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Studie zkoumající účinnost, bezpečnost a snášenlivost přípravku Remibrutinib versus placebo u dospělých pacientů s generalizovanou myasthenia gravis (RELIEVE)

25. září 2026 aktualizováno: Novartis Pharmaceuticals

Randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze III k hodnocení účinnosti, bezpečnosti a snášenlivosti remibrutinibu u pacientů s generalizovanou myasthenia gravis, po níž následovala otevřená fáze prodloužení

A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

This study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate the efficacy, safety and tolerability of remibrutinib in gMG patients who are on stable SOC treatment. Approximately 180 eligible participants will be randomized in a ratio of 1:1, to receive either remibrutinib or matching placebo.

The study consists of a Core Part (6-months double-blind treatment) and an Extension Part (up to 60-month open-label treatment).

Typ studie

Intervenční

Zápis (Odhadovaný)

180

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Argentina
      • Buenos Aires, Argentina, C1012AAR
        • Novartis Investigative Site
      • Caba, Argentina, C1055AAF
        • Novartis Investigative Site
      • Capital Federal, Argentina, C1023AAB
        • Novartis Investigative Site
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Novartis Investigative Site
  • Austrálie
    • Victoria
      • Fitzroy, Victoria, Austrálie, 3065
        • Novartis Investigative Site
  • Brazílie
      • São Paulo, Brazílie, 05403-000
        • Novartis Investigative Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazílie, 40050-410
        • Novartis Investigative Site
    • Federal District
      • Brasília, Federal District, Brazílie, 70200-730
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brazílie, 95070-560
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brazílie, 90480-110
        • Novartis Investigative Site
  • Francie
      • Bordeaux, Francie, 33076
        • Novartis Investigative Site
      • Nice, Francie, 06000
        • Novartis Investigative Site
      • Paris, Francie, 75013
        • Novartis Investigative Site
      • Paris, Francie, 75940
        • Novartis Investigative Site
      • Strasbourg, Francie, 67081
        • Novartis Investigative Site
      • Toulouse, Francie, 31059
        • Novartis Investigative Site
  • Gruzie
      • Kutaisi, Gruzie, 4600
        • Novartis Investigative Site
      • Tbilisi, Gruzie, 0114
        • Novartis Investigative Site
      • Tbilisi, Gruzie, 0144
        • Novartis Investigative Site
  • Holandsko
    • North Holland
      • Amsterdam, North Holland, Holandsko, 1105 AZ
        • Novartis Investigative Site
  • Indie
    • Haryana
      • Gurugram, Haryana, Indie, 122011
        • Novartis Investigative Site
    • Karnataka
      • Mangalore, Karnataka, Indie, 575002
        • Novartis Investigative Site
    • Maharashtra
      • Nashik, Maharashtra, Indie, 422005
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, Indie, 110029
        • Novartis Investigative Site
    • Punjab
      • Ludhiana, Punjab, Indie, 141001
        • Novartis Investigative Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, Indie, 632004
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, Indie, 500082
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, Indie, 226007
        • Novartis Investigative Site
  • Itálie
    • BG
      • Bergamo, BG, Itálie, 24127
        • Novartis Investigative Site
    • TO
      • Orbassano, TO, Itálie, 10043
        • Novartis Investigative Site
  • Japonsko
      • Chiba, Japonsko, 2608677
        • Novartis Investigative Site
      • Fukuoka, Japonsko, 8128582
        • Novartis Investigative Site
      • Fukushima, Japonsko, 9601295
        • Novartis Investigative Site
      • Hiroshima, Japonsko, 7348551
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japonsko, 0630005
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japonsko, 0608543
        • Novartis Investigative Site
    • Hyōgo
      • Nishinomiya, Hyōgo, Japonsko, 6638501
        • Novartis Investigative Site
    • Iwate
      • Hanamaki, Iwate, Japonsko, 0250082
        • Novartis Investigative Site
    • Miyagi
      • Sendai, Miyagi, Japonsko, 9838520
        • Novartis Investigative Site
    • Osaka
      • Suita, Osaka, Japonsko, 5650871
        • Novartis Investigative Site
    • Saitama
      • Higashi-Matsuyama, Saitama, Japonsko, 3550005
        • Novartis Investigative Site
      • Koshigaya, Saitama, Japonsko, 3438555
        • Novartis Investigative Site
    • Tokyo
      • Shinjuku Ku, Tokyo, Japonsko, 1600023
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japonsko, 1608582
        • Novartis Investigative Site
  • Jižní Korea
      • Busan, Jižní Korea, 49241
        • Novartis Investigative Site
      • Seoul, Jižní Korea, 03080
        • Novartis Investigative Site
      • Seoul, Jižní Korea, 03722
        • Novartis Investigative Site
      • Seoul, Jižní Korea, 05278
        • Novartis Investigative Site
  • Kanada
    • Ontario
      • London, Ontario, Kanada, N6A 5W9
        • Novartis Investigative Site
      • Ottawa, Ontario, Kanada, K1H 8L6
        • Novartis Investigative Site
    • Quebec
      • Québec, Quebec, Kanada, G1J 1Z4
        • Novartis Investigative Site
  • Německo
      • Gummersbach, Německo, 51643
        • Novartis Investigative Site
      • Hamburg, Německo, 20246
        • Novartis Investigative Site
      • Münster, Německo, 48149
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Německo, 60590
        • Novartis Investigative Site
  • Polsko
      • Bydgoszcz, Polsko, 85-065
        • Novartis Investigative Site
      • Katowice, Polsko, 40-689
        • Novartis Investigative Site
      • Lodz, Polsko, 93-113
        • Novartis Investigative Site
