Safety Study of BIIB033 in Subjects With Multiple Sclerosis
A Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Multiple Sclerosis
The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with MS.
Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will review all safety data from previous groups enrolled, as well as data from another study where BIIB033 is being administered to healthy volunteers (215HV101).
調査の概要
詳細な説明
BIIB033 is a protein that acts on certain types of brain cells by blocking the function of another protein called LINGO-1. It is believed that LINGO-1 is one of the reasons why nerves in the brain of patients with MS do not repair well. It is thought BIIB033 may improve MS by repairing damaged nerve tissue. LINGO-1 is also present in the brain of healthy people.
Subjects will take part in the 215MS101 study for up to 28 weeks. This includes a 4-week screening period, a 2 week treatment period in which 2 doses of BIIB033 are given, and a post-dosing safety follow up period of up to 22 weeks (depending on dose cohort).
The study tests vary at each of the individual visits and may include:
medical history evaluation, height and weight assessment, physical examination, neurological examination, vital signs assessment (pulse, respiratory rate, blood pressure, and temperature), MS performance score, electrocardiogram, cardiac monitoring, routine blood and urine tests, drug concentration testing of the blood, hepatitis and HIV tests, blood clotting tests, brain MRI scan, lumbar puncture, and drugs of abuse screen and pregnancy test.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Colorado
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Centennial、Colorado、アメリカ
- Research Site
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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:
- Give informed consnet
- Aged 18 to 60 years
- Have relapsing remitting MS or secondary progressive MS
- EDSS score of 1 to 6 inclusive
- Body mass index of 18 to 30 kg/m2
- Commitment to use effective contraception 6 months after last dose of study drug Treatment with any interferon beta or glatiramer acetate is allowed to continue during the study as long as the initiation of treatment was at least 3 months and the dose is stable.
Key Exclusion Criteria:
- Primary progressive MS
- Any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, allergic or anaphylactic reactions or other major disease
- Clinically significant lab value at screening outside of normal range
- Clinically significant ECG abnormality
- Contraindication to MRI scans or lumbar punctures
- Plans to undergo elective surgery during study
- An MS relapse that has not resolved within 30 days before screening
- History or postive test result for Hepatitis B, C and HIV
- Serious infections within 3 months prior to Day -1
- Treatment with MS medication within 12 months prior to Day -1: natalizumab, daclizumab, azathioprine, methotrexate, iV immunoglobulin, plasmapheresis or mycophenolate motefil
- Prior treatment with total lymphoid irradiation, T cell or T-cell receptor vaccination, alemtuzumab, mitoxantone, cyclophosphamide, rituximab, fingolimod.
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
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：トリプル
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：Active study drug
Treatment
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IV infusion of 0.3, 1, 3, 10, 30, 60 or 100 mg/kg
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実験的：Comparator
Dummy drug
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IV infusion dummy drug
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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 |
時間枠 |
|---|---|
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Evaluate safety and tolerability profile of two IV infusions of BIIB033 in subjects with MS
時間枠：For duration of study / 6 months
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For duration of study / 6 months
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Identify incidence and types of adverse events
時間枠：For duration of study / 6 months
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For duration of study / 6 months
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The incidence of serious adverse events
時間枠：For duration of study / 6 months
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For duration of study / 6 months
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Changes from baseline in clinical lab assessments and vital signs
時間枠：For duration of study / 6 months
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For duration of study / 6 months
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Changes form baseline in other safety measures: physical and neurological examinations, brain MRIs, and ECGs
時間枠：For duration of study / 6 months
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For duration of study / 6 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Assess the repeat-dose serum PK profile of BIIB033
時間枠：For duration of study / 6 months
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For duration of study / 6 months
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Assess the repeat-dose immunogenicity of BIIB033
時間枠：For duration of study / 6 months
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For duration of study / 6 months
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Measure the concentration of BIIB033 in the cerebrospinal fluid
時間枠：At specified timepoints in the study
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At specified timepoints in the study
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Explore potential biomarkers of BIIB033 activity in the periphery and in the central nervous system
時間枠：At specified timepoints in the study
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At specified timepoints in the study
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Tran JQ, Rana J, Barkhof F, Melamed I, Gevorkyan H, Wattjes MP, de Jong R, Brosofsky K, Ray S, Xu L, Zhao J, Parr E, Cadavid D. Randomized phase I trials of the safety/tolerability of anti-LINGO-1 monoclonal antibody BIIB033. Neurol Neuroimmunol Neuroinflamm. 2014 Aug 21;1(2):e18. doi: 10.1212/NXI.0000000000000018. eCollection 2014 Aug.
- Boyd A, Zhang H, Williams A. Insufficient OPC migration into demyelinated lesions is a cause of poor remyelination in MS and mouse models. Acta Neuropathol. 2013 Jun;125(6):841-59. doi: 10.1007/s00401-013-1112-y. Epub 2013 Apr 18.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 215MS101
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。
BIIB033の臨床試験
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Biogen完了
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Biogen完了
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Biogen終了しました多発性硬化症アメリカ, イタリア, スペイン, ベルギー, ドイツ, スイス, オーストラリア, ハンガリー, フランス, ポーランド, イギリス, チェコ, イスラエル, カナダ, オランダ
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Biogen完了多発性硬化症アメリカ, スペイン, ハンガリー, セルビア, カナダ, フランス, ポーランド, ロシア連邦, オランダ, チェコ共和国, イタリア, イギリス