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潰瘍性大腸炎の若い参加者でリサンキズマブがどのように機能するかについて詳しく知るための研究 (MIGHTY)

2026年10月23日 更新者：AbbVie

無盲検誘導、無作為化二重盲検維持、および小児科被験者（2〜18歳<18歳）のリサンキズマブの薬物動態、有効性、および安全性を評価するためのフェーズ3のマルチセンター研究。

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.

Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide.

Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

120

段階

  • フェーズ 3

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。

研究連絡先

研究場所

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85016
        • 募集
        • Phoenix Children's Hospital /ID# 273015
    • California
      • San Diego、California、アメリカ、92123
        • 募集
        • Rady Children's Hospital /ID# 271873
      • San Francisco、California、アメリカ、94158
        • 募集
        • University of California San Francisco - Mission Bay /ID# 273022
    • Florida
      • Miami、Florida、アメリカ、33155
        • 募集
        • Nicklaus Children's Hospital - Miami /ID# 271585
    • Georgia
      • Atlanta、Georgia、アメリカ、30342
        • 募集
        • Childrens Center For Digestive Health Care /ID# 273228
    • Illinois
      • Chicago、Illinois、アメリカ、60637
        • 募集
        • University of Chicago Medical Center /ID# 271588
    • New Jersey
      • Morristown、New Jersey、アメリカ、07962
        • 募集
        • Goryeb Children's Hospital /ID# 271801
    • Ohio
      • Cleveland、Ohio、アメリカ、44106
        • 募集
        • University Hospitals Cleveland Medical Center /ID# 271831
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • 募集
        • The Children's Hospital of Philadelphia /ID# 273222
      • Pittsburgh、Pennsylvania、アメリカ、15224
        • 募集
        • Upmc Children'S Hospital Of Pittsburgh /ID# 272328
    • South Carolina
      • Greenville、South Carolina、アメリカ、29615
        • 募集
        • Patewood Medical Campus /ID# 272477
    • Texas
      • Dallas、Texas、アメリカ、75235
        • 募集
        • University of Texas - Southwestern Medical Center /ID# 271835
  • イギリス
      • Liverpool、イギリス、L12 2AP
        • 募集
        • Alder Hey Children's NHS Foundation Trust /ID# 271533
    • Cambridgeshire
      • Cambridge、Cambridgeshire、イギリス、CB2 2QQ
        • 募集
        • Addenbrookes Hospital /ID# 271489
    • England
      • Sheffield、England、イギリス、S10 2TH
        • 募集
        • Sheffield Children's Hospital NHS Foundation Trust /ID# 271490
  • イタリア
      • Trieste、イタリア、34137
        • 募集
        • Ospedale Infantile Burlo Garofolo /ID# 274442
    • Foggia
      • San Giovanni Rotondo、Foggia、イタリア、71013
        • 募集
        • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889
    • Napoli
      • Naples、Napoli、イタリア、80131
        • 募集
        • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895
    • Roma
      • Rome、Roma、イタリア、00168
        • 募集
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T3B 6A8
        • 募集
        • Alberta Children's Hospital /ID# 272635
      • Edmonton、Alberta、カナダ、T6G 2B7
        • 募集
        • University of Alberta Hospital /ID# 271168
    • Ontario
      • London、Ontario、カナダ、N6A 5W9
        • 募集
        • London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157
  • ギリシャ
      • Thessaloniki、ギリシャ、54642
        • 募集
        • General Hospital of Thessaloniki Hippokrateio /ID# 271939
    • Attica
      • Athens、Attica、ギリシャ、11527
        • 募集
        • Thoracic General Hospital of Athens I Sotiria /ID# 270143
      • Chaïdári、Attica、ギリシャ、12462
        • 募集
        • University General Hospital Attikon /ID# 272361
  • スウェーデン
    • Stockholm County
      • Solna、Stockholm County、スウェーデン、171 64
        • 募集
        • Karolinska University Hospital Solna /ID# 271679
      • Stockholm、Stockholm County、スウェーデン、118 83
        • 募集
        • Sodersjukhuset /ID# 271678
    • Västra Götaland County
      • Gothenburg、Västra Götaland County、スウェーデン、413 46
        • 募集
        • Sahlgrenska Universitetssjukhuset /ID# 271675
        • コンタクト：
          • Site Coordinator
          • 電話番号：+46313435865
  • スペイン
    • A Coruna
      • A Coruña、A Coruna、スペイン、15006
        • 募集
        • Hospital Teresa Herrera - CHUAC /ID# 271459
    • Madrid
      • Majadahonda、Madrid、スペイン、28222
        • 募集
        • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
  • セルビア
      • Novi Sad、セルビア、21000
        • 募集
        • Institute for Child and Youth Health Care of Vojvodina /ID# 269961
    • Beograd
      • Belgrade、Beograd、セルビア、11000
        • 募集
        • University Children's Hospital /ID# 269960
      • Belgrade-Vračar、Beograd、セルビア、11000
        • 募集
        • Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
  • ドイツ
    • Brandenburg
      • Cottbus、Brandenburg、ドイツ、03048
        • 募集
        • Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023
    • Hesse
      • Kassel、Hesse、ドイツ、34125
        • 募集
        • Klinikum Kassel /ID# 271546
    • North Rhine-Westphalia
      • Münster、North Rhine-Westphalia、ドイツ、48149
        • 募集
        • Universitaetsklinikum Muenster /ID# 271898
  • ブラジル
      • São Paulo、ブラジル、01308-050
        • 募集
        • Hospital Sirio Libanes - Sao Paulo /ID# 271818
    • Minas Gerais
      • Juiz de Fora、Minas Gerais、ブラジル、36033-318
        • 募集
        • Galileo Medical Research /ID# 271817
    • Paraná
      • Curitiba、Paraná、ブラジル、80250-060
        • 募集
        • Hospital Pequeno Principe /ID# 271814
  • ベルギー
      • Brussels、ベルギー、1020
        • 募集
        • Hospital Universite Enfants Reine Fabiola /ID# 271860
      • Liège、ベルギー、4000
        • 募集
        • Centre Hospitalier Regional de la Citadelle /ID# 270459
    • Brussels Capital
      • Brussels、Brussels Capital、ベルギー、1200
        • 募集
        • Cliniques Universitaires UCL Saint-Luc /ID# 270123
  • ポーランド
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、ポーランド、00-189
        • 募集
        • Centrum Zdrowia Mdm /ID# 276942
      • Warsaw、Masovian Voivodeship、ポーランド、00-728
        • 募集
        • Medical Network Sp. z o.o. /ID# 276903
    • Podlaskie Voivodeship
      • Bialystok、Podlaskie Voivodeship、ポーランド、15-274
        • 募集
        • Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku /ID# 276771
  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国、510620
        • 募集
        • Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962
    • Henan
      • Zhengzhou、Henan、中国、450018
        • 募集
        • Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794
    • Hunan
      • Changsha、Hunan、中国、410007
        • 募集
        • Hunan Children's Hospital /ID# 278111
    • Jilin
      • Changchun、Jilin、中国、130021
        • 募集
        • The First Hospital of Jilin University - Changchun /ID# 279290
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200025
        • 募集
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310018
        • 募集
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994
      • Hangzhou、Zhejiang、中国、310056
        • 募集
        • The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815
  • 台湾
      • Taichung、台湾、407219
        • 募集
        • Taichung Veterans General Hospital /ID# 269242
      • Taipei、台湾、100
        • 募集
        • National Taiwan University Hospital /ID# 269244
  • 日本
      • Fukushima、日本、960-1295
        • 募集
        • Fukushima Medical University Hospital /ID# 281178
    • Aichi-ken
      • Ōbu、Aichi-ken、日本、474-8710
        • 募集
        • Aichi Children's Health And Medical Center /ID# 280462
    • Chiba
      • Kashiwa-shi、Chiba、日本、277-0871
        • 募集
        • Tsujinaka Hospital - Kashiwanoha /ID# 280303
    • Fukuoka
      • Kurume-shi、Fukuoka、日本、830-0011
        • 募集
        • Kurume University Hospital /ID# 280792
    • Gunma
      • Maebashi、Gunma、日本、371-8511
        • 募集
        • Gunma University Hospital /ID# 281179
    • Hyōgo
      • Kobe、Hyōgo、日本、650-0017
        • 募集
        • Kobe University Hospital /ID# 281796
    • Kumamoto
      • Kumamoto、Kumamoto、日本、861-8520
        • 募集
        • Japanese Red Cross Kumamoto Hospital /ID# 280696
    • Saga-ken
      • Saga、Saga-ken、日本、849-8501
        • 募集
        • Saga University Hospital /ID# 281232
    • Saitama
      • Saitama-shi、Saitama、日本、330-8777
        • 募集
        • Saitama Children's Medical Center /ID# 280603
    • Shizuoka
      • Hamamatsu、Shizuoka、日本、431-3192
        • 募集
        • Hamamatsu University Hospital /ID# 281614
    • Tokyo
      • Bunkyo-ku、Tokyo、日本、113-8519
        • 募集
        • Institute of Science Tokyo Hospital /ID# 280694
      • Bunkyo-ku、Tokyo、日本、113-8431
        • 募集
        • Juntendo University Hospital /ID# 280463
      • Fuchu-shi、Tokyo、日本、183-8561
        • 募集
        • Tokyo Metropolitan Children's Medical Center /ID# 280791
      • Setagaya City、Tokyo、日本、157-8535
        • 募集
        • National Center For Child Health And Development /ID# 280460
  • 韓国
    • Gyeongsangnam-do
      • Yangsan、Gyeongsangnam-do、韓国、50612
        • 募集
        • Pusan National University Yangsan Hospital /ID# 272769
    • Seoul Teugbyeolsi
      • Seoul、Seoul Teugbyeolsi、韓国、03080
        • 募集
        • Seoul National University Hospital /ID# 272852
      • Seoul、Seoul Teugbyeolsi、韓国、06351
        • 募集
        • Samsung Medical Center /ID# 272862
      • Seoul、Seoul Teugbyeolsi、韓国、03181
        • 募集
        • Kangbuk Samsung Hospital /ID# 273333
      • Seoul、Seoul Teugbyeolsi、韓国、03722
        • 募集
        • Yonsei University Health System - Severance Hospital /ID# 272894

