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クローン病患者におけるグセルクマブの経壁治癒および疾患修飾効果 (REASON)

2026年11月2日 更新者：Janssen-Cilag Ltd.

クローン病患者におけるグセルクマブの経壁治癒および疾患修飾効果を評価するための第 3b 相、単群、非盲検、多施設共同研究

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

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。

研究場所

  • アメリカ
    • California
      • San Francisco、California、アメリカ、94115
        • Center for Colitis and Crohns Disease University of California
    • Illinois
      • Chicago、Illinois、アメリカ、60637
        • The University of Chicago Medical Center (UCMC)
    • Missouri
      • St Louis、Missouri、アメリカ、63110
        • Washington University School Of Medicine
    • South Carolina
      • Charleston、South Carolina、アメリカ、29425
        • Medical University of South Carolina
  • イスラエル
      • Haifa、イスラエル、31096
        • Rambam Medical Center
      • Holon、イスラエル、58100
        • The Edith Wolfson Medical Center
      • Jerusalem、イスラエル、91200
        • Hadassah Medical Organization
      • Nahariya、イスラエル、2210001
        • Galilee Medical Center
      • Petah Tikva、イスラエル、49100
        • Rabin Medical Center
      • Ramat Gan、イスラエル、5265601
        • The Chaim Sheba Medical Center
      • Tel Aviv、イスラエル、6423906
        • Tel Aviv Sourasky Medical Center
  • イタリア
      • Bologna、イタリア、40138
        • Azienda Ospedaliera Policlinico S. Orsola-Malpighi
      • Milan、イタリア、20132
        • IRCCS Ospedale San Raffaele
      • Milan、イタリア、20121
        • ASST Fatebenefratelli Sacco
      • Naples、イタリア、80131
        • Universita Di Napoli Federico Ii
      • Pontedera Pisa、イタリア、56025
        • ASL Toscana Nord Ovest PO Valdera Ospedale Lotti
      • Rho、イタリア、20017
        • Asst Rhodense - Ospedale Di Rho
      • Roma、イタリア、00133
        • Fondazione Policlinico Tor Vergata
      • Roma、イタリア、00168
        • Fondazione Policlinico Universitario A Gemelli IRCCS
      • Roma、イタリア、00128
        • Universita Campus Bio-Medico di Roma
      • Rozzano、イタリア、20089
        • IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
      • San Giovanni Rotondo、イタリア、71013
        • IRCCS Ospedale Casa Sollievo della Sofferenza
  • オーストラリア
      • Adelaide、オーストラリア、5011
        • The Queen Elizabeth Hospital
      • Concord、オーストラリア、2139
        • Concord Repatriation General Hospital
      • Melbourne、オーストラリア、3076
        • Northern Hospital
      • Murdoch、オーストラリア、6150
        • Fiona Stanley Hospital
      • South Brisbane、オーストラリア、4101
        • Mater Hospital Brisbane
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2N 4Z6
        • Foothills Hospital
    • Ontario
      • London、Ontario、カナダ、N6A 5A5
        • Western University & London Health Sciences Centre
    • Quebec
      • Montreal、Quebec、カナダ、H4J 1C5
        • Hopital du Sacre-Coeur de Montreal
  • スペイン
      • Alicante、スペイン、3010
        • Hosp. Gral. Univ. Dr. Balmis
      • Córdoba、スペイン、14004
        • Hosp Reina Sofia
      • Ferrol、スペイン、15405
        • Complejo Hosp Univ. de Ferrol
      • Ferrol、スペイン、15405
        • Hosp. Univ. de La Paz
      • Madrid、スペイン、28006
        • Hosp. Univ. de La Princesa
      • Madrid、スペイン、28222
        • Hosp. Univ. Pta. de Hierro Majadahonda
      • Valencia、スペイン、46010
