurofilament light chain (NfL) concentration in serum of ofatumumab and/or siponimod versus fingolimod | Day 1, Months 3,6,12,18,24 |
Plasma Concentrations of ofatumumab | Ofatumumab plasma concentrations | Day 1, pre-dose for Day 7, Months 2,3,5,6,12,18,24 |
Plasma Concentrations of siponimod | Siponimod plasma concentrations | Day 1 (2,3,4,6 h), Day 3 (2,3,4,6 h), pre-dose for Months 1 (pre, 3h), 3,5,12 |
Plasma Concentrations of siponimod metabolite (M17) | Siponimod metabolite (M17) plasma concentration | Pre-dose Month 3, 5 and Month 12 |
Percentage of participants with anti-ofatumumab antibodies | Anti-ofatumumab antibodies to demonstrate immunogenicity of ofatumumab | Day 1, Pre-Dose Months 2,3,5,6,12,18,24 |
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 | Baseline up approximately 66 months |
Critères d'éligibilité
Âges éligibles
Enfant
Âge minimum
10 Years
Sexes éligibles
Tous
- 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
- 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
Aucune donnée de contact disponible
51 Centres de l'essai dans 25 pays
Novartis Investigative Site, Le Kremlin-Bicêtre, 94275, France
Novartis Investigative Site, Montpellier, 34090, France
Novartis Investigative Site, Strasbourg, 67000, France
Novartis Investigative Site, Esneux, 4130, Belgium
Novartis Investigative Site, Ghent, 9000, Belgium
Quebec
Novartis Investigative Site, Montreal, Quebec, H3A 2B4, Canada
Novartis Investigative Site, Montreal, Quebec, H3T 1C5, Canada
Arkansas
Arkansas Childrens Hosp Rsch Inst, Little Rock, Arkansas, 72202, United States
California
Childrens Hospital Los Angeles, Los Angeles, California, 90027, United States
District of Columbia
Childrens National Medical Center, Washington D.C., District of Columbia, 20010, United States
Florida
Axiom Clinical Research of Florida, Tampa, Florida, 33609, United States
Pennsylvania
Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104 4399, United States
Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Buenos Aires
Novartis Investigative Site, CABA, Buenos Aires, C1181ACH, Argentina
Victoria
Novartis Investigative Site, Parkville, Victoria, 3052, Australia
Novartis Investigative Site, Vienna, 1090, Austria
Paraná
Novartis Investigative Site, Curitiba, Paraná, 81210-310, Brazil
Rio Grande do Sul
Novartis Investigative Site, Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
São Paulo
Novartis Investigative Site, São Paulo, São Paulo, 05403-000, Brazil
Santiago Metropolitan
Novartis Investigative Site, Lo Barnechea, Santiago Metropolitan, 7691236, Chile
Novartis Investigative Site, Zagreb, 10000, Croatia
Novartis Investigative Site, Tallinn, 11315, Estonia
Baden-Wurttemberg
Novartis Investigative Site, Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Lower Saxony
Novartis Investigative Site, Göttingen, Lower Saxony, 37075, Germany
Novartis Investigative Site, Bochum, 44791, Germany
Novartis Investigative Site, Guatemala City, 01015, Guatemala
National Capital Territory of Delhi
Novartis Investigative Site, New Delhi, National Capital Territory of Delhi, 110 017, India
Uttar Pradesh
Novartis Investigative Site, Lucknow, Uttar Pradesh, 226014, India
West Bengal
Novartis Investigative Site, Kolkata, West Bengal, 700017, India
Novartis Investigative Site, Petah Tikva, 4920235, Israel
RM
Novartis Investigative Site, Roma, RM, 00165, Italy
Novartis Investigative Site, Napoli, 80131, Italy
Novartis Investigative Site, Riga, LV-1004, Latvia
Mexico City
Novartis Investigative Site, Mexico City, Mexico City, 06700, Mexico
Novartis Investigative Site, Mexico City, Mexico City, 06720, Mexico
Novartis Investigative Site, Gdansk, 80-952, Poland
Novartis Investigative Site, Lodz, 93-338, Poland
Novartis Investigative Site, Poznan, 60-355, Poland
Novartis Investigative Site, Warsaw, 04-730, Poland
Novartis Investigative Site, Coimbra, 3000-602, Portugal
Novartis Investigative Site, Lisbon, 1169-050, Portugal
Novartis Investigative Site, Belgrade, 11000, Serbia
Novartis Investigative Site, Bratislava, 833 40, Slovakia
Andalusia
Novartis Investigative Site, Seville, Andalusia, 41009, Spain
Vizcaya
Novartis Investigative Site, Barakaldo, Vizcaya, 48903, Spain
Novartis Investigative Site, Tainan, 70403, Taiwan
Novartis Investigative Site, Taipei, 10002, Taiwan
Atakum
Novartis Investigative Site, Samsun, Atakum, 55200, Turkey (Türkiye)
Fatih
Novartis Investigative Site, Istanbul, Fatih, 34098, Turkey (Türkiye)
Izmit
Novartis Investigative Site, Kocaeli, Izmit, 41380, Turkey (Türkiye)
Karsiyaka
Novartis Investigative Site, Izmir, Karsiyaka, 35575, Turkey (Türkiye)