ミエリンオリゴデンドロサイト糖タンパク質（MOG）抗体関連疾患（MOG-AD）の成人参加者におけるロザノリキシズマブの有効性と安全性を評価する研究 (cosMOG)
ミエリンオリゴデンドロサイト糖タンパク質（MOG）抗体関連疾患（MOG-広告）
The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOGAD).
調査の概要
状態
介入・治療
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Arizona
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Scottsdale、Arizona、アメリカ、85259-5452
- Mog001 50297
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California
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Palo Alto、California、アメリカ、94304
- Mog001 50450
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Colorado
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Aurora、Colorado、アメリカ、80045
- Mog001 50101
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District of Columbia
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Washington D.C.、District of Columbia、アメリカ、20057
- Mog001 50553
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Florida
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Tampa、Florida、アメリカ、33612
- Mog001 50308
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Illinois
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Peoria、Illinois、アメリカ、61637
- Mog001 50472
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Mog001 50552
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Massachusetts
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Boston、Massachusetts、アメリカ、02114-3117
- Mog001 50243
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mog001 50104
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Texas
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San Antonio、Texas、アメリカ、78229
- Mog001 50568
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Utah
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Salt Lake City、Utah、アメリカ、84112
- Mog001 50473
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Liverpool、イギリス
- Mog001 40661
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Oxford、イギリス
- Mog001 40163
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Pavia、イタリア
- Mog001 40146
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Roma、イタリア
- Mog001 40629
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Verona、イタリア
- Mog001 40646
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Kyiv、ウクライナ
- Mog001 20319
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Ternopil、ウクライナ
- Mog001 20228
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Melbourne、オーストラリア
- Mog001 30022
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Athens、ギリシャ
- Mog001 40850
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Basel、スイス
- Mog001 40723
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Bern、スイス
- Mog001 40337
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Zurich、スイス
- Mog001 40630
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Huddinge、スウェーデン
- Mog001 40663
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Barcelona、スペイン
- Mog001 40267
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Madrid、スペイン
- Mog001 40161
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Murcia、スペイン
- Mog001 40350
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Málaga、スペイン
- Mog001 40341
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Seville、スペイン
- Mog001 40049
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Hradec Králové、チェコ
- Mog001 40195
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Teplice、チェコ
- Mog001 40721
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Istanbul、トルコ（Türkiye）
- Mog001 40550
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Izmir、トルコ（Türkiye）
- Mog001 40726
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Samsun、トルコ（Türkiye）
- Mog001 40648
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Sancaktepe、トルコ（Türkiye）
- Mog001 40725
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Göttingen、ドイツ
- Mog001 40140
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Münster、ドイツ
- Mog001 40177
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Strasbourg、フランス
- Mog001 40170
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Porto Alegre、ブラジル
- Mog001 60033
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Ghent、ベルギー
- Mog001 40185
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Coimbra、ポルトガル
- Mog001 40485
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Porto、ポルトガル
- Mog001 40669
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Bydgoszcz、ポーランド
- Mog001 40840
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Culiacán、メキシコ
- Mog001 50486
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Mexico City、メキシコ
- Mog001 50485
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Chiba、日本
- Mog001 20068
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Isehara、日本
- Mog001 20307
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Kitakyushu-shi、日本
- Mog001 20049
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Kodaira、日本
- Mog001 20143
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Koriyama-shi、日本
- Mog001 20223
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Sendai、日本
- Mog001 20224
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Sendai、日本
- Mog001 20227
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Shinjuku-ku、日本
- Mog001 20070
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Suita-shi、日本
- Mog001 20032
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Goyang-si、韓国
- Mog001 20226
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent
- Confirmed diagnosis of MOGAD consistent with published diagnostic criteria for MOGAD
- Participant has history of relapsing MOGAD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization
- Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
Exclusion Criteria:
- Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
- Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP)
- Participant has a current or medical history of primary immunodeficiency
- Participant tests positive for aquaporin-4 antibodies at Screening
- Participant has a serum total IgG level ≤ 5.5g/L
研究計画
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Rozanolixizumab Arm
Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints. |
Participants will receive pre-specified doses of rozanolixizumab.
他の名前：
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プラセボコンパレーター：Placebo Arm
Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding. |
Participants will receive placebo.
他の名前：
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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 |
|---|---|---|
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For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period
時間枠：Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
|
The TTFR (days) will be defined as the interval between the date of randomization and the first date of the objective relapse. During the Double Blind (DB) Treatment Period (Part A); EDB/EWD = End of Double-Blind/Early Withdrawal Visit |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period
時間枠：OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Open-Label Extension (OLE) Treatment Period (Part B); EOS/EWD = End of Study/Early Withdrawal Visit. |
OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period
時間枠：OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported. |
OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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For Part A: Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit
時間枠：Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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Visual acuity is a measurement of the capacity for visual discrimination of fine details. Visual acuity tests are used to determine the smallest characters that can be read on a standardized chart. The Landolt C Broken Ring Chart uses standardized incomplete rings or "C", which are positioned in any direction in the chart (up, down, left, right, and 45 degree positions in between). The participant has to be able to indicate where the break of the "C" is located, by describing the position or by giving gesture. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)
時間枠：Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments with half steps from 1.0 to 9.5. The higher the value the higher is the level of impairment and disability. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part A: Number of MOGAD related inpatient hospitalizations during the DB Treatment Period
時間枠：Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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The total number of MOGAD related hospitalizations from Baseline through EDB/EWD Visit. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period
時間枠：Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
|
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. |
Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)
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For Part B: Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period
時間枠：Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
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An ARR will be calculated for each participant prior to randomization into the Double-Blind Treatment Period (based on available historical data), and 2 ARRs after randomization to study treatment: first for relapses occurring during the Double-Blind Treatment Period and the second for relapses occurring during the OLE Treatment Period. The relapse episodes for each participant will be recorded throughout the entire study. |
Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：UCB Cares、001 844 599 2273
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MOG001
- 2021-000352-19 (EudraCT番号)
- 2023-509237-39 (レジストリ識別子：EU Clinical Trials)
- U1111-1301-0122 (その他の識別子：Universal Trial Number (UTN))
- 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?
IPD プランの説明
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD 共有時間枠
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD 共有アクセス基準
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。