        • Hosp. Clinico Univ. de Valencia
      • Vigo、スペイン、36213
        • Hosp. Alvaro Cunqueiro
  • スロバキア
      • Banská Bystrica、スロバキア、975 17
        • FNsP F.D.R. Banska Bystrica
      • Bratislava、スロバキア、811 09
        • Cliniq s.r.o.
      • Košice、スロバキア、040 13
        • ENDOMED s.r.o
      • Nitra、スロバキア、949 01
        • KM Management spol. s r.o.
      • Prešov、スロバキア、080 01
        • GASTRO I. s.r.o.
  • チェコ
      • Hradec Králové、チェコ、500 12
        • Hepato-gastroenterologie HK, s.r.o.
      • Prague、チェコ、19000
        • ISCARE a.s.
      • České Budějovice、チェコ、370 87
        • Nemocnice Ceske Budejovice a s
  • ドイツ
      • Augsburg、ドイツ、D-86158
        • Klinikum Augsburg
      • Berlin、ドイツ、10117
        • Charite Universitaetsmedizin Berlin
      • Berlin、ドイツ、10825
        • Praxis Fur Gastroenteroligie
      • Dachau、ドイツ、85221
        • Medizinisches Versorgungszentrum (MVZ) Dachau
      • Frankfurt、ドイツ、60590
        • Universitatsklinikum Frankfurt/ Medizinische Klinik 1
      • Göttingen、ドイツ、37075
        • Universitatsmedizin Gottingen
      • Halle、ドイツ、06108
        • Studiengesellschaft Mitteldeutschland GmbH
      • Hanover、ドイツ、30625
        • Medizinische Hochschule Hannover
      • Kiel、ドイツ、24105
        • Universitatsklinikum Schleswig Holstein
      • Lüneburg、ドイツ、21339
        • Staedtisches Klinikum Lueneburg
      • Münster、ドイツ、48155
        • MVZ Portal 10
      • Pforzheim、ドイツ、75179
        • Siloah St Trudpert Klinikum
      • Ulm、ドイツ、89081
        • Universitaetsklinikum Ulm
  • フランス
      • Amiens、フランス、80054
        • CHU Amiens Picardie
      • Clermont-Ferrand、フランス、63000
        • CHU de Clermont Ferrand
      • Lille、フランス、59000
        • CHRU de Lille Hopital Claude Huriez
      • Marseille、フランス、13915
        • Aphm - Hopital Nord
      • Nantes、フランス、44000
        • CHU de Nantes hotel Dieu
      • Paris、フランス、75018
        • APHP - Hopital Bichat - Claude Bernard
  • ブラジル
      • Macaé、ブラジル、27910-020
        • Cliged
      • Passo Fundo、ブラジル、99010-120
        • Instituto Mederi de Pesquisa e Saude
      • Porto Alegre、ブラジル、90430001
        • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
      • Votuporanga、ブラジル、15501-405
        • INTEGRAL Pesquisa e Ensino
  • ベルギー
      • Ghent、ベルギー、9000
        • AZ Maria Middelares
      • Liège、ベルギー、4000
        • CHU de Liege
      • Sint-Niklaas、ベルギー
        • Vitaz
  • ポーランド
      • Bydgoszcz、ポーランド、85 231
        • NZOZ Centrum Medyczne KERmed
      • Rzeszów、ポーランド、35-326
        • Centrum Medyczne Medyk
      • Torun、ポーランド、87 100
        • GASTROMED Sp. z o.o.
      • Warsaw、ポーランド、00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Wroclaw、ポーランド、52-416
        • Centrum Medyczne Oporow
      • Wroclaw、ポーランド、54 144
        • EuroMediCare Szpital Specjalistyczny z Przychodnia
      • Wroclaw、ポーランド、50 449
        • Melita Medical Sp. z o.o.
      • Zamość、ポーランド、22-400
        • ETG Zamosc
  • 台湾
      • Changhua、台湾、500
        • Chang-Hua Christian Hospital
      • New Taipei City、台湾、22060
        • Far Eastern Memorial Hospital
      • Taipei、台湾、10002
        • National Taiwan University Hospital
      • Taipei、台湾、11217
        • Taipei Veterans General Hospital