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

2年～17年 (子)

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:

  • Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
  • Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:

aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.

- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.

Exclusion Criteria:

  • Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).
  • Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.

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：順次割り当て
  • 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
実験的：PK Cohort 1: SS1

Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：PK Cohort 1: SS2 Dose A

Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：PK Cohort 1: SS2 Dose B

Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：PK Cohort 1: SS3 Dose A

Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：PK Cohort 1: SS3 Dose B

Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：PK Cohort 2: SS1

Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：PK Cohort 2: SS2 Dose A

Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：PK Cohort 2: SS2 Dose B

Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：PK Cohort 2: SS3 Dose A

Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：PK Cohort 2: SS3 Dose B

Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：Expansion Cohort 3: SS1

Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：Expansion Cohort 3: SS2 Dose A

Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：Expansion Cohort 3: SS2 Dose B

Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：Expansion Cohort 3: SS3 Dose A

Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066
実験的：Expansion Cohort 3: SS3 Dose B

Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
薬：Risankizumab

Risankizumab intravenous (IV) infusion

他の名前：
  • ABBV-066
薬：Risankizumab

Risankizumab subcutaneous (SC) injection

他の名前：
  • ABBV-066

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
PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)
時間枠：At Week 64

Maximum observed plasma concentration (Cmax)
At Week 64
PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)
時間枠：At Week 64

Maximum observed plasma concentration (Cmax)
At Week 64
PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)
時間枠：At Week 64

Time to maximum plasma concentration (Tmax)
At Week 64
PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)
時間枠：At Week 64

Time to maximum plasma concentration (Tmax)
At Week 64
PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
時間枠：At Week 64

