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Eine Studie zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit von Remibrutinib im Vergleich zu Placebo bei erwachsenen Patienten mit generalisierter Myasthenia gravis (RELIEVE)

25. September 2026 aktualisiert von: Novartis Pharmaceuticals

Eine randomisierte, doppelblinde, placebokontrollierte Phase-III-Studie zur Bewertung der Wirksamkeit, Sicherheit und Verträglichkeit von Remibrutinib bei Patienten mit generalisierter Myasthenia gravis, gefolgt von einer offenen Verlängerungsphase

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

180

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, C1012AAR
        • Novartis Investigative Site
      • Caba, Argentinien, C1055AAF
        • Novartis Investigative Site
      • Capital Federal, Argentinien, C1023AAB
        • Novartis Investigative Site
      • San Miguel de Tucumán, Argentinien, T4000AXL
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentinien, 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
  • 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
  • Deutschland
      • Gummersbach, Deutschland, 51643
        • Novartis Investigative Site
      • Hamburg, Deutschland, 20246
        • Novartis Investigative Site
      • Münster, Deutschland, 48149
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Deutschland, 60590
        • Novartis Investigative Site
  • Frankreich
      • Bordeaux, Frankreich, 33076
        • Novartis Investigative Site
      • Nice, Frankreich, 06000
        • Novartis Investigative Site
      • Paris, Frankreich, 75013
        • Novartis Investigative Site
      • Paris, Frankreich, 75940
        • Novartis Investigative Site
      • Strasbourg, Frankreich, 67081
        • Novartis Investigative Site
      • Toulouse, Frankreich, 31059
        • Novartis Investigative Site
  • Georgia
      • Kutaisi, Georgia, 4600
        • Novartis Investigative Site
      • Tbilisi, Georgia, 0114
        • Novartis Investigative Site
      • Tbilisi, Georgia, 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
  • Niederlande
    • North Holland
      • Amsterdam, North Holland, Niederlande, 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
  • Südkorea
      • Busan, Südkorea, 49241
        • Novartis Investigative Site
      • Seoul, Südkorea, 03080
        • Novartis Investigative Site
      • Seoul, Südkorea, 03722
        • Novartis Investigative Site
      • Seoul, Südkorea, 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
  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85013
        • Neuromuscular Research Center
      • Scottsdale, Arizona, Vereinigte Staaten, 85258
        • Honor Health Research Institute
    • California
      • Fullerton, California, Vereinigte Staaten, 92835
        • Fullerton Neuro and Headache Ctr
      • Los Angeles, California, Vereinigte Staaten, 90033
        • University Of Southern California
      • Sacramento, California, Vereinigte Staaten, 94115
        • California Pacific Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20010-2975
        • Medstar Washington Hospital Center
    • Florida
      • Boca Raton, Florida, Vereinigte Staaten, 33487
        • SFM Clinical Research LLC
      • Homestead, Florida, Vereinigte Staaten, 33033
        • Homestead Assoc In Research Inc
      • Maitland, Florida, Vereinigte Staaten, 32751
        • Neurology Associates PA
      • Orlando, Florida, Vereinigte Staaten, 32804
        • AdventHealth
      • Orlando, Florida, Vereinigte Staaten, 32806
        • Neurological Services of Orlando PA
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60637
        • University of Chicago Medical Centr
    • Maryland
      • Bethesda, Maryland, Vereinigte Staaten, 20817-1807
        • Mid Atlantic Epilepsy and Sleep Ctr
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • Massachusetts General Hospital
    • Michigan
      • East Lansing, Michigan, Vereinigte Staaten, 48824
        • Michigan State University-Department of Neurology
    • New York
      • Buffalo, New York, Vereinigte Staaten, 14209
        • Dent Neurological Institute
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Vereinigte Staaten, 77030
        • UT Health Science Center
      • San Antonio, Texas, Vereinigte Staaten, 78229-3900
        • University of Texas Health Science Center at San Antonio
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98195
        • University of WA Division of Cardio
    • Wisconsin
      • Greenfield, Wisconsin, Vereinigte Staaten, 53228-1321
        • Center for Neurological Disorders G
  • Vereinigtes Königreich
      • London, Vereinigtes Königreich, SW17 0QT
        • Novartis Investigative Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Remibrutinib arm

Core Part: Remibrutinib tablet taken orally

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

Remibrutinib (Blinded) active treatment

Andere Namen:
  • LOU64
Arzneimittel: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Andere Namen:
  • LOU064
Placebo-Komparator: Placebo arm

Core Part: Placebo tablet taken orally

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

Placebo

Arzneimittel: Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Andere Namen:
  • LOU064

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline to Month 6 in Quantitative Myasthenia Gravis (QMG) total score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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）
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Novartis Pharmaceuticals

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

7. Februar 2025

Primärer Abschluss (Geschätzt)

25. Februar 2028

Studienabschluss (Geschätzt)

26. Februar 2033

Studienanmeldedaten

Zuerst eingereicht

17. Dezember 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Dezember 2024

Zuerst gepostet (Tatsächlich)

20. Dezember 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CLOU064O12301
  • 2023-510026-32 (Andere Kennung: EU CTIS)
  • 2023 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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