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年歳以上 (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:

  • Has luminal Crohn's disease (CD) of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
  • Has clinically active CD, defined as a baseline CD activity index (CDAI) score greater than or equal to (>=)220 but <=450 and either: a. Mean daily stool frequency (SF) count >=4, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >=2, based on the unweighted CDAI component of abdominal pain (AP)
  • Active transmural activity in at least one segment (segmental magnetic resonance index of activity [MaRIA] >= 11)
  • a. Has demonstrated inadequate response/intolerance to conventional therapy; b. Has previously demonstrated lack of initial response (that is, primary non-responders), responded initially but then lost response with continued therapy (that is, secondary non-responders), or was intolerant to a maximum of 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (that is, janus kinase [JAK] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents)

Exclusion Criteria:

  • Has complications of Crohn's disease, such as symptomatic strictures or stenoses (unless less than [<]3 centimeter (cm) dilatation and not symptomatic or displaying associated fistula/fistulae and/or or abscess), fibrotic stenosis, internal fistulas, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab
  • Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participants with active perianal fistulas may be included if there are no associated stenoses, no anticipated surgery and no abscesses currently identified
  • Has had any kind of bowel resection within 6 months, or any other intra-abdominal or other major surgery within 12 weeks before baseline
  • Has a draining (that is, functioning) stoma or ostomy
  • Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, in the previous 4 months, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen

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：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Guselkumab

Participants will receive guselkumab 200 milligram (mg) intravenously (IV) at week 0, 4 and 8. Afterwards, participants will be alternately assigned at study level to 2 dose cohorts, high dose (200 mg subcutaneous (SC) every 4 weeks (Q4W) starting at week 12) through week 92 or low dose (100 mg SC every 8 weeks (Q8W) starting at week 16) through week 88. Starting at Week 24, participants in the low-dose cohort will be permitted to escalate to the 200 mg SC Q4W regimen if they are symptomatic and at the discretion of the investigator.
薬：Guselkumab

Guselkumab will be administered IV and SC.

他の名前：
  • CNTO1959;トレムフィア

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
Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments at Week 48
時間枠：At Week 48

Percentage of participants achieving a MaRIA <11 in all intestinal segments at Week 48 will be reported. The MaRIA scoring system is used to grade severity in Crohn's Disease (CD) by assessing ileocolonic CD activity on contrast-enhanced magnetic resonance imaging (MRI) enterography. Active disease is defined as a MaRIA score greater than or equal to (>=)7 whereas severe disease is defined as a MaRIA score >=11.
At Week 48

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Achieving a MaRIA <11 in All Intestinal Segments at Weeks 16 and 96.
時間枠：At Weeks 16 and 96

Percentage of participants achieving a MaRIA <11 in all intestinal segments at Weeks 16 and 96 will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic CD activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score >=7 whereas severe disease is defined as a MaRIA score >=11.
At Weeks 16 and 96
Percentage of Participants Achieving a MaRIA <11 and a Reduction of >=5 Points From Baseline in All Segments at Weeks 16, 48, and 96
時間枠：At Weeks 16, 48, and 96

Percentage of participants achieving a MaRIA <11 and a reduction of >=5 points from baseline in all segments at Weeks 16, 48, and 96 will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic Crohn disease activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score >=7 whereas severe disease is defined as a MaRIA score >=11.
At Weeks 16, 48, and 96
Percentage of Participants Achieving a MaRIA <11 in All Segments and Endoscopic Remission at Weeks 48 and 96
時間枠：At Week 48 and 96

Percentage of participants achieving a MaRIA <11 in all segments and endoscopic remission at Weeks 48 and 96 will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic CD activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score >=7 whereas severe disease is defined as a MaRIA score >=11. Endoscopic remission is defined as simple endoscopic score for Crohn's Disease (SES-CD) total score <=4 with at least 2 points reduction from baseline and no sub-score >1 in any individual component.
At Week 48 and 96
Percentage of Participants Achieving a MaRIA <11 in All Segments and Endoscopic Response at Weeks 48 and 96.
時間枠：At Weeks 48 and 96

Percentage of participants achieving a MaRIA <11 in all segments and endoscopic response at Weeks 48 and 96 will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic CD activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score >=7 whereas severe disease is defined as a MaRIA score >=11. Endoscopic Response is defined as >=50% improvement from baseline in simple endoscopic score for Crohn's Disease (SES-CD) total score or SES-CD total score <=2.
At Weeks 48 and 96
Percentage of Participants Achieving a MaRIA <11 in All Segments, Patient-Reported Outcome-2 (PRO-2) Remission, and No Worsening of Abdominal Pain (AP) or Stool Frequency (SF) From Baseline
時間枠：At Weeks 16, 48 and 96