Area under the serum concentration-time curve over the dosing interval (AUCtau)
At Week 64
PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
時間枠：At Week 64

Area under the serum concentration-time curve over the dosing interval (AUCtau)
At Week 64
Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS
時間枠：At Week 64

Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
At Week 64
Number of Participants With Adverse Events
時間枠：Up to 292 Weeks

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related
Up to 292 Weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
拡張コホート3：mmsあたりの臨床寛解の達成
時間枠：12週目
12週目
拡張コホート3：mmsあたりの臨床反応の達成
時間枠：12週目
12週目
拡張コホート3：内視鏡改善の達成
時間枠：12週目
12週目
拡張コホート3：部分MMSごとの症候性反応
時間枠：12週目
12週目
拡張コホート3：MMSあたり12週目のレスポンダーにおけるMMSあたりの臨床反応の達成
時間枠：64週目
64週目
拡張コホート3：MMSあたり12週目のレスポンダーにおける内視鏡改善の達成
時間枠：64週目
64週目
拡張コホート3：12週目のレスポンダーにおけるMMSあたりのコルチコステロイドのない臨床寛解の達成
時間枠：64週目
64週目
PK Lead-In Cohort 1: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS
時間枠：Up to Week 64
Up to Week 64
PK Lead-In Cohort 2: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS
時間枠：Up to Week 64
Up to Week 64
PK Lead-In Cohort 1: Achievement of clinical remission per mMS among Week 12 responders per mMS
時間枠：At Week 64

Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
At Week 64
PK Lead-In Cohort 2: Achievement of clinical remission per mMS among Week 12 responders per mMS
時間枠：At Week 64

Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
At Week 64
PK Lead-In Cohort 1: Achievement of clinical remission per mMS
時間枠：At Week 12

Clinical remission on the mMS is defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
At Week 12
PK Lead-In Cohort 2: Achievement of clinical remission per mMS
時間枠：At Week 12

Clinical remission on the mMS is defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
At Week 12
PK Lead-In Cohort 1: Achievement of clinical response per mMS
時間枠：At Week 12

Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.
At Week 12
PK Lead-In Cohort 2: Achievement of clinical response per mMS
時間枠：At Week 12

Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.
At Week 12
PK Lead-In Cohort 1: Achievement of endoscopic improvement
時間枠：At Week 12

Endoscopic improvement defined as MES ≤ 1
At Week 12
PK Lead-In Cohort 2: Achievement of endoscopic improvement
時間枠：At Week 12

Endoscopic improvement defined as MES ≤ 1
At Week 12
PK Lead-In Cohort 1: Symptomatic response per partial mMS
時間枠：At Week 12

Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1.
At Week 12
PK Lead-In Cohort 2: Symptomatic response per partial mMS
時間枠：At Week 12

Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1.
At Week 12
PK Lead-In Cohort 1: Achievement of clinical response per mMS among Week 12 responders per mMS
時間枠：At Week 64

Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.
At Week 64
PK Lead-In Cohort 2: Achievement of clinical response per mMS among Week 12 responders per mMS
時間枠：At Week 64

Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.
At Week 64
PK Lead-In Cohort 1: Achievement of endoscopic improvement among Week 12 responders per mMS
時間枠：At Week 64

Endoscopic improvement defined as MES ≤ 1
At Week 64
PK Lead-In Cohort 2: Achievement of endoscopic improvement among Week 12 responders per mMS
時間枠：At Week 64

Endoscopic improvement defined as MES ≤ 1
At Week 64

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AbbVie

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便利なリンク

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 (実際)

2025年7月28日

一次修了 (推定)

2034年7月1日

研究の完了 (推定)

2034年7月1日

試験登録日

最初に提出

2025年7月8日

QC基準を満たした最初の提出物

2025年7月8日

最初の投稿 (実際)

2025年7月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月27日

QC基準を満たした最後の更新が送信されました

2026年10月23日

最終確認日

2026年10月1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

  • M19-751
  • 2024-514695-41-00 (Ctis)

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?

はい

IPD プランの説明

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD 共有時間枠

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD 共有アクセス基準

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

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