中等度から重度の活動性潰瘍性大腸炎の小児参加者におけるグセルクマブの研究 (QUASAR Jr)
中等度から重度の活動性潰瘍性大腸炎の小児参加者におけるグセルクマブの有効性、安全性、および薬物動態を評価するための第 3 相ランダム化、非盲検導入、二重盲検維持、並行群間、多施設共同プロトコル
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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California
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Oakland、California、アメリカ、94609
- Children's Hospital Oakland
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Riley Hospital for Children
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New York
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Lake Success、New York、アメリカ、11042
- NYU Langone Health
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Bergamo、イタリア、24127
- ASST Papa Giovanni XXIII Bergamo
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Bologna、イタリア、40133
- Azienda USL di Bologna - Ospedale Maggiore
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Florence、イタリア、50139
- AOU Meyer
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Pescara、イタリア、65124
- Ospedale S. Spirito, Azienda Sanitaria Pescara
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Roma、イタリア、00161
- AOU Policlinico Umberto I
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Roma、イタリア、00165
- IRCCS Ospedale Pediatrico Bambino Gesu
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San Giovanni Rotondo、イタリア、71013
- Casa Sollievo della Sofferenza
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Trieste、イタリア、34137
- IRCCS Materno Infantile Burlo Garofolo
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Nedlands、オーストラリア、6009
- The Kids Research Institute Australia on behalf of the Centre for Child Health Research
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South Brisbane、オーストラリア、4101
- Mater Hospital Brisbane Inflammatory Bowel Diseases
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Westmead、オーストラリア、2145
- The Children's Hospital at Westmead
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Madrid、スペイン、28009
- Hosp. Infantil Univ. Nino Jesus
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Sabadell、スペイン、08028
- Corporacio Sanitari Parc Tauli
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Valencia、スペイン、46026
- Hosp. Univ. I Politecni La Fe
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Aarhus N、デンマーク、8200
- Aarhus Universitetshospital
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Hvidovre、デンマーク、2650
- Hvidovre Hospital
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Ankara、トルコ（Türkiye）、06560
- Gazi University Medical Faculty
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Ankara、トルコ（Türkiye）、6620
- Ankara University Medical Faculty
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Istanbul、トルコ（Türkiye）、34899
- Marmara University Pendik Training Hospital
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Istanbul、トルコ（Türkiye）、34098
- Istanbul University Cerrahpasa Medical Faculty
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Lørenskog、ノルウェー、1478
- Akershus Universitetssykehus
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Oslo、ノルウェー、0450
- Oslo University Hospital
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Tromsø、ノルウェー、9030
- Universitetssykehuset Nord-Norge HF
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Trondheim、ノルウェー、7030
- St. Olavs Hospital
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Bron、フランス、69677
- Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
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Dijon、フランス、21000
- Hopital Francois Mitterand
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Lille、フランス、59037
- CHRU Lille
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Paris、フランス、75019
- APHP Hopital Robert Debre
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Toulouse、フランス、31059
- CHU Toulouse
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Charleroi、ベルギー、6042
- CHU Charleroi Chimay
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Ghent、ベルギー、9000
- UZ Gent
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Jette、ベルギー、1090
- UZ Brussel
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Leuven、ベルギー、3000
- UZ Leuven
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Lisbon、ポルトガル、1649-035
- Uls Santa Maria - Hosp. Santa Maria
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Porto、ポルトガル、4200 319
- Uls Sao Joao - Hosp. Sao Joao
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Porto、ポルトガル、4050-651
- Uls Santo Antonio - Cmin
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Gdansk、ポーランド、80 803
- Copernicus Podmiot Leczniczy Sp. z o.o
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Rzeszów、ポーランド、35-302
- Korczowski Bartosz Gabinet Lekarski
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Warsaw、ポーランド、04 501
- Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
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Warsaw、ポーランド、04 730
- Instytut Pomnik Centrum Zdrowia Dziecka
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Beijing、中国、100191
- Peking University Third Hospital
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Beijing、中国、100020
- Capital Center For Children's health Capital Medical University
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Changzhou、中国、213004
- Changzhou No 2 Peoples Hospital
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Hangzhou、中国、310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hangzhou、中国、310005
- The Childrens Hospital Zhejiang University School Of Medicine
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Shanghai、中国、200025
- Ruijin Hospital Shanghai Jiao Tong University
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Shenyang、中国、110055
- Shengjing Hospital Of China Medical University
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Zhengzhou、中国、450052
- Henan Children's Hospital, Zhengzhou Children's Hospital
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Fuchū、日本、183 8561
- Tokyo Metropolitan Children's Medical Center
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Kanazawa、日本、920 8641
- Kanazawa University Hospital
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Kobe、日本、650 0017
- Kobe University Hospital
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Kumamoto、日本、861 8520
- Japanese Red Cross Kumamoto Hospital
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Matsumoto、日本、390 8621
- Shinshu University Hospital
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Saga、日本、849-8501
- Saga University Hospital
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Setagaya Ku、日本、157 8535
- National Center for Child Health and Development
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Shinjuku、日本、160 0023
- Tokyo Medical University Hospital
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Takatsuki、日本、569-8686
- Osaka Medical and Pharmaceutical University Hospital
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Yokohama、日本、230-8765
- Saiseikai Yokohamashi Tobu Hospital
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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:
- Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
- A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
- Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
- Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
- Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
Exclusion Criteria:
- Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
- Presence of a stoma
- Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
- Have severe colitis or have evidence of Crohn's Disease (CD)
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 |
|---|---|
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実験的：Open-label Induction Phase: Guselkumab Intravenously (IV)
Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase. |
Guselkumab will be administered intravenously.
