Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Un estudio para investigar la eficacia, seguridad y tolerabilidad de remibrutinib frente a placebo en pacientes adultos con miastenia gravis generalizada (RELIEVE)

25 de septiembre de 2026 actualizado por: Novartis Pharmaceuticals

Un estudio de fase III aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de remibrutinib en pacientes con miastenia gravis generalizada, seguido de una fase de extensión abierta

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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

180

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Remibrutinib arm

Core Part: Remibrutinib tablet taken orally

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

Remibrutinib (Blinded) active treatment

Otros nombres:
  • Lou64
Droga: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Otros nombres:
  • LOU064
Comparador de placebos: Placebo arm

Core Part: Placebo tablet taken orally

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

Placebo

Droga: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Otros nombres:
  • LOU064

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline to Month 6 in Quantitative Myasthenia Gravis (QMG) total score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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）
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de febrero de 2025

Finalización primaria (Estimado)

25 de febrero de 2028

Finalización del estudio (Estimado)

26 de febrero de 2033

Fechas de registro del estudio

Enviado por primera vez

17 de diciembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

17 de diciembre de 2024

Publicado por primera vez (Actual)

20 de diciembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CLOU064O12301
  • 2023-510026-32 (Otro identificador: EU CTIS)
  • 2023 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir