中等度から重度の潰瘍性大腸炎における経口 NX-13 の臨床活性と安全性を評価するための研究
中等度から重度の潰瘍性大腸炎を伴う参加者における経口NX-13の臨床活性と安全性を評価するための長期延長を伴う無作為化、二重盲検、プラセボ対照、複数回投与、多施設第2相導入試験
調査の概要
詳細な説明
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
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Florida
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Miami、Florida、アメリカ、33155
- Miami Clinical Research
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Orlando、Florida、アメリカ、32806
- Orlando Health, Inc.
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Tampa、Florida、アメリカ、33609
- GCP Clinical Research
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Michigan
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Chesterfield、Michigan、アメリカ、48047
- Digestive Health Center of Michigan
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Troy、Michigan、アメリカ、48098
- Clinical Research Institute of Michigan
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Missouri
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St Louis、Missouri、アメリカ、63110
- Washington University School of Medicine in St. Louis
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73112
- Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center
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Texas
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Garland、Texas、アメリカ、75044
- Digestive Health Associates of Texas-GI Alliance Research-Garland
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Mansfield、Texas、アメリカ、76003
- Digestive Health Associates of Texas-GI Alliance
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Southlake、Texas、アメリカ、76092
- Texas Digestive Disease Consultants-GI Alliance Research
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin
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Milan、イタリア
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
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Roma、イタリア
- Azienda Ospedaliera - Universitaria Sant' Andrea
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Rozzano、イタリア
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
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San Giovanni Rotondo、イタリア
- IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
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Torino、イタリア
- Azienda Ospedaliera Ordine Mauriziano Di Torino
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Leuven、ベルギー
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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Bydgoszcz、ポーランド
- ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy
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Bydgoszcz、ポーランド
- Przychodnia Vitamed NFZ
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Jelenia Góra、ポーランド
- Amicare Centrum Medyczne
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Katowice、ポーランド
- VITA LONGA Clinic - Katowice
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Krakow、ポーランド
- Krakowska Przychodnia FutureMeds
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Lodz、ポーランド
- Amicare Sp. z o.o. Sp.k.
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Opoczno、ポーランド
- Amicare Sp z o.o. S.K
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Opole、ポーランド
- Twoja Przychodnia Opolskie Centrum Medyczne
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Poznan、ポーランド
- RiverMED Poradnie Specjalistyczne Poznań
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Sopot、ポーランド
- Endoskopia Sp. z o.o.
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Szczecin、ポーランド
- Sonomed Sp. z o.o. Centrum Medyczne
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Szczecin、ポーランド
- Twoja Przychodnia Szczecińskie Centrum Medyczne
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Torun、ポーランド
- Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
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Tychy、ポーランド
- H-T Centrum Medyczne
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Warsaw、ポーランド
- Office of Jaroslaw Kierkus, Dr N Med
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Wroclaw、ポーランド
- Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
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Wroclaw、ポーランド
- Zabobrze Centrum Medyczne
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Włocławek、ポーランド
- Centrum Diagnostyczno - Lecznicze Barska
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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
説明
包含基準:
- 18歳から75歳までの成人被験者
- -組織学的証拠によって確認されたスクリーニングの90日以上前のUCの診断
- -アクティブなUCは、ベースラインで5以上（包括的）の合計メイヨースコア（MMS）として定義されます
- -無作為化前の14日以内にES≧2
- RBS≧1。
除外基準:
- -医師の判断によって証明される重度の広範囲の大腸炎 参加者は無作為化後12週間以内に、UCに対する医療またはあらゆる種類の外科的介入（結腸切除術など）のために入院を必要とする可能性が高い。
- -劇症大腸炎、中毒性巨大結腸の現在の証拠、または中毒性巨大結腸の最近の病歴（スクリーニング前6か月以内）、または腸穿孔
- -クローン病（CD）または不確定な大腸炎の診断、またはCDと一致する瘻孔の存在または病歴
- 顕微鏡的大腸炎、虚血性大腸炎、または放射線大腸炎の診断
- 細菌または寄生虫の病原性腸管感染;
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：NX-13 250mg
被験者は、一貫性のために毎日同時に推奨される1日3錠を摂取することにより、治験薬を服用します。
NX-13 グループの被験者は 3 錠で 250 mg または 750 mg の NX-13 を受け取り、プラセボ グループの被験者は対応するプラセボを受け取ります。
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NX-13 250mg 錠、プラセボ錠 2 錠
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実験的：NX-13 750mg
被験者は、一貫性のために毎日同時に推奨される1日3錠を摂取することにより、治験薬を服用します。
NX-13 グループの被験者は 3 錠で 250 mg または 750 mg の NX-13 を受け取り、プラセボ グループの被験者は対応するプラセボを受け取ります。
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NX-13 250mg 錠 × 3 で 750mg
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プラセボコンパレーター：NX-13 プラセボ
被験者は、一貫性のために毎日同時に推奨される1日3錠を摂取することにより、治験薬を服用します。
NX-13 グループの被験者は 3 錠で 250 mg または 750 mg の NX-13 を受け取り、プラセボ グループの被験者は対応するプラセボを受け取ります。
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NX-13 プラセボ錠 盲目的に 3 倍
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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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Change From Baseline in Modified Mayo Score (MMS) at Week 12
時間枠：Baseline, Week 12
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The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency [SFS], rectal bleeding [RBS] and finding on endoscopy [ES]), each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
A negative change in MMS score indicates improvement.