他の名前：
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実験的：Open-label Induction Phase: Guselkumab Subcutaneously (SC)
Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase. |
Guselkumab will be administered subcutaneously.
他の名前：
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実験的：Double-blind Maintenance Phase: Guselkumab Dose Regimen 1
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56. |
Guselkumab will be administered subcutaneously.
他の名前：
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実験的：Double-blind Maintenance Phase: Guselkumab Dose Regimen 2
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56. |
Guselkumab will be administered subcutaneously.
他の名前：
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実験的：Open-label Maintenance Phase: Guselkumab SC
Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56. |
Guselkumab will be administered subcutaneously.
他の名前：
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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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Percentage of Participants with Clinical Remission at Week 56
時間枠：Week 56
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Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. |
Week 56
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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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Percentage of Participants with Clinical Response at Week 12
時間枠：Week 12
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Percentage of participants with clinical response as assessed by modified Mayo score at Week 12 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. |
Week 12
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Percentage of Participants with Clinical Remission at Week 12
時間枠：Week 12
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Percentage of participants with clinical remission at Week 12 as assessed by modified Mayo score will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. |
Week 12
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Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12
時間枠：Week 12
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Percentage of participants with PUCAI remission at Week 12 will be reported. It comprises 6 scales and ranges between 0 and 85 points. The scales are abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission. |
Week 12
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Percentage of Participants with Symptomatic Remission at Week 12
時間枠：Week 12
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Percentage of participants with symptomatic remission at Week 12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. |
Week 12
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United States: Percentage of Participants with Endoscopic Improvement at Week 12
時間枠：Week 12
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Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 12
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European Union: Percentage of Participants with Endoscopic Healing at Week 12
時間枠：Week 12
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Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 12
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Percentage of Participants with Clinical Response at Week 56
時間枠：Week 56
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Percentage of participants with clinical response as assessed by modified Mayo score at Week 56 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by >= 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. |
Week 56
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Percentage of Participants With PUCAI Remission at Week 56
時間枠：Week 56
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Percentage of participants with PUCAI remission at Week 56 will be reported. PUCAI comprises of 6 scales and ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission. |
Week 56
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Percentage of Participants with Symptomatic Remission at Week 56
時間枠：Week 56
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Percentage of participants with symptomatic remission at Week 56 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. |
Week 56
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Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12
時間枠：Week 56
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Percentage of participants with symptomatic remission at Week 56 among participants who had symptomatic remission at Week 12 will be reported. Symptomatic remission score is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. |
Week 56
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United States: Percentage of Participants With Endoscopic Improvement at Week 56
時間枠：Week 56
|
Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 56
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European Union: Percentage of Participants With Endoscopic Healing at Week 56
時間枠：Week 56
|
Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 56
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Percentage of Participants Who Achieve Endoscopic Normalization at Week 56
時間枠：Week 56
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Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported. |
Week 56
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Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56
時間枠：Week 56
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Percentage of participants histo-endoscopic mucosal healing per endoscopy subscore and histologic improvement at Week 56 will be reported. Histologic-endoscopic mucosal healing is defined as achieving a combination of histologic improvement and endoscopic improvement (US) or endoscopic healing (EU) (endoscopy subscore of 0 or 1). |
Week 56
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Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56
時間枠：Week 56
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Percentage of participants with corticosteroid-free clinical remission at Week 56 will be reported. Corticosteroid free clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline (Week 0), and not receiving corticosteroids for at least 8 weeks prior to Week 56 |
Week 56
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Serum Concentration of Guselkumab During Induction Phase
時間枠：From Week 0 to Week 12
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Serum samples will be analyzed to determine concentrations of guselkumab overtime. |
From Week 0 to Week 12
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Serum Concentration of Guselkumab During Maintenance Phase
時間枠：From Week 12 to Week 56
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Serum samples will be analyzed to determine concentrations of guselkumab over time. |
From Week 12 to Week 56
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Number of Participants with Incidence of Anti-guselkumab Antibodies
時間枠：Up to Week 68
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Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed. |
Up to Week 68
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Percentage of Participants with Adverse Events (AEs)
時間枠：Up to Week 68
|
Percentage of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. |
Up to Week 68
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Percentage of Participants with Serious Adverse Events (SAEs)
時間枠：Up to Week 68
|
Percentage of participants with SAEs will be reported. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. |
Up to Week 68
|
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Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
時間枠：Up to Week 68
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Percentage of participants with AEs leading to discontinuation of study intervention will be reported. |
Up to Week 68
|
協力者と研究者
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- CR109251
- 2022-001285-35 (EudraCT番号)
- CNTO1959PUC3001 (その他の識別子：Janssen Research & Development, LLC)
- 2022-502238-22-00 (レジストリ識別子：EUCT number)
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?
IPD プランの説明
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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。