Percentage of participants achieving a MaRIA <11 in all segments and PRO-2 remission and no worsening of abdominal pain (AP) or stool frequency (SF) from baseline will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic CD activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score greater than or equal to (>=)7 whereas severe disease is defined as a MaRIA score >=11. PRO-2 remission is defined as defined as AP mean daily score <=1 and a SF mean daily score <=3, and no worsening of AP or SF from baseline.
At Weeks 16, 48 and 96
Percentage of Participants Achieving a MaRIA <11 in All Segments and Biomarkers Remission
時間枠：At Weeks 16, 48 and 96

Percentage of participants achieving a MaRIA <11 in all segments and biomarkers remission will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic CD activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score >=7 whereas severe disease is defined as a MaRIA score >=11. Biomarker remission is defined as CRP <=3 mg/L and fecal calprotectin (fCal) <=250 mcg/g.
At Weeks 16, 48 and 96
Percentage of Participants Achieving a MaRIA <11 in All Segments, PRO-2, and Endoscopic Remission
時間枠：At Weeks 48 and 96

Percentage of participants achieving a MaRIA <11 in all segments, PRO-2, and endoscopic remission will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic CD activity on contrast-enhanced MRI enterography. The MaRIA scale is based on features that are predictors for active disease; bowel wall thickness, presence of mucosal ulcers, presence of mural edema, measurement of WSI before and after IV contrast administration and RCE of the intestinal wall. Active disease is defined as a MaRIA score greater than or equal to (>=)7 whereas severe disease is defined as a MaRIA score >=11. PRO is defined as defined as AP mean daily score <=1 and a SF ) mean daily score <=3, and no worsening of AP or SF from baseline. Endoscopic remission is defined as SES-CD total score <=4 with at least 2 points reduction from baseline and no sub-score >1 in any individual component.
At Weeks 48 and 96
Percentage of Participants Achieving a MaRIA <7 in All Intestinal Segments at Weeks 16, 48 and 96
時間枠：At Weeks 16, 48 and 96

Percentage of participants achieving a MaRIA <7 in all intestinal segments at Weeks 16, 48 and 96 will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic Crohn disease activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score >=7 whereas severe disease is defined as a MaRIA score >=11.
At Weeks 16, 48 and 96
Percentage of Participants Achieving a MaRIA <7 in All Segments and Endoscopic Remission at Weeks 48 and 96
時間枠：At Weeks 48 and 96

Percentage of participants achieving a MaRIA <7 in all segments and endoscopic remission at Weeks 48 and 96 will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic CD activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score greater than or equal to (>=)7 whereas severe disease is defined as a MaRIA score >=11. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic Crohn disease activity on contrast-enhanced MRI enterography. The MaRIA scale is based on features that are predictors for active disease; bowel wall thickness, presence of mucosal ulcers, presence of mural edema, measurement of WSI before and after IV contrast administration and RCE of the intestinal wall. Active disease is defined as a MaRIA score greater than or equal to (>=)7 whereas severe disease is defined as a MaRIA score >=11.
At Weeks 48 and 96
Absolute Value of Global Simple MaRIA Score Through Week 96
時間枠：Baseline up to Week 96

Absolute Value of global simple MaRIA score through Week 96 will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic Crohn disease activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score greater than or equal to (>=)7 whereas severe disease is defined as a MaRIA score >=11.
Baseline up to Week 96
Change From Baseline in the Global Simple MaRIA Score Through Week 96
時間枠：Up to Week 96

Change from baseline in the global simple MaRIA score through Week 96 will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic CD activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score >=7 whereas severe disease is defined as a MaRIA score >=11.
Up to Week 96
Percentage of Participants Achieving a MaRIA <7 in All Intestinal Segments and Not Receiving Corticosteroids at Weeks 16, 48, and 96
時間枠：At Weeks 16, 48, and 96

Percentage of participants achieving a MaRIA <7 in all intestinal segments and not receiving corticosteroids at Weeks 16, 48, and 96 will be reported. The MaRIA scoring system is used to grade severity in CD by assessing ileocolonic CD activity on contrast-enhanced MRI enterography. Active disease is defined as a MaRIA score >=7 whereas severe disease is defined as a MaRIA score >=11.
At Weeks 16, 48, and 96
Percentage of Participants Achieving Transmural Segmental Response with Intestinal Ultrasound (IUS) at Weeks 4, 8, 16, 48, and 96
時間枠：Baseline, at Weeks 4, 8, 16, 48, and 96

Percentage of participants achieving transmural segmental response with IUS at Weeks 4, 8, 16, 48, and 96 will be reported. Transmural segmental response with IUS is defined as a reduction from baseline of 25 percent (%) in BWT or a reduction from baseline of bowel wall thickness (BWT) >=2 mm or a reduction from baseline of BWT >=1 millimeter (mm) plus a decrease from baseline in color doppler signal (CDS) >=1 point.
Baseline, at Weeks 4, 8, 16, 48, and 96
Percentage of Participants with Transmural Response (total) at Weeks 4, 8, 16, 48, and Week 96
時間枠：Baseline, at Weeks 4, 8, 16, 48, and Week 96

Percentage of participants with transmural response (total) at Weeks 4, 8, 16, 48, and Week 96 will be reported. Transmural segmental response with IUS is defined as: a reduction from baseline of 25 percent (%) in BWT or a reduction from baseline of BWT >=2 millimeter (mm) or a reduction from baseline of BWT >=1 mm plus a decrease from baseline in color doppler >=1 point, per baseline pathological segment. Transmural response (total) requires that at least one pathological segment at baseline fulfills the criteria.
Baseline, at Weeks 4, 8, 16, 48, and Week 96
Percentage of Participants Achieving Transmural Remission with IUS at Weeks 4, 8, 16, 48, and 96
時間枠：At Weeks 4, 8, 16, 48, and 96

Percentage of participants achieving transmural remission with IUS at Weeks 4, 8, 16, 48, and 96 will be reported. Transmural remission with IUS is defined as BWT <=3 mm for ileum and colon plus color doppler signal 0, in all segments.
At Weeks 4, 8, 16, 48, and 96
Absolute Value of International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) Through Week 96
時間枠：Baseline up to Week 96

Absolute value of IBUS-SAS through Week 96 will be reported. IBUS-SAS score is defined as 4*BWT+15*IMF+7*CDS+4*BWS.
Baseline up to Week 96
Change from Baseline in International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) Through Week 96
時間枠：Up to Week 96

Change from baseline in IBUS-SAS through Week 96 will be reported. IBUS-SAS score is defined as 4*BWT+15*IMF+7*CDS+4*BWS.
Up to Week 96
Percentage of Participants Achieving IBUS-SAS Response at Weeks 4, 8, 16, 48, and Week 96
時間枠：Baseline, at Weeks 4, 8, 16, 48, and Week 96

Percentage of participants achieving IBUS-SAS response at Weeks 4, 8, 16, 48, and Week 96 will be reported. IBUS-SAS is defined as a reduction in IBUS-SAS score from baseline of >=10 points per baseline pathological segment and segmental score <=12 (if not pathological), at baseline.
Baseline, at Weeks 4, 8, 16, 48, and Week 96
Percentage of Participants Achieving BWT <=3 mm for Ileum and Colon Plus CDS 0, in all segments and Participants Not Receiving Corticosteroids at Weeks 4, 8, 16, 48, and 96
時間枠：At Weeks 4, 8, 16, 48, and 96

Percentage of participants achieving BWT <=3 mm for Ileum and Colon plus CDS 0, in all segments at Weeks 4, 8, 16, 48, and 96 will be reported. Participants not receiving corticosteroids achieving BWT <=3 mm for Ileum and Colon plus CDS 0 at Weeks 4, 8, 16, 48, and 96 will be reported.
At Weeks 4, 8, 16, 48, and 96
Absolute Value of BWT through Week 96
時間枠：Baseline up to Week 96

Absolute Value of BWT through Week 96 will be reported.
Baseline up to Week 96
Change From Baseline in BWT Through Week 96
時間枠：Up to Week 96

Change from baseline in BWT through Week 96 will be reported.
Up to Week 96
Absolute Value of Simple IUS Score For CD (SUS-CD) Score Through Week 96
時間枠：Baseline up to Week 96

Absolute value of SUS-CD score through Week 96 will be reported. SUS-CD is based on the sum of classifications for BWT and CDS for all segments.
Baseline up to Week 96
Change From Baseline in the SUS-CD Score Through Week 96
時間枠：Up to Week 96

Change from Baseline in the SUS-CD score through Week 96 will be reported. SUS-CD is based on the sum of classifications for BWT and CDS for all segments.
Up to Week 96
Percentage of Participants Achieving Endoscopic Response at Weeks 48 and 96
時間枠：Weeks 48 and 96

