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全身性重症筋無力症の成人患者におけるレミブルチニブとプラセボの有効性、安全性、忍容性を調査する研究 (RELIEVE)

2026年9月25日 更新者：Novartis Pharmaceuticals

全身性重症筋無力症患者におけるレミブルチニブの有効性、安全性、忍容性を評価するための無作為化二重盲検プラセボ対照第Ⅲ相試験とその後の非盲検延長相試験

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (推定)

180

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～85年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Remibrutinib arm

Core Part: Remibrutinib tablet taken orally

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

Remibrutinib (Blinded) active treatment

他の名前：
  • LOU64
薬：Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

他の名前：
  • LOU064
プラセボコンパレーター：Placebo arm

Core Part: Placebo tablet taken orally

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

Placebo

薬：Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

他の名前：
  • LOU064

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline to Month 6 in Quantitative Myasthenia Gravis (QMG) total score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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）
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Novartis Pharmaceuticals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年2月7日

一次修了 (推定)

2028年2月25日

研究の完了 (推定)

2033年2月26日

試験登録日

最初に提出

2024年12月17日

QC基準を満たした最初の提出物

2024年12月17日

最初の投稿 (実際)

2024年12月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月28日

QC基準を満たした最後の更新が送信されました

2026年9月25日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CLOU064O12301
  • 2023-510026-32 (その他の識別子：EU CTIS)
  • 2023 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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