Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients
A Multi-centre, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of KRP203 in Subjects With Moderately Active Refractory Ulcerative Colitis
This study is designed as a proof of concept of KRP203 for induction of remission in ulcerative colitis (UC). The purpose of this study is to evaluate clinical benefit of KRP203 in subjects with moderately active refractory ulcerative colitis.
The study will provide safety and tolerability data in this subject population up to eight weeks of treatment with KRP203. Additionally, this study will evaluate the duration of a clinical response to KRP203 by following up responding subjects for an additional 12 weeks.
調査の概要
詳細な説明
This is a multi-centre, double-blind, placebo controlled, parallel group, proof of concept study to evaluate the efficacy, safety and tolerability of KRP203 in subjects with moderately active refractory ulcerative colitis subjects. In total, approximately 72 subjects will be randomized into the study.
After 30 patients have completed the 8 week treatment period with KRP203 or placebo, there will be an interim analysis to determine preliminary efficacy. The study will consist of up to 28 day screening period (day -35 to -8), baseline period (day -7 to day -1), treatment period (day 1 to day 56), follow-up period and study completion.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
-
Nottingham、イギリス、NG7 2UH
- Novartis Investigative Site
-
-
Oxfordshire
-
Oxford、Oxfordshire、イギリス、OX3 9DU
- Novartis Investigative Site
-
-
-
-
-
Bern、スイス、3010
- Novartis Investigative Site
-
Zurich、スイス、8091
- Novartis Investigative Site
-
-
-
-
-
Stockholm、スウェーデン、116 91
- Novartis Investigative Site
-
Stockholm、スウェーデン、SE-141 86
- Novartis Investigative Site
-
Uppsala、スウェーデン、751 85
- Novartis Investigative Site
-
-
-
-
-
Frankfurt am Main、ドイツ、60318
- Novartis Investigative Site
-
Hamburg、ドイツ、20148
- Novartis Investigative Site
-
Köln、ドイツ、51103
- Novartis Investigative Site
-
-
-
-
-
Budapest、ハンガリー、1083
- Novartis Investigative Site
-
Debrecen、ハンガリー、4032
- Novartis Investigative Site
-
-
-
-
-
Gent、ベルギー、9000
- Novartis Investigative Site
-
Leuven、ベルギー、3000
- Novartis Investigative Site
-
-
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:
- Active disease defined by partial Mayo score and modified Baron score with disease extending at least 25 cm from the anal verge
- Subjects must have inadequately responded or intolerance to 5-ASA therapy
Exclusion Criteria:
- Subjects receiving treatment for UC (other than 5-ASAs and steroids) within the time frame mentioned in protocol
- Past or recent history of significant medical illness and/or clinically significant lab abnormalities including but not limited to hematology, clinical chemistry, urine analysis, ECG abnormalities, HIV, Hepatitis B/C
- Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, ophthalmic, cardiac, blood, renal, hepatic, infectious, psychiatric or any medically unstable condition, as assessed by the primary treating physician which, in the opinion of the investigator, would immunocompromise the subject and/or place the subject at unacceptable risk for participation in a study of an immunomodulatory therapy Other protocol-defined inclusion/exclusion criteria apply
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
|
|
実験的：KRP203
Experimental Edit Experimental |
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 in clinical remission rate
時間枠：8 weeks
|
Difference between clinical remission rate of subjects on KRP203 versus placebo
|
8 weeks
|
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 Adverse Events as a Measure of Safety and Tolerability
時間枠：8 weeks
|
Safety and tolerability of KRP203 assessed by the number of subjects with adverse events where KRP203 is given as an oral drug for 8 weeks once a day in ulcerative colitis subjects
|
8 weeks
|
|
Pharmacokinetic properties of KRP203 at steady-state using whole blood samples in patients with ulcerative colitis subjects
時間枠：8 weeks
|
8 weeks
|
|
|
Difference in pharmacokinetic levels
時間枠：12 weeks
|
To explore the relationship between KRP203 and KRP203-P pharmacokinetic levels and clinical efficacy outcomes such as the partial Mayo score and endoscopic modified Baron Score
|
12 weeks
|
|
Assessment of the pharmacodynamic effect of KRP203 on absolute lymphocyte count and leukocyte subsets in ulcerative colitis subjects
時間枠：12 weeks
|
12 weeks
|
|
|
Change in markers of inflammation
時間枠：12 weeks
|
Measure of the effect of KRP203 on markers of inflammation, including but not limited to ESR, CRP and fecal calprotectin/ lactoferrin as well as histopathological markers of gut mucosa using biopsy samples in ulcerative colitis subjects
|
12 weeks
|
協力者と研究者
スポンサー
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 (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
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。