ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT04926818 (NEOS) के लिए मल्टीपल स्क्लेरोसिस (एमएस) वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
नोवार्टिसEfficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (NEOS)
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT04926818 (NEOS) का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन मल्टीपल स्क्लेरोसिस (एमएस) से जुड़ा हुआ है और यह एक चरण III हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 5 अक्तूबर 2021 को हुई थी, और इसमें कुल 129 प्रतिभागियों के नामांकन की योजना है। नोवार्टिस इस परीक्षण का नेतृत्व कर रहे हैं और इसके 19 नवंबर 2031 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 30 सितंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
विस्तृत विवरण
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.
आधिकारिक शीर्षक
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
चिकित्सीय स्थितियाँ
मल्टीपल स्क्लेरोसिस (एमएस)अन्य अध्ययन आईडी
- NEOS
- CBAF312D2301
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2021-10-05
अंतिम अद्यतन प्रकाशित
2025-09-30
अध्ययन की समाप्ति तिथि (अनुमानित)
2031-11-19
नामांकन (अनुमानित)
129
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण III
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
relapsing multiple sclerosis
pediatric
relapse
EDSS
ofatumumab
siponimod
fingolimod
RMS
MS
pediatric
relapse
EDSS
ofatumumab
siponimod
fingolimod
RMS
MS
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
चौहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
प्रयोगात्मकofatumumab - 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). | ओफातुमुमैब 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 |
प्रयोगात्मकsiponimod - 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). | सिपोनिमोड 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 |
सक्रिय तुलना समूहfingolimod - 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 |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा
अध्ययन के लिए न्यूनतम आयु
10 Years
अध्ययन के लिए पात्र लिंग
सभी
- 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
कोई संपर्क डेटा नहीं।
51 25 देशों में अध्ययन स्थल
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
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
Novartis Investigative Site, Esneux, 4130, Belgium
Novartis Investigative Site, Ghent, 9000, Belgium
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
Quebec
Novartis Investigative Site, Montreal, Quebec, H3A 2B4, Canada
Novartis Investigative Site, Montreal, Quebec, H3T 1C5, Canada
Santiago Metropolitan
Novartis Investigative Site, Lo Barnechea, Santiago Metropolitan, 7691236, Chile
Novartis Investigative Site, Zagreb, 10000, Croatia
Novartis Investigative Site, Tallinn, 11315, Estonia
Novartis Investigative Site, Le Kremlin-Bicêtre, 94275, France
Novartis Investigative Site, Montpellier, 34090, France
Novartis Investigative Site, Strasbourg, 67000, France
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
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)