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En undersøgelse til at undersøge effektiviteten, sikkerheden og tolerabiliteten af ​​remibrutinib versus placebo hos voksne patienter med generaliseret myasthenia gravis (RELIEVE)

25. september 2026 opdateret af: Novartis Pharmaceuticals

Et randomiseret, dobbeltblindt, placebokontrolleret fase III-studie til evaluering af effektivitet, sikkerhed og tolerabilitet af remibrutinib hos patienter med generaliseret myasthenia gravis, efterfulgt af en åben forlængelsesfase

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Australien
    • Victoria
      • Fitzroy, Victoria, Australien, 3065
        • Novartis Investigative Site
  • Brasilien
      • São Paulo, Brasilien, 05403-000
        • Novartis Investigative Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasilien, 40050-410
        • Novartis Investigative Site
    • Federal District
      • Brasília, Federal District, Brasilien, 70200-730
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brasilien, 95070-560
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brasilien, 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
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, SW17 0QT
        • Novartis Investigative Site
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Neuromuscular Research Center
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Honor Health Research Institute
    • California
      • Fullerton, California, Forenede Stater, 92835
        • Fullerton Neuro and Headache Ctr
      • Los Angeles, California, Forenede Stater, 90033
        • University Of Southern California
      • Sacramento, California, Forenede Stater, 94115
        • California Pacific Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010-2975
        • Medstar Washington Hospital Center
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33487
        • SFM Clinical Research LLC
      • Homestead, Florida, Forenede Stater, 33033
        • Homestead Assoc In Research Inc
      • Maitland, Florida, Forenede Stater, 32751
        • Neurology Associates PA
      • Orlando, Florida, Forenede Stater, 32804
        • AdventHealth
      • Orlando, Florida, Forenede Stater, 32806
        • Neurological Services of Orlando PA
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Medical Centr
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20817-1807
        • Mid Atlantic Epilepsy and Sleep Ctr
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Michigan
      • East Lansing, Michigan, Forenede Stater, 48824
        • Michigan State University-Department of Neurology
    • New York
      • Buffalo, New York, Forenede Stater, 14209
        • Dent Neurological Institute
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Forenede Stater, 77030
        • UT Health Science Center
      • San Antonio, Texas, Forenede Stater, 78229-3900
        • University of Texas Health Science Center at San Antonio
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of WA Division of Cardio
    • Wisconsin
      • Greenfield, Wisconsin, Forenede Stater, 53228-1321
        • Center for Neurological Disorders G
  • Frankrig
      • Bordeaux, Frankrig, 33076
        • Novartis Investigative Site
      • Nice, Frankrig, 06000
        • Novartis Investigative Site
      • Paris, Frankrig, 75013
        • Novartis Investigative Site
      • Paris, Frankrig, 75940
        • Novartis Investigative Site
      • Strasbourg, Frankrig, 67081
        • Novartis Investigative Site
      • Toulouse, Frankrig, 31059
        • Novartis Investigative Site
  • Georgien
      • Kutaisi, Georgien, 4600
        • Novartis Investigative Site
      • Tbilisi, Georgien, 0114
        • Novartis Investigative Site
      • Tbilisi, Georgien, 0144
        • Novartis Investigative Site
  • Holland
    • North Holland
      • Amsterdam, North Holland, Holland, 1105 AZ
        • Novartis Investigative Site
  • Indien
    • Haryana
      • Gurugram, Haryana, Indien, 122011
        • Novartis Investigative Site
    • Karnataka
      • Mangalore, Karnataka, Indien, 575002
        • Novartis Investigative Site
    • Maharashtra
      • Nashik, Maharashtra, Indien, 422005
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, Indien, 110029
        • Novartis Investigative Site
    • Punjab
      • Ludhiana, Punjab, Indien, 141001
        • Novartis Investigative Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, Indien, 632004
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, Indien, 500082
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, Indien, 226007
        • Novartis Investigative Site
  • Italien
    • BG
      • Bergamo, BG, Italien, 24127
        • Novartis Investigative Site
    • TO
      • Orbassano, TO, Italien, 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
  • Kina
      • Beijing, Kina, 100730
        • Novartis Investigative Site
      • Beijing, Kina, 100034
        • Novartis Investigative Site
      • Qingdao, Kina, 266000
        • Novartis Investigative Site
      • Shanghai, Kina, 200080
        • Novartis Investigative Site
      • Shanghai, Kina, 200040
        • Novartis Investigative Site
    • Anhui
      • Hefei, Anhui, Kina, 230001
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050030
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, Kina, 450003
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Novartis Investigative Site
    • Jiangsu
      • Wuxi, Jiangsu, Kina, 214023
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • 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
  • Rumænien
      • Brasov, Rumænien, 500283
        • Novartis Investigative Site
      • Bucharest, Rumænien, 040215
        • Novartis Investigative Site
      • Sibiu, Rumænien, 550245
        • Novartis Investigative Site
  • Serbien
      • Belgrade, Serbien, 11000
        • Novartis Investigative Site
      • Niš, Serbien, 18108
        • Novartis Investigative Site
      • Novi Sad, Serbien, 21000
        • Novartis Investigative Site
  • Spanien
      • Barcelona, Spanien, 08035
        • Novartis Investigative Site
      • Lleida, Spanien, 25198
        • Novartis Investigative Site
      • Madrid, Spanien, 28034
        • Novartis Investigative Site
      • Málaga, Spanien, 29010
        • Novartis Investigative Site
      • Valencia, Spanien, 46026
        • Novartis Investigative Site
  • Sydkorea
      • Busan, Sydkorea, 49241
        • Novartis Investigative Site
      • Seoul, Sydkorea, 03080
        • Novartis Investigative Site
      • Seoul, Sydkorea, 03722
        • Novartis Investigative Site
      • Seoul, Sydkorea, 05278
        • 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
  • Tyskland
      • Gummersbach, Tyskland, 51643
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20246
        • Novartis Investigative Site
      • Münster, Tyskland, 48149
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Tyskland, 60590
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Remibrutinib arm

Core Part: Remibrutinib tablet taken orally

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

Remibrutinib (Blinded) active treatment

Andre navne:
  • LOU64
Medicin: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Andre navne:
  • LOU064
Placebo komparator: Placebo arm

Core Part: Placebo tablet taken orally

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

Placebo

Medicin: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Andre navne:
  • LOU064

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline to Month 6 in Quantitative Myasthenia Gravis (QMG) total score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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）
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. februar 2025

Primær færdiggørelse (Anslået)

25. februar 2028

Studieafslutning (Anslået)

26. februar 2033

Datoer for studieregistrering

Først indsendt

17. december 2024

Først indsendt, der opfyldte QC-kriterier

17. december 2024

Først opslået (Faktiske)

20. december 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLOU064O12301
  • 2023-510026-32 (Anden identifikator: EU CTIS)
  • 2023 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner