( 日本語 ) ギラン バレー症候群に関する疫学研究 ( 英語 )Retrospective epidemiological study of GBS 研究開発分担者 ( 日本語 ) 千葉大学大学院医学研究院神経内科学助教関口縁所属役職氏名 : ( 英語 )Yukari Sekiguchi, Ass
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1 ( 報告様式 4) 課題管理番号 16lk h0003 平成 29 年 5 月 30 日 平成 28 年度委託研究開発成果報告書 I. 基本情報 事 業 名 : ( 日本語 ) 早期探索的 国際水準臨床研究事業 ( 英語 )Early-phase/Exploratory or International-standard Clinical Research Program 研究開発課題名 : ( 日本語 ) ギラン バレー症候群に対するエクリズマブの安全性と有効性を評価する前向き 多施設共同 第 Ⅱ 相試験 ( 英語 )A prospective, multi-center, phase II study to evaluate the safety and efficacy of Eclulizumab in subjects with Guillain-Barré syndrome (GBS): Japanese Eculizumab Trial for GBS (JET-GBS) 研究開発担当者 ( 日本語 ) 千葉大学大学院医学研究院神経内科学教授桑原聡所属役職氏名 :( 英語 )Satoshi Kuwabara, Professor, Department of Neurology, Chiba University Graduate School of Medicine, Chiba University 実施期間 : 平成 28 年 4 月 1 日 ~ 平成 29 年 3 月 31 日 ( 日本語 ) 実施医療機関の調整および医師主導治験の実施に関する研究 ( 英語 )Coordination of clinical sites and conduct of investigator initiated clinical trial 研究開発分担者 ( 日本語 ) 近畿大学医学部神経内科学教授楠進所属役職氏名 : ( 英語 )Susumu Kusunoki, Professor, Department of Neurology, Faculty of Medicine, Kindai University ( 日本語 ) 計画書 概要書 症例報告書の作成に関する研究 ( 英語 )Preparation of protocol, Investigator s Brochure, and case report forms 研究開発分担者 ( 日本語 ) 千葉大学大学院医学研究院神経内科学准教授三澤園子所属役職氏名 : ( 英語 )Sonoko Misawa, Associate Professor, Department of Neurology, Chiba 1
2 ( 日本語 ) ギラン バレー症候群に関する疫学研究 ( 英語 )Retrospective epidemiological study of GBS 研究開発分担者 ( 日本語 ) 千葉大学大学院医学研究院神経内科学助教関口縁所属役職氏名 : ( 英語 )Yukari Sekiguchi, Assistant Professor, Department of Neurology, Chiba ( 日本語 ) 実施体制の調整 (ARO) に関する研究 ( 英語 )Management of system (ARO) to conduct the clinical trial 研究開発分担者 ( 日本語 ) 千葉大学医学部附属病院臨床試験部教授花岡英紀所属役職氏名 : ( 英語 )Hideki Hanaoka, Professor, Chiba University Hospital Clinical Research Center ( 日本語 ) 医師主導治験の実施に関する研究 ( 英語 )Conduct of investigator initiated clinical trial 研究開発分担者 ( 日本語 ) 東京医科歯科大学大学院医歯学総合研究科脳神経病態学教授横田隆徳所属役職氏名 : ( 英語 )Takanori Yokota, Professor, Department of Neurology and Neurological Science, Tokyo Medical and Dental University 研究開発分担者 ( 日本語 ) 神戸市立医療センター中央市民病院神経内科部長幸原伸夫所属役職氏名 : ( 英語 )Nobuo Kohara, Director, Department of Neurology, Kobe City Medical Centre General Hospital 研究開発分担者 ( 日本語 ) 獨協医科大学医学部神経内科教授平田幸一所属役職氏名 : ( 英語 )Koichi Hirata, Professor, Department of Neurology, Dokkyo Medical University 研究開発分担者 ( 日本語 ) 北里大学医学部神経内科学教授西山和利所属役職氏名 : ( 英語 )Kazutoshi Nishiyama, Professor, Department of Neurology, Kitasato University School of Medicine 研究開発分担者 ( 日本語 ) 北海道大学大学院医学研究科神経内科学分野准教授矢部一郎所属役職氏名 : ( 英語 )Ichiro Yabe, Associate Professor, Department of Neurology, Hokkaido 2
3 研究開発分担者 ( 日本語 ) 防衛医科大学校神経内科准教授海田賢一所属役職氏名 : ( 英語 )Ken-ichi Kaida, Associate Professor, Division of Neurology, Department of Internal Medicine, National Defense Medical College 研究開発分担者 ( 日本語 ) 慶應義塾大学医学部神経内科教授鈴木則宏所属役職氏名 : ( 英語 )Norihiro Suzuki, Professor, Department of Neurology, Keio University School of Medicine 研究開発分担者 ( 日本語 ) 徳島大学大学院医歯薬学研究部臨床神経科学分野講師野寺裕之所属役職氏名 : ( 英語 )Hiroyuki Nodera, Senior assistant professor, Department of Clinical Neuroscience, Graduate School of Medical Sciences, Tokushima University 研究開発分担者 ( 日本語 ) 東京大学医学部附属病院神経内科教授辻省次所属役職氏名 : ( 英語 )Shoji Tsuji, Professor, Department of Neurology, The University of Tokyo Graduate School of Medicine 研究開発分担者 ( 日本語 ) 名古屋大学医学部附属病院神経内科准教授小池春樹所属役職氏名 : ( 英語 )Haruki Koike, Associate Professor, Department of Neurology, Nagoya 研究開発分担者 ( 日本語 ) 九州大学大学院医学研究院神経内科学分野教授吉良潤一所属役職氏名 : ( 英語 )Jun-ichi Kira, Professor, Department of Neurology, Neurological Institute, Graduate School of Medical Sciences, Kyushu University, 3
4 II. 成果の概要 ( 総括研究報告 ) 研究開発代表者による報告 研究開発代表者桑原聡 ( 千葉大学医学部附属病院神経内科教授 ) は 楠進 ( 近畿大学医学部附属病院神経内科教授 ) を初めとした 13 施設の研究開発分担者とともに ギラン バレー症候群 (Guillan-Barré syndrome:gbs) の重症患者における 補体 C5 阻害薬であるエクリズマブの安全性及び有効性を探索するための第 Ⅱ 相試験を計画及び実施した GBS は免疫介在性の多発神経炎であり 先進国における急性四肢麻痺の最も一般的な原疾患である GBS の標準治療は免疫グロブリン療法または血漿交換療法であるが 急性期において 18-28% の患者が人工呼吸器の装着が必要になり およそ 5% が死亡する 通常の生活に復帰するには 数ヶ月から数年が必要であり 発症 1 年後においても 約 2 割の症例において 歩行に介助が必要である 従って GBS の生命 機能予後を改善する 新たな治療法の開発が求められている GBS における神経障害が生じるメカニズムとして 補体の活性化が関与する可能性が指摘されている エクリズマブは補体 C5 に対するモノクローナル抗体であり 補体の活性化を強力に阻害する エクリズマブは発作性夜間ヘモグロビン尿症等で 既に実用化されている薬剤である エクリズマブを GBS の急性期に投与することにより 補体の活性化の阻害から神経障害の進展の抑制を図れる可能性がある 本研究の目的は 重症 GBS におけるエクリズマブの安全性と有効性を探索することである 本試験により エクリズマブによる GBS の改善効果が示唆された際には 治験薬の提供元である企業主導の国際共同第 III 相試験を実施し グローバル規模での実用化を進めることを最終的な目標と位置付けている 試験計画は ランダム化二重盲検試験としてデザインした 独歩不能の重症 GBS 患者を 2 群に割付し 標準治療である免疫グロブリン療法に エクリズマブまたはプラセボを上乗せする エクリズマブ群とプラセボ群は 2:1 の比率で割付けを行う 主要評価項目は 4 週時点での独歩可能な症例の割合とし 目標症例数は 33 例に設定した 3 年間 ( 平成 年 ) の研究期間における 上記試験の進捗過程を以下に示す 平成 26 年度は治験開始準備期間として 計画書骨子の立案 治験薬提供者との協議 PMDA との薬事戦略相談 ( 対面助言 ) 参加 13 施設選定 治験実施計画書 SOP 等の整備等を行った 平成 27 年度は治験開始期間として 治験薬提供者との契約 委託業務先の選定 ( モニタリング 監査 割付 症例登録業務 検体回収 保管 ) 治験計画届を提出し試験を開始した また さまざまなリクルート活動を行い 30 症例を登録した 平成 28 年度は予定より 2 ヶ月早く予定登録症例数を満了し 治験総括時期としてデータの固定および解析を行った 治験終了届を提出し 総括報告書案を作成した 試験結果の詳細は 論文及び総括報告書として 今後公表する予定である さらに 国際共同試験の実現に向けて 治験薬提供者と具体的な協議を進める 4
5 Project Outcomes (Summary) Guillain-Barré syndrome (GBS) is an immune-mediated poly neuropathy, which is one of the most common causes of acute tetraparalysis in developed countries. The Japanese Eculizumab Trial for GBS (JET-GBS) is a prospective, multicenter, placebo-controlled, double-blind, randomized phase II study led by the co-chief investigators Satoshi Kuwabara at Chiba University and Susumu Kusunoki at Kindai University, and has been conducted by 13 tertiary neurology centers in Japan. The study aims to evaluate the efficacy and safety of eculizumab in patients with severe GBS. Although plasma exchange or intravenous immunoglobulin has been proved to be effective as the standard treatment for GBS, % of the patients require artificial ventilation and about 5 % of the patients die of complications during the acute phase. Recovery to ordinal life takes several months or years, and around 20 % of the patients still require aid to walk even after one year from onset. Therefore, new treatment options are required to improve the survival and functional recovery. Recent studies suggest