Percentage of participants with transmural response (total) at Weeks 48 and Week 96 will be reported. Endoscopic Response is defined as >=50% improvement from baseline in SES-CD total score or SES-CD <=2.
Weeks 48 and 96
Percentage of Participants Achieving Endoscopic Remission at Weeks 48 and 96
時間枠：At Weeks 48 and 96

Percentage of participants achieving endoscopic remission at Weeks 48 and 96 will be reported. Endoscopic remission is defined as SES-CD total score <=4 with at least 2 points reduction from baseline and no sub-score >1 in any individual component.
At Weeks 48 and 96
Absolute Value of SES-CD Total Score Through Week 96
時間枠：Baseline up to Week 96

Absolute value of SES-CD total score through Week 96 will be reported. The SES-CD score is used to evaluate endoscopic improvement. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 56.
Baseline up to Week 96
Change From Baseline in the SES-CD Total Score Through Week 96
時間枠：Up to Week 96

Change from baseline in the SES-CD total score through Week 96 will be reported. The SES-CD score is used to evaluate Endoscopic Improvement. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 56.
Up to Week 96
Percentage of Participants (Not Receiving Corticosteroids) Achieving Endoscopic Remission at Weeks 48 and 96
時間枠：Baseline, at Weeks 48 and 96

Percentage of participants (not receiving corticosteroids) achieving endoscopic remission at Weeks 48 and 96 will be reported. Endoscopic remission is defined as SES-CD total score <=4 with at least 2 points reduction from baseline and no sub-score >1 in any individual component.
Baseline, at Weeks 48 and 96
Percentage of Participants Achieving Endoscopic Healing of the Intestinal Mucosa at Weeks 48 and 96
時間枠：At Weeks 48 and 96

Percentage of participants achieving endoscopic healing of the intestinal mucosa at Weeks 48 and 96 will be reported. Endoscopic healing is defined as the resolution (absence) of mucosal ulcers in response to a therapeutic intervention.
At Weeks 48 and 96
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) <150 at Weeks 4, 8, 16, 48 and 96
時間枠：At Weeks 4, 8, 16, 48 and 96

Percentage of participants achieving CDAI <150 at Weeks 4, 8, 16, 48 and 96 will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on daily basis.
At Weeks 4, 8, 16, 48 and 96
Percentage of Participants Achieving a Reduction in the CDAI Score of >=100 points or CDAI <150 From Baseline at Weeks 4, 8, 16, 48, and 96
時間枠：At Weeks 4, 8, 16, 48, and 96

Percentage of participants achieving a reduction in the CDAI score of >=100 points or CDAI <150 from Baseline at Weeks 4, 8, 16, 48, and 96 will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on daily basis.
At Weeks 4, 8, 16, 48, and 96
Percentage of Participants (Not Receiving Corticosteroids) Achieving CDAI Score <150 at Weeks 4, 8, 16, 48 and 96
時間枠：At Weeks 4, 8, 16, 48 and 96

Percentage of participants (not receiving corticosteroids) achieving CDAI Score <150 at Weeks 4, 8, 16, 48 and 96 will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on daily basis.
At Weeks 4, 8, 16, 48 and 96
Absolute Value of CDAI Score Through Week 96
時間枠：Baseline up to Week 96

Absolute Value of CDAI score through Week 96 will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on daily basis.
Baseline up to Week 96
Change From Baseline in CDAI Score Through Week 96
時間枠：Up to Week 96

Change from baseline in CDAI score through Week 96 will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on daily basis.
Up to Week 96
Percentage of Participants Achieving PRO-2 Remission at Weeks 4, 8, 16, 48, and Week 96
時間枠：At Weeks 4, 8, 16, 48, and Week 96

Percentage of participants achieving PRO-2 remission at Weeks 4, 8, 16, 48, and Week 96 will be reported. PRO-2 remission is defined as AP mean daily score <=1 and a SF mean daily score <=3, and no worsening of AP or SF from baseline.
At Weeks 4, 8, 16, 48, and Week 96
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Weeks 48 and 96
時間枠：At Week 48 and Week 96

Percentage of participants achieving IBDQ remission at Weeks 48 and 96 will be reported. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate PROs across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).
At Week 48 and Week 96
Percentage of Participants Achieving IBDQ Response at Weeks 48 and 96
時間枠：Baseline, at Weeks 48 and 96

