이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

크론병 환자에서 구셀쿠맙의 경벽 치유 및 질병 개선 효과 (REASON)

2026년 11월 2일 업데이트: Janssen-Cilag Ltd.

크론병 환자에서 구셀쿠맙의 경벽 치유 및 질병 완화 효과를 평가하기 위한 제3b상, 단일군, 공개 라벨, 다기관 연구

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

120

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Guselkumab

Guselkumab will be administered IV and SC.

다른 이름들:
  • CNTO1959; 트렘피아

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments at Week 48
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Achieving a MaRIA <11 in All Intestinal Segments at Weeks 16 and 96.
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Janssen-Cilag Ltd.

수사관

  • 연구 책임자: Janssen Cilag Ltd. Clinical trial, Janssen-Cilag Ltd.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 4월 17일

기본 완료 (추정된)

2027년 6월 8일

연구 완료 (추정된)

2028년 3월 6일

연구 등록 날짜

최초 제출

2024년 5월 7일

QC 기준을 충족하는 최초 제출

2024년 5월 7일

처음 게시됨 (실제)

2024년 5월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CNTO1959CRD3008
  • CNTO1959CRD3008 (기타 식별자: Janssen Research & Development, LLC)
  • 2023-504040-34-00 (레지스트리 식별자: EUCT number)
  • 2023 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다