that complement activation is closely related to onset of neuropathy in GBS. Eculizumab is a human monoclonal antibody that specifically binds to complement C5 and effectively inhibits its activation, and has been approved for the indication for paroxysmal nocturnal hemoglobinuria. Administration of the drug in the acute phase of GBS may inhibit deteriorating paralysis by inhibiting complement activation cascades. We plan to set a future goal to obtain the indication of eculizumab for GBS globally through an industry-initiated phase Ⅲ study based on the results of this phase II study. This is a randomized double blinded study, and patients who are unable to walk independently were randomized at 2:1 ratio to receive either eculizumab or placebo in conjunction with IVIg. The primary endpoint for efficacy is the proportion of patients who are able to walk without aid at Week 4. The total sample size was set at 33. The progress and outcomes of this project, which has received support of the Japan Agency for Medical Research and Development grant for the duration of the trial ( ), are described as follows. In 2015, we created a synopsis of the study as preparation for the clinical trial. We discussed details of the trial with the investigational drug provider, had regulatory consultations with the Pharmaceuticals and Medical Devices Agency (PMDA), selected 13 participating sites, and finalized the protocol and standard operating procedures. In 2016, in order to initiate the clinical trial, we signed a contract with the drug provider, selected contract research organizations (for monitoring, audit, randomization/registration center, and central laboratories), and submitted the clinical trial notification to PMDA. At the end of the year, 30 patients were enrolled through various activities enhancing recruitment in the trial. In April 2017, we completed the trial for all patients, 2 months earlier than expected, and fixed the data for statistical analysis. The end of study notification was submitted to PMDA and the detailed study results will be disclosed in the clinical study report and a scientific journal. Furthermore, a detailed discussion is expected with the investigational product provider in order to proceed to the next stage for a global multicenter trial. 5
6 研究開発分担者による報告 研究開発代表者 : 国立大学法人千葉大学大学院医学研究院神経内科学桑原聡総括研究報告を参 照 III. 成果の外部への発表 (1) 学会誌 雑誌等における論文一覧 ( 国内誌 0 件 国際誌 1 件 ) 1. Yamaguchi N, Misawa S, Sato Y, Nagashima K, Katayama K, Sekiguchi Y, Iwai Y, Amino H, Suichi T, Yokota T, Nishida Y, Kohara N, Hirata K, Nishiyama K, Yabe I, Kaida KI, Suzuki N, Nodera H, Tsuji S, Koike H, Kira JI, Hanaoka H, Kusunoki S, Kuwabara S, JET-GBS Group A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Eculizumab in Patients with Guillain-Barré Syndrome (GBS): Protocol of Japanese Eculizumab Trial for GBS (JET-GBS) JMIR Res Protoc 2016;5(4):e210 (2) 学会 シンポジウム等における口頭 ポスター発表該当なし (3) 国民との科学 技術対話社会 に対する取り組み該当なし (4) 特許出願当なし 6
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