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Baseline, Week 12
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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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Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Induction Period
時間枠：Baseline up to Week 12
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Treatment-emergent adverse events (TEAEs) were defined as AEs that occurred after the participant received first dose of study treatment or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment until 21 days after the date and time of last dose of study drug.
A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.
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Baseline up to Week 12
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Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Induction Period
時間枠：Baseline up to Week 12
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SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition.
A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.
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Baseline up to Week 12
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Number of Participants With Clinical Remission Per MMS at Week 12
時間枠：Week 12
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Clinical Remission per MMS was defined as achieving MMS <=2, with RBS =0, SFS <=1 and not greater than baseline, and ES <=1. The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES), each of which ranges from 0 (normal) to 3 (severe disease). A lower MMS indicates better health status. |
Week 12
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Number of Participants With MMS <=2 at Week 12
時間枠：Week 12
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The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES), each of which ranges from 0 (normal) to 3 (severe disease).
A lower MMS indicates better health status.
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Week 12
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Number of Participants With Robarts Histopathology Index (RHI) Score <=3 at Week 12
時間枠：Week 12
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The Robarts Histopathology Index (RHI) score is used to assess the disease severity.
The RHI is defined as the sum of four weighted items from Geboes: Grade 1: lamina propria chronic inflammation; Grade 2B: lamina propria neutrophils; Grade 3: epithelial neutrophils; Grade 5: surface epithelial injury.
Total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity) with a higher score indicating more severity.
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Week 12
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Number of Participants With Clinical Response Per MMS at Week 12
時間枠：Baseline, Week 12
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Clinical Response was defined as >=2 Points and >=30% decrease from baseline in MMS with >=1 point decrease in RBS or RBS <=1. The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES) each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. |
Baseline, Week 12
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Number of Participants With Endoscopic Response at Week 12
時間枠：Week 12
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Endoscopic Response was defined as ES <=1. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. |
Week 12
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Number of Participants With Endoscopic Remission at Week 12
時間枠：Week 12
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Endoscopic Remission was defined as ES =0. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. |
Week 12
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Number of Participants With Endoscopic-histologic Mucosal Improvement at Week 12
時間枠：Week 12
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Endoscopic-histologic Mucosal Improvement was defined as ES <=1 and Geboes score <2.0. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status. |
Week 12
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Number of Participants With Histologic Endoscopic Mucosal Improvement (HEMI) at Week 12
時間枠：Week 12
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HEMI was defined as ES <=1 and Geboes score <3.1. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status. |
Week 12
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Number of Participants With Histologic Endoscopic Mucosal Remission (HEMR) at Week 12
時間枠：Week 12
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HEMR was defined as ES = 0 and Geboes score <2.0. The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status. |
Week 12
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Number of Participants With Symptomatic Remission at Week 12
時間枠：Baseline, Week 12
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Symptomatic remission was defined as RBS = 0 and (i) SFS = 0 or (ii) SFS = 1 with baseline SFS >2, at Week 12. The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES) each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. |
Baseline, Week 12
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Number of Participants With Clinical Response Per Partial MMS at Week 4
時間枠：Baseline, Week 4
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Clinical response per partial MMS was defined as achieving >=1 points and >=30% decrease from baseline in partial MMS, with >=1 point decrease in RBS or RBS <=1. Partial MMS ranges from 0 (normal or inactive disease) to 6 (severe disease) and is calculated as the sum of 2 subscores (SFS and RBS), each of which ranges from 0 (normal) to 3 (severe disease). A lower partial MMS indicates better health status. |
Baseline, Week 4
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Number of Participants With Abdominal Pain Score = 0 at Week 12
時間枠：Week 12
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Participants rated their abdominal pain on a scale from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating more pain.
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Week 12
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Number of Participants With Rectal Urgency Score = 0 at Week 12
時間枠：Week 12
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The rectal urgency score is based on the number of times participants must rush to the toilet to have a bowel movement.
The score ranges from 0 (2 or fewer events) to 10 (12 or more events), with higher scores representing more severe symptoms.
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Week 12
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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：AbbVie、AbbVie
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
- NX-13-201
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?
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
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。