      • Lublin, Polsko, 20-701
        • Novartis Investigative Site
      • Lublin, Polsko, 20-410
        • Novartis Investigative Site
      • Poznan, Polsko, 61-731
        • Novartis Investigative Site
      • Skorzewo, Polsko, 60-185
        • Novartis Investigative Site
      • Warsaw, Polsko, 01-684
        • Novartis Investigative Site
      • Warsaw, Polsko, 02-172
        • Novartis Investigative Site
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polsko, 20-064
        • Novartis Investigative Site
      • Lublin, Lublin Voivodeship, Polsko, 20-080
        • Novartis Investigative Site
    • POL
      • Krakow, POL, Polsko, 31-505
        • Novartis Investigative Site
  • Rumunsko
      • Brasov, Rumunsko, 500283
        • Novartis Investigative Site
      • Bucharest, Rumunsko, 040215
        • Novartis Investigative Site
      • Sibiu, Rumunsko, 550245
        • Novartis Investigative Site
  • Spojené království
      • London, Spojené království, SW17 0QT
        • Novartis Investigative Site
  • Spojené státy
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85013
        • Neuromuscular Research Center
      • Scottsdale, Arizona, Spojené státy, 85258
        • Honor Health Research Institute
    • California
      • Fullerton, California, Spojené státy, 92835
        • Fullerton Neuro and Headache Ctr
      • Los Angeles, California, Spojené státy, 90033
        • University Of Southern California
      • Sacramento, California, Spojené státy, 94115
        • California Pacific Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, Spojené státy, 20010-2975
        • Medstar Washington Hospital Center
    • Florida
      • Boca Raton, Florida, Spojené státy, 33487
        • SFM Clinical Research LLC
      • Homestead, Florida, Spojené státy, 33033
        • Homestead Assoc In Research Inc
      • Maitland, Florida, Spojené státy, 32751
        • Neurology Associates PA
      • Orlando, Florida, Spojené státy, 32804
        • AdventHealth
      • Orlando, Florida, Spojené státy, 32806
        • Neurological Services of Orlando PA
    • Illinois
      • Chicago, Illinois, Spojené státy, 60637
        • University of Chicago Medical Centr
    • Maryland
      • Bethesda, Maryland, Spojené státy, 20817-1807
        • Mid Atlantic Epilepsy and Sleep Ctr
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02114
        • Massachusetts General Hospital
    • Michigan
      • East Lansing, Michigan, Spojené státy, 48824
        • Michigan State University-Department of Neurology
    • New York
      • Buffalo, New York, Spojené státy, 14209
        • Dent Neurological Institute
    • Ohio
      • Cleveland, Ohio, Spojené státy, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Spojené státy, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, Spojené státy, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Spojené státy, 77030
        • UT Health Science Center
      • San Antonio, Texas, Spojené státy, 78229-3900
        • University of Texas Health Science Center at San Antonio
    • Washington
      • Seattle, Washington, Spojené státy, 98195
        • University of WA Division of Cardio
    • Wisconsin
      • Greenfield, Wisconsin, Spojené státy, 53228-1321
        • Center for Neurological Disorders G
  • Srbsko
      • Belgrade, Srbsko, 11000
        • Novartis Investigative Site
      • Niš, Srbsko, 18108
        • Novartis Investigative Site
      • Novi Sad, Srbsko, 21000
        • Novartis Investigative Site
  • Tchaj-wan
      • Kaohsiung City, Tchaj-wan, 833
        • Novartis Investigative Site
      • Tainan, Tchaj-wan, 704302
        • Novartis Investigative Site
      • Taipei, Tchaj-wan, 10002
        • Novartis Investigative Site
      • Taipei, Tchaj-wan, 111045
        • Novartis Investigative Site
      • Taoyuan, Tchaj-wan, 33305
        • Novartis Investigative Site
  • Čína
      • Beijing, Čína, 100730
        • Novartis Investigative Site
      • Beijing, Čína, 100034
        • Novartis Investigative Site
      • Qingdao, Čína, 266000
        • Novartis Investigative Site
      • Shanghai, Čína, 200080
        • Novartis Investigative Site
      • Shanghai, Čína, 200040
        • Novartis Investigative Site
    • Anhui
      • Hefei, Anhui, Čína, 230001
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Čína, 510080
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, Čína, 050030
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, Čína, 450003
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, Čína, 430030
        • Novartis Investigative Site
    • Jiangsu
      • Wuxi, Jiangsu, Čína, 214023
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, Čína, 130021
        • Novartis Investigative Site
  • Španělsko
      • Barcelona, Španělsko, 08035
        • Novartis Investigative Site
      • Lleida, Španělsko, 25198
        • Novartis Investigative Site
      • Madrid, Španělsko, 28034
        • Novartis Investigative Site
      • Málaga, Španělsko, 29010
        • Novartis Investigative Site
      • Valencia, Španělsko, 46026
        • Novartis Investigative Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Adult patients with gMG (age 18-85 years)
  • Confirmed diagnosis of Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening and likely not in need of a respirator for the duration of the study, as judged by the Investigator
  • Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative for both AChR and MuSK antibodies at screening
  • Baseline MG-ADL score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms
  • Participants who have been receiving a standard-of-care treatment as specified in the protocol
  • Able to safely swallow the study medication according to investigator clinical judgement based on a bedside swallowing test or another formal swallowing test in line with local practice, both at Screening and Baseline

