A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis
2016年3月15日 更新者：AbGenomics B.V Taiwan Branch
Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of AbGn-168H Administered by Intravenous Infusion to Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Double-blind, Placebo-controlled)
This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis.
The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients with moderate to severe chronic plaque psoriasis.
調査の概要
研究の種類
介入
入学 (実際)
50
段階
- フェーズ2
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
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Arizona
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Phoenix、Arizona、アメリカ、85032
- Alliance Dermatology & MOHS Center, PC
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Arkansas
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Rogers、Arkansas、アメリカ、72758
- Northwest AR Clinical Trials Center, PLLC.
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Florida
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Ocala、Florida、アメリカ、34471
- Renstar Medical Research
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Port Orange、Florida、アメリカ、32127
- Progressive Medical Research
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Tampa、Florida、アメリカ、33609
- Progressive Medical Research
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Indiana
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Indianaopolis、Indiana、アメリカ、46256
- DawesFretzin Clinical Research Group, LLC.
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New Jersey
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Berlin、New Jersey、アメリカ、08009
- Comprehensive Clinical Research
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New York
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New York、New York、アメリカ、10016
- Manhattan Medical Research Practice PLLC
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Rochester、New York、アメリカ、14623
- Skin Search Of Rochester, Inc.
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North Carolina
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High Point、North Carolina、アメリカ、27265
- High Point Clinical Trials Cente
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Raleigh、North Carolina、アメリカ、27612
- Wake Research Associates
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73112
- Lynn Health Science Institute
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South Carolina
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Greer、South Carolina、アメリカ、29650
- Radiant Research, Inc.
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Texas
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Katy、Texas、アメリカ、77494
- Suzanne Bruce and Associates, P.A., The Center for Skin Research
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Utah
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Salt Lake City、Utah、アメリカ、84132
- University of Utah Dermatology School of Medicine Dermatology 4A330
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-
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～75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:
- Age 18 to 75 (inclusive), males or females
- Body weight < 140 kg
- Patients with stable moderate to severe plaque-type psoriasis, no significant changes within the past 6 months, involving ≥ 10% body surface area, with disease severity PASI ≥ 10 at screening visit and visit 2.
- Psoriasis disease duration of at least 6 months prior to screening
- Patients must be candidates for systemic psoriasis treatment or phototherapy
- Patient must give informed consent and sign an approved consent form prior to any study procedures
- Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Exclusion Criteria:
- Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion)
- HIV infection or a known HIV-related Malignancy.
- Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded.
- Tuberculosis or a positive Tuberculin Skin Test (TST) for tuberculosis. Subjects previously received BCG vaccination or cannot receive TST can participate in the study after showing negative responses in Interferon-Gamma Release Assays (IGRA).
- History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma and carcinoma in situ of the cervix uteri.
- History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
- Use of biologic agents or investigational drug within 8-12 weeks prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to treatment
- Intake of restricted medications or other drugs considered likely to interfere with the safe conduct of the study
- Current alcohol abuse
- Current drug abuse or positive drug screen at screening visit. Subjects with legitimate medically supervised uses of the drugs which are not excluded for other reasons can be enrolled.
- Any blood donation or significant blood loss within 4 weeks prior to Visit 2
- Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial)
Patients with any of the following laboratory values at screening and are considered clinically significant by the investigators:
- Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or neutrophil count, or platelet count < LLN (below the lower limit of the reference normal range)
- ALT, AST and/or total bilirubin > 2.5xULN
- Serum creatinine > 1.5x ULN
- Any clinically significant laboratory abnormalities other than those listed on Exclusion Criteria 14, based on the investigator's medical assessment at screening
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
|
AbGn-168H monoclonal antibody
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実験的：AbGn-168H High Dose
Subject to receive high dose of AbGn-168H intravenously
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AbGn-168H monoclonal antibody
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プラセボコンパレーター：Placebo
Subject to receive placebo intravenously
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Placebo of AbGn-168H
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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 |
|---|---|---|
|
75% reduction in the Psoriasis Area Severity Index (PASI 75)
時間枠：at week 10
|
The primary objective of this study is to investigate efficacy of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo.
|
at week 10
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with abnormal Physical Examination finding
時間枠：At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
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Cmax
時間枠：12 weeks after the first treatment
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Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject
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12 weeks after the first treatment
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Number of participants with Vital Sign change
時間枠：At different time point for 20 weeks after the first treatment
|
At different time point for 20 weeks after the first treatment
|
|
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Number of participants with abnormal ECG finding
時間枠：At different time point for 20 weeks after the first treatment
|
At different time point for 20 weeks after the first treatment
|
|
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Number of participants with abnormal Clinical Laboratory parameters
時間枠：At different time point for 20 weeks after the first treatment
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blood chemistry, hematology and urinalysis
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At different time point for 20 weeks after the first treatment
|
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Number of participants with Adverse Event
時間枠：At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
|
|
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T1/2
時間枠：At different time point for 12 weeks after the first treatment
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At different time point for 12 weeks after the first treatment
|
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。
捜査官
- スタディディレクター：Shih-Yao Lin, MD, Ph.D、AbGenmics B.V. Taiwan Branch
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
2014年5月1日
一次修了 (実際)
2014年12月1日
研究の完了 (実際)
2015年2月1日
試験登録日
最初に提出
2014年5月22日
QC基準を満たした最初の提出物
2014年8月21日
最初の投稿 (見積もり)
2014年8月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年4月14日
QC基準を満たした最後の更新が送信されました
2016年3月15日
最終確認日
2016年3月1日
詳しくは
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。