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Een onderzoek om de werkzaamheid, veiligheid en verdraagbaarheid van remibrutinib versus placebo te onderzoeken bij volwassen patiënten met gegeneraliseerde myasthenia gravis (RELIEVE)

25 september 2026 bijgewerkt door: Novartis Pharmaceuticals

Een gerandomiseerde, dubbelblinde, placebogecontroleerde fase III-studie om de werkzaamheid, veiligheid en verdraagbaarheid van remibrutinib te evalueren bij patiënten met gegeneraliseerde myasthenia gravis, gevolgd door een open-label verlengingsfase

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

180

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Remibrutinib arm

Core Part: Remibrutinib tablet taken orally

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

Remibrutinib (Blinded) active treatment

Andere namen:
  • LOU64
Geneesmiddel: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Andere namen:
  • LOU064
Placebo-vergelijker: Placebo arm

Core Part: Placebo tablet taken orally

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

Placebo

Geneesmiddel: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Andere namen:
  • LOU064

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline to Month 6 in Quantitative Myasthenia Gravis (QMG) total score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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）
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 februari 2025

Primaire voltooiing (Geschat)

25 februari 2028

Studie voltooiing (Geschat)

26 februari 2033

Studieregistratiedata

Eerst ingediend

17 december 2024

Eerst ingediend dat voldeed aan de QC-criteria

17 december 2024

Eerst geplaatst (Werkelijk)

20 december 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

25 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLOU064O12301
  • 2023-510026-32 (Andere identificatie: EU CTIS)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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