Exclusion Criteria:

  • Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-FcRn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period
  • Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment

Other protocol-defined inclusion/exclusion criteria may apply.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Remibrutinib arm

Core Part: Remibrutinib tablet taken orally

[Extension Part: Open-label remibrutinib tablet taken orally]
Lék: Remibrutinib (Blinded)

Remibrutinib (Blinded) active treatment

Ostatní jména:
  • LOU64
Lék: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Ostatní jména:
  • LOU064
Komparátor placeba: Placebo arm

Core Part: Placebo tablet taken orally

[Extension Part: Open-label remibrutinib tablet taken orally]
Jiný: Placebo

Placebo

Lék: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Ostatní jména:
  • LOU064

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
Časové okno: Baseline to Month 6

The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG.

Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24).
Baseline to Month 6

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline to Month 6 in Quantitative Myasthenia Gravis (QMG) total score
Časové okno: Baseline to Month 6

The Quantitative Myasthenia Gravis (QMG) Score is a 13-item direct physician assessment scoring system that quantifies disease severity, based on impairments of body functions and structures. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity. The QMG score is composed of the following items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item) and respiratory (1 item).
Baseline to Month 6
Proportion of participants with ≥ 5 points reduction from baseline to Month 6 of QMG total score without rescue medication and/or strongly confounding prohibited medication
Časové okno: Baseline to Month 6

The Quantitative Myasthenia Gravis (QMG) Score is a 13-item direct physician assessment scoring system that quantifies disease severity, based on impairments of body functions and structures. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity. The QMG score is composed of the following items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item) and respiratory (1 item).
Baseline to Month 6
Proportion of participants with ≥ 3 points reduction from baseline to Month 6 of Myasthenia Gravis Activity of Daily Living (MG-ADL) scale total score without rescue medication and/or strongly confounding prohibited medication
Časové okno: Baseline to Month 6

The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG.

Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24).
Baseline to Month 6
Proportion of participants achieving Minimal Symptom Expression (MSE) at Month 6, defined as MG-ADL score of 0 or 1 at Month 6 without rescue therapy and/or strongly confounding prohibited medication
Časové okno: Month 6

The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG.

Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24).
Month 6
Change from baseline to Month 6 in Myasthenia Gravis Composite score (MGC) total score
Časové okno: Baseline to Month 6

The MGC is a 10-item instrument that measures the symptoms and signs of MG based on physician examination and patient history. Items relate to ptosis, double vision, eye closure, talking, chewing, swallowing, breathing, neck flexion, shoulder abduction, and hip flexion. Each item is scored on an ordinal scale with 4 possible categories and weighted. The total score ranges from 0 to 50, where higher scores indicating more severe impairments.
Baseline to Month 6
Change from baseline to Month 6 in revised Myasthenia Gravis Quality of Life Questionnaire (MG-QOL15r) survey score
Časové okno: Baseline to Month 6

The revised MG-QoL15 is a 15-item health related quality of life questionnaire completed by participants, designed to measure quality of life in gMG. Items on the MG-QoL15 relate to physical, social, and psychological components and are scored from 0 (not at all) to 2 (very much). The cumulative scores range from 0 to 30, with higher scores representing worse quality of life and dissatisfaction with MG-related dysfunction.
Baseline to Month 6
Incidence of adverse events
Časové okno: Baseline to Month 6

Incidence of adverse events including changes in clinical laboratory values, vital signs, electrocardiograms and suicidality results qualifying and reported as AEs.
Baseline to Month 6
Proportion of time during which participants showed a reduction of ≥ 2 points in MG-ADL total score, that was maintained up to Month 6
Časové okno: Baseline to Month 6

The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24).
Baseline to Month 6
Proportion of early MG-ADL responders during treatment (early responders with first MG-ADL improvement from baseline of ≥ 2 points occurring by week 4）
Časové okno: Baseline to week 4

The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24). Participants with a first MG-ADL improvement from baseline of ≥ 2 points occurring by week 4 are considered early responders.
Baseline to week 4
Change from baseline to Month 6 in EuroQol-5 Dimensions-5 Level (EQ-5D-5L)
Časové okno: Baseline to Month 6

The EQ-5D-5L is a widely used questionnaire designed to assess health status in adults. The measure is divided into two distinct sections, the descriptive system and the EQ visual analogue scale (EQ VAS). The first section includes one item addressing each of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Participants rate each of these items from 1 of the 5 levels: no problems, slight problems, moderate problems, severe problems, or unable to/extreme. A composite health state is then defined by combining the levels for each dimension into a 5-digit number. The second section includes the EQ visual analogue scale (EQ VAS) that measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the "best imaginable health state" and 0 represents the "worst imaginable health state." Respondents are asked to rate their current health by placing a mark along this continuum.
Baseline to Month 6
Proportion of participants achieving a reduction from baseline of ≥ 3 points in MGC total score at Month 6
Časové okno: Baseline to Month 6

The MGC is a 10-item instrument that measures the symptoms and signs of MG based on physician examination and patient history. Items relate to ptosis, double vision, eye closure, talking, chewing, swallowing, breathing, neck flexion, shoulder abduction, and hip flexion. Each item is scored on an ordinal scale with 4 possible categories and weighted. The total score ranges from 0 to 50, where higher scores indicating more severe impairments.
Baseline to Month 6
Change from baseline in MG-ADL total score
Časové okno: Baseline to Month 66

The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24).
Baseline to Month 66
Change from baseline in QMG total score
Časové okno: Baseline to Month 66

The Quantitative Myasthenia Gravis (QMG) Score is a 13-item direct physician assessment scoring system that quantifies disease severity, based on impairments of body functions and structures. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity. The QMG score is composed of the following items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item) and respiratory (1 item).
Baseline to Month 66
Change from baseline in MGC total score
Časové okno: Baseline to Month 66

The MGC is a 10-item instrument that measures the symptoms and signs of MG based on physician examination and patient history. Items relate to ptosis, double vision, eye closure, talking, chewing, swallowing, breathing, neck flexion, shoulder abduction, and hip flexion. Each item is scored on an ordinal scale with 4 possible categories and weighted. The total score ranges from 0 to 50, where higher scores indicating more severe impairments.
Baseline to Month 66
Proportion of participants achieving a reduction from core part in oral corticosteroids (OCS) dose till the end of extension part
Časové okno: Baseline to month 66

Participants receiving oral corticosteroids are required to be on a stable dose for at least 4 weeks prior to baseline. The dose can be reduced or discontinued during the open label extension period at investigator discretion. Oral corticosteroids use will be recorded.
Baseline to month 66
Incidence of adverse events
Časové okno: Month 7 to month 66

Incidence of adverse events including changes in clinical laboratory values, vital signs, electrocardiograms and suicidality results qualifying and reported as AEs.
Month 7 to month 66

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novartis Pharmaceuticals

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

7. února 2025

Primární dokončení (Odhadovaný)

25. února 2028

Dokončení studie (Odhadovaný)

26. února 2033

Termíny zápisu do studia

První předloženo

17. prosince 2024

První předloženo, které splnilo kritéria kontroly kvality

17. prosince 2024

První zveřejněno (Aktuální)

20. prosince 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CLOU064O12301
  • 2023-510026-32 (Jiný identifikátor: EU CTIS)
  • 2023 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.com.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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