Percentage of participants achieving IBDQ response at Weeks 48 and 96 will be reported. IBDQ response is defined as >=16-point improvement in IBDQ score from baseline. IBDQ score ranges from 32 to 224, with higher scores indicating better outcomes.
Baseline, at Weeks 48 and 96
Absolute Value of IBDQ Through Week 96
時間枠：Baseline up to Week 96

Absolute value of IBDQ through Week 96 will be reported. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate PROs across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Baseline up to Week 96
Change From Baseline in IBDQ Score Through Week 96
時間枠：Up to Week 96

Change from baseline in IBDQ score through Week 96 will be reported. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate PROs across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Up to Week 96
Change from Baseline in Urgency Numeric Rating Scale (UNRS) Through Week 96
時間枠：Baseline up to Week 96

Change from baseline in UNRS through Week 96 will be reported. UNRS is designed to assess changes in the severity of bowel urgency (sudden or immediate need). Severity of bowel urgency is defined by the patient's perception of overall experience in which respondents consider the immediacy of bowel movement urgency severity over 24 h on an 11-point horizontal NRS ranging from 0 ('no urgency') to 10 ('worst possible urgency').
Baseline up to Week 96
Percentage of Participants Achieving C-reactive Protein (CRP) Normalization at Weeks 4, 8, 16, 48, and Week 96
時間枠：Baseline, at Weeks 4, 8, 16, 48, and Week 96

CRP normalization is defined as CRP <=3 mg/L, among participants with baseline elevation in CRP (that is, >3 mg/L).
Baseline, at Weeks 4, 8, 16, 48, and Week 96
Percentage of Participants Achieving >=50% Improvement of CRP Response From Baseline at Weeks 4, 8, 16, 48, and 96
時間枠：Baseline, at Weeks 4, 8, 16, 48, and 96

Percentage of participants achieving >=50% improvement of CRP response from baseline at Weeks 4, 8, 16, 48, and 96 will be reported.
Baseline, at Weeks 4, 8, 16, 48, and 96
Percentage of Participants Achieving fCal Normalization at Weeks 4, 8, 16, 48, and 96
時間枠：Baseline, at Weeks 4, 8, 16, 48, and 96

Percentage of participants achieving fCal normalization at Weeks 4, 8, 16, 48, and 96 will be reported. fCal normalization is defined as fCal <=250 mcg/g among participants with elevated fCal at baseline.
Baseline, at Weeks 4, 8, 16, 48, and 96
Percentage of Participants Achieving >=50% Improvement of fCal Response From Baseline at Weeks 4, 8, 16, 48, and 96
時間枠：Baseline, at Weeks 4, 8, 16, 48, and 96

Percentage of participants achieving >=50% improvement of fCal response from baseline at Weeks 4, 8, 16, 48, and 96 will be reported.
Baseline, at Weeks 4, 8, 16, 48, and 96
Change From Baseline in CRP and fCal Levels Over Time
時間枠：Baseline, Weeks 4, 8, 16, 32, 48, and 96

Change from baseline in CRP and fCal levels over time will be reported.
Baseline, Weeks 4, 8, 16, 32, 48, and 96
Values of CRP and fCal Levels Over Time
時間枠：Baseline, Weeks 4, 8, 16, 32, 48, and 96

Values of CRP and fCal levels over time will be reported.
Baseline, Weeks 4, 8, 16, 32, 48, and 96
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TSAEs) Through Week 48
時間枠：Up to Week 48

An AE is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as the AEs occurring after first administration of study intervention (or worsened since then). An serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TESAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state.
Up to Week 48

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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。

スポンサー

Janssen-Cilag Ltd.

捜査官

  • スタディディレクター：Janssen Cilag Ltd. Clinical trial、Janssen-Cilag Ltd.

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)

2024年4月17日

一次修了 (推定)

2027年6月8日

研究の完了 (推定)

2028年3月6日

試験登録日

最初に提出

2024年5月7日

QC基準を満たした最初の提出物

2024年5月7日

最初の投稿 (実際)

2024年5月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11月1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

  • CNTO1959CRD3008
  • CNTO1959CRD3008 (その他の識別子：Janssen Research & Development, LLC)
  • 2023-504040-34-00 (レジストリ識別子：EUCT number)
  • 2023 (米国 NIH グラント/契約)

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

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

はい

米国FDA規制機器製品の研究

いいえ

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