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En studie för att undersöka effektivitet, säkerhet och tolerabilitet av remibrutinib kontra placebo hos vuxna patienter med generaliserad myasthenia gravis (RELIEVE)

25 september 2026 uppdaterad av: Novartis Pharmaceuticals

En randomiserad, dubbelblind, placebokontrollerad fas III-studie för att utvärdera effektivitet, säkerhet och tolerabilitet av remibrutinib hos patienter med generaliserad myasthenia gravis, följt av en öppen förlängningsfas

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Beräknad)

180

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Frankrike
      • Bordeaux, Frankrike, 33076
        • Novartis Investigative Site
      • Nice, Frankrike, 06000
        • Novartis Investigative Site
      • Paris, Frankrike, 75013
        • Novartis Investigative Site
      • Paris, Frankrike, 75940
        • Novartis Investigative Site
      • Strasbourg, Frankrike, 67081
        • Novartis Investigative Site
      • Toulouse, Frankrike, 31059
        • Novartis Investigative Site
  • Förenta staterna
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85013
        • Neuromuscular Research Center
      • Scottsdale, Arizona, Förenta staterna, 85258
        • Honor Health Research Institute
    • California
      • Fullerton, California, Förenta staterna, 92835
        • Fullerton Neuro and Headache Ctr
      • Los Angeles, California, Förenta staterna, 90033
        • University Of Southern California
      • Sacramento, California, Förenta staterna, 94115
        • California Pacific Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, Förenta staterna, 20010-2975
        • Medstar Washington Hospital Center
    • Florida
      • Boca Raton, Florida, Förenta staterna, 33487
        • SFM Clinical Research LLC
      • Homestead, Florida, Förenta staterna, 33033
        • Homestead Assoc In Research Inc
      • Maitland, Florida, Förenta staterna, 32751
        • Neurology Associates PA
      • Orlando, Florida, Förenta staterna, 32804
        • AdventHealth
      • Orlando, Florida, Förenta staterna, 32806
        • Neurological Services of Orlando PA
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
        • University of Chicago Medical Centr
    • Maryland
      • Bethesda, Maryland, Förenta staterna, 20817-1807
        • Mid Atlantic Epilepsy and Sleep Ctr
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Massachusetts General Hospital
    • Michigan
      • East Lansing, Michigan, Förenta staterna, 48824
        • Michigan State University-Department of Neurology
    • New York
      • Buffalo, New York, Förenta staterna, 14209
        • Dent Neurological Institute
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Förenta staterna, 77030
        • UT Health Science Center
      • San Antonio, Texas, Förenta staterna, 78229-3900
        • University of Texas Health Science Center at San Antonio
    • Washington
      • Seattle, Washington, Förenta staterna, 98195
        • University of WA Division of Cardio
    • Wisconsin
      • Greenfield, Wisconsin, Förenta staterna, 53228-1321
        • Center for Neurological Disorders G
  • Georgien
      • Kutaisi, Georgien, 4600
        • Novartis Investigative Site
      • Tbilisi, Georgien, 0114
        • Novartis Investigative Site
      • Tbilisi, Georgien, 0144
        • 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
  • 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
  • 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
  • Nederländerna
    • North Holland
      • Amsterdam, North Holland, Nederländerna, 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
  • Rumänien
      • Brasov, Rumänien, 500283
        • Novartis Investigative Site
      • Bucharest, Rumänien, 040215
        • Novartis Investigative Site
      • Sibiu, Rumänien, 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
  • Storbritannien
      • London, Storbritannien, SW17 0QT
        • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Remibrutinib arm

Core Part: Remibrutinib tablet taken orally

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

Remibrutinib (Blinded) active treatment

Andra namn:
  • LOU64
Läkemedel: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Andra namn:
  • LOU064
Placebo-jämförare: Placebo arm

Core Part: Placebo tablet taken orally

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

Placebo

Läkemedel: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Andra namn:
  • LOU064

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline to Month 6 in Quantitative Myasthenia Gravis (QMG) total score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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）
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 februari 2025

Primärt slutförande (Beräknad)

25 februari 2028

Avslutad studie (Beräknad)

26 februari 2033

Studieregistreringsdatum

Först inskickad

17 december 2024

Först inskickad som uppfyllde QC-kriterierna

17 december 2024

Första postat (Faktisk)

20 december 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CLOU064O12301
  • 2023-510026-32 (Annan identifierare: EU CTIS)
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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