此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease (DUET ENCORE-CD)

2026年8月27日 更新者：Janssen Research & Development, LLC

A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive [worsens with time] and life-threatening disease of the intestine).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

460

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Beijing、中国、100191
        • 招聘中
        • Peking University Third Hospital
      • Changzhou、中国、213004
        • 招聘中
        • Changzhou No 2 Peoples Hospital
      • Chongqing、中国、400014
        • 招聘中
        • Chongqing General Hospital
      • Guangzhou、中国、510655
        • 招聘中
        • Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
      • Hangzhou、中国、310000
        • 招聘中
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Huai'an、中国、223300
        • 招聘中
        • Huai'an 1st Hospital
      • Ningbo、中国、315041
        • 招聘中
        • Ningbo Medical Center Lihuili Hospital
      • Zhuzhou、中国、412007
        • 招聘中
        • Zhuzhou Central Hospital
  • 以色列
      • Ashdod、以色列、7747629
        • 招聘中
        • Assuta Medical Center
      • Haifa、以色列、3109601
        • 招聘中
        • Rambam Medical Center
      • Haifa、以色列、31048
        • 招聘中
        • Bnai Zion Medical Center
      • Holon、以色列、5822012
        • 招聘中
        • Wolfson Medical Center
      • Jerusalem、以色列、9103102
        • 招聘中
        • Shaare Zedek Medical Center
      • Kfar Saba、以色列、44281
        • 招聘中
        • Meir Medical Center
      • Nahariya、以色列、2210001
        • 招聘中
        • Galilee Medical Center
      • Petah Tikva、以色列、4941492
        • 招聘中
        • Rabin Medical Center
      • Ramat Gan、以色列、52621
        • 招聘中
        • Sheba medical center
      • Tel Aviv、以色列、64239
        • 招聘中
        • Tel Aviv Sourasky Medical Center
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T5R 1W2
        • 招聘中
        • Gastroenterology and Internal Medicine Research Institute (GIRI)
      • Edmonton、Alberta、加拿大、Code: T6K 4B2
        • 招聘中
        • South Edmonton Gastroenterology Research Clinic
    • British Columbia
      • Vancouver、British Columbia、加拿大、V6Z 2K5
        • 招聘中
        • GI Research Institute (G.I.R.I.)
    • Nova Scotia
      • Kentville、Nova Scotia、加拿大、B4N 0A3
        • 招聘中
        • Viable Clinical Research
    • Ontario
      • London、Ontario、加拿大、N6K 1M6
        • 招聘中
        • London Digestive Disease Institute
      • Mississauga、Ontario、加拿大、L5M 2S4
        • 招聘中
        • West GTA Research Inc
      • Toronto、Ontario、加拿大、M6A 3B4
        • 招聘中
        • Toronto Immune and Digestive Health Institute Inc
    • Quebec
      • Montreal、Quebec、加拿大、H2X 0C1
        • 招聘中
        • CHUM - Centre hospitalier universitaire de Montreal
      • Montreal、Quebec、加拿大、H3H1E3
        • 招聘中
        • Clinique IMD
  • 印度
      • Hubballi、印度、580021
        • 招聘中
        • Sushruta Multispecialty Hospital and Research Centre
      • Hyderabad、印度、500032
        • 招聘中
        • Asian Institute of Gastroenterology
      • Jaipur、印度、302006
        • 招聘中
        • S. R. Kalla Memorial General Hospital
      • Kochi、印度、682018
        • 招聘中
        • Lisie Hospital
      • Secunderabad、印度、500003
        • 招聘中
        • Yashoda Super Speciality Hospitals
      • Surat、印度、395002
        • 招聘中
        • SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
      • Surat、印度、395009
        • 招聘中
        • Gujarat Gastro and Vascular Hospital
  • 台湾
      • Taoyuan、台湾、333
        • 招聘中
        • Linkou Chang Gung Memorial Hospital
  • 土耳其（türkiye）
      • Antalya、土耳其（türkiye）、07100
        • 招聘中
        • Antalya Training and Research Hospital
      • Istanbul、土耳其（türkiye）、34899
        • 招聘中
        • Marmara University Pendik Training Hospital
      • Istanbul、土耳其（türkiye）、34093
        • 招聘中
        • Bezmialem University Medical Faculty
      • Izmir、土耳其（türkiye）、35540
        • 招聘中
        • Izmir Şehir Hastanesi
      • Kocaeli、土耳其（türkiye）、41001
        • 招聘中
        • Kocaeli University Medical Faculty
      • Mersin、土耳其（türkiye）、33343
        • 招聘中
        • Mersin University Medical Faculty
  • 巴西
      • Curitiba、巴西、80430 180
        • 招聘中
        • CDC - Centro Digestivo de Curitiba
      • Macaé、巴西、27910-020
        • 招聘中
        • Cliged
      • Porto Alegre、巴西、90035 903
        • 招聘中
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre、巴西、90160 093
        • 招聘中
        • Hospital Ernesto Dornelles
      • Santo André、巴西、09080-110
        • 招聘中
        • Pesquisare Saúde
      • São Paulo、巴西、01236 030
        • 招聘中
        • BR Trials
      • São Paulo、巴西、04077-020
        • 招聘中
        • Rocco And Nazato Servicos Medicos Ltda
      • Votuporanga、巴西、15500-269
        • 招聘中
        • Integral Pesquisa e Ensino
  • 德国
      • Berlin、德国、14163
        • 招聘中
        • Krankenhaus Waldfriede Mitte
      • Dresden、德国、01307
        • 招聘中
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Hanover、德国、30625
        • 招聘中
        • Medizinische Hochschule Hannover
      • Kiel、德国、24105
        • 招聘中
        • Universitatsklinikum Schleswig Holstein Kiel
      • Leipzig、德国、04103
        • 招聘中
        • EUGASTRO GmbH
      • Mannheim、德国、68167
        • 招聘中
        • Universitaetsklinikum Mannheim
      • Rostock、德国、18057
        • 招聘中
        • Universitaetsmedizin Rostock
  • 挪威
      • Tromsø、挪威、9038
        • 招聘中
        • Universitetssykehuset Nord-Norge HF
      • Trondheim、挪威、7030
        • 招聘中
        • St. Olavs Hospital
      • Ålesund、挪威、6017
        • 招聘中
        • Alesund sjukehus
  • 捷克语
      • Hradec Králové、捷克语、500 12
        • 招聘中
        • Hepato-gastroenterologie HK, s.r.o.
      • Prague、捷克语、190 00
        • 招聘中
        • ISCARE a.s.
      • Prague、捷克语、14000
        • 招聘中
        • Fakultni Thomayerova nemocnice
  • 斯洛伐克
      • Banská Bystrica、斯洛伐克、975 17
        • 招聘中
        • FNsP F. D. Roosevelta Banska Bystrica
      • Bratislava、斯洛伐克、811 09
        • 招聘中
        • Cliniq s.r.o.
      • Košice、斯洛伐克、040 13
        • 招聘中
        • ENDOMED s.r.o
      • Nitra、斯洛伐克、949 01
        • 招聘中
        • KM Management spol. s r.o.
      • Prešov、斯洛伐克、080 01
        • 招聘中
        • GASTRO I. s.r.o.
      • Prešov、斯洛伐克、080 01
        • 招聘中
        • Gastro LM s.r.o.
  • 日本
      • Hamamatsu、日本、431-3192
        • 招聘中
        • Hamamatsu University Hospital
      • Hirosaki、日本、036-8545
        • 招聘中
        • National Hospital Organization Hirosaki National Hospital
      • Kagoshima、日本、892-0843
        • 招聘中
        • Kagoshima IBD Gastroenterology Clinic
      • Kashiwa、日本、277-0871
        • 招聘中
        • Tsujinaka Hospital Kashiwanoha
      • Kobe、日本、650 0017
        • 招聘中
        • Kobe University Hospital
      • Kumamoto、日本、860-8556
        • 招聘中
        • Kumamoto University Hospital
      • Kumamoto、日本、861-8520
        • 招聘中
        • Japanese Red Cross Kumamoto Hospital
      • Kumamoto、日本、862-0971
        • 招聘中
        • Takano Hospital
      • Minatoku、日本、108-8642
        • 招聘中
        • Kitasato University Kitasato Institute Hospital
      • Nagoya、日本、467-8602
        • 招聘中
        • Nagoya City University Hospital
      • Osaka、日本、540-0006
        • 招聘中
        • National Hospital Organization Osaka National Hospital
      • Osaka、日本、543-8555
        • 招聘中
        • Japanese Red Cross Osaka Hospital
      • Sapporo、日本、065-0033
        • 招聘中
        • Sapporo Higashi Tokushukai Hospital
      • Sapporo、日本、060-0033
        • 招聘中
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
      • Shimizu、日本、411-8611
        • 招聘中
        • National Hospital Organization Shizuoka Medical Center
      • Takamatsu、日本、760-0017
        • 招聘中
        • Takamatsu Red Cross Hospital
      • Yamanashi、日本、400-8506
        • 招聘中
        • Yamanashi Prefectural Central Hospital
  • 比利时
      • Edegem、比利时、2650
        • 招聘中
        • Universitair Ziekenhuis Antwerpen
      • Ghent、比利时、9000
        • 招聘中
        • Ghent University Hospital
      • Leuven、比利时、3000
        • 招聘中
        • Universitair Ziekenhuis Leuven
      • Roeselare、比利时、8800
        • 招聘中
        • Algemeen Ziekenhuis Delta
  • 法国
      • Nantes、法国、44000
        • 招聘中
        • CHU de Nantes hotel Dieu
      • Reims、法国、51100
        • 招聘中
        • CHU de Reims
  • 波兰
      • Bydgoszcz、波兰、85 229
        • 招聘中
        • Centrum Medyczne Medis ManerMed Sp Z O O
      • Krakow、波兰、31-513
        • 招聘中
        • Centrum Medyczne PROMED
      • Lublin、波兰、20 582
        • 招聘中
        • Medrise Sp. z o.o.
      • Rzeszów、波兰、35-055
        • 招聘中
        • Centrum Medyczne 'Medyk' Sp. z o.o. K.
      • Szczecin、波兰、71-434
        • 招聘中
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Zamość、波兰、22 400
        • 招聘中
        • ETG Zamość
  • 澳大利亚
      • Adelaide、澳大利亚、5000
        • 招聘中
        • Banksia Trials SA
      • Camperdown、澳大利亚、2050
        • 招聘中
        • Royal Prince Alfred Hospital
      • Clayton、澳大利亚、3168
        • 招聘中
        • Monash Medical Centre
      • East Melbourne、澳大利亚、3002
        • 招聘中
        • The Melbourne Gut Clinic Epworth Hospital
      • Kurralta Park、澳大利亚、5037
        • 招聘中
        • IBD SA
      • New Lambton Heights、澳大利亚、2305
        • 招聘中
        • John Hunter Hospital
      • South Brisbane、澳大利亚、4101
        • 招聘中
        • Mater Misericordiae Hospital
  • 美国
    • California
      • Anaheim、California、美国、92805
        • 招聘中
        • Clinnova Research
      • Chula Vista、California、美国、91910
        • 招聘中
        • Gastro SB Clinic
      • Los Alamitos、California、美国、90720
        • 招聘中
        • United Medical Doctors
      • San Diego、California、美国、92123
        • 招聘中
        • Medical Associates Research Group, Inc.
    • Colorado
      • Colorado Springs、Colorado、美国、80907
        • 招聘中
        • Peak Gastroenterology Associates
    • Florida
      • Lakewood Rch、Florida、美国、34211
        • 招聘中
        • Florida Research Center Inc.
      • Miami、Florida、美国、33157-6575
        • 招聘中
        • Sanchez Clinical Research, Inc
      • Tampa、Florida、美国、33609
        • 招聘中
        • GCP Clinical Research
    • Georgia
      • Suwanee、Georgia、美国、30024
        • 招聘中
        • Atlanta Gastroenterology Specialists
    • Kentucky
      • Crestview Hills、Kentucky、美国、41017
        • 招聘中
        • Tri-State Gastroenterology Assoc
    • Louisiana
      • Lafayette、Louisiana、美国、70503
        • 招聘中
        • Gastroenterology Clinic of Acadiana
    • Michigan
      • Farmington Hills、Michigan、美国、48334
        • 招聘中
        • Michigan Center of Medical Research
    • New York
      • New York、New York、美国、10075
        • 招聘中
        • New York Gastroenterology Associates
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • 招聘中
        • University of North Carolina Hospital
    • Ohio
      • Mentor、Ohio、美国、44060
        • 招聘中
        • Great Lakes Gastroenterology Research, LLC
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73114
        • 招聘中
        • Digestive Disease Specialists Inc
    • Oregon
      • Portland、Oregon、美国、97220
        • 招聘中
        • The Oregon Clinic
    • Tennessee
      • Cordova、Tennessee、美国、38018
        • 招聘中
        • Gastro One
    • Texas
      • Tyler、Texas、美国、75701
        • 招聘中
        • Tyler Research Institute, LLC
    • Washington
      • Tacoma、Washington、美国、98405
        • 招聘中
        • GI Alliance Tacoma
  • 荷兰
      • Nijmegen、荷兰、6525 GA
        • 招聘中
        • Radboud Umcn
  • 葡萄牙
      • Braga、葡萄牙、4710 243
        • 招聘中
        • Uls Braga - Hosp. Braga
      • Viana do Castelo、葡萄牙、4900-408
        • 招聘中
        • Ulsam - Hosp. Santa Luzia
  • 西班牙
      • Madrid、西班牙、28031
        • 招聘中
        • Hosp. Univ. Infanta Leonor
      • Vigo、西班牙、36312
        • 招聘中
        • Hosp. Alvaro Cunqueiro
  • 阿根廷
      • AAI、阿根廷、C1425BGC
        • 招聘中
        • GEDYT
      • La Plata、阿根廷、1896
        • 招聘中
        • Globalpsy
      • Mendoza、阿根廷、M5500DPS
        • 招聘中
        • HIGEA
      • Quilmes、阿根廷、B1878DVB
        • 招聘中
        • Cer Instituto Medico
  • 韩国
      • Busan、韩国、48108
        • 招聘中
        • Inje University Haeundae Paik Hospital
      • Daejeon、韩国、34943
        • 招聘中
        • The Catholic University of Korea Daejeon St Mary's Hospital
      • Gangnam Gu、韩国、06351
        • 招聘中
        • Samsung Medical Center
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center
  • 马来西亚
      • Ampang、马来西亚、68000
        • 招聘中
        • Hospital Ampang
      • Kajang、马来西亚、43000
        • 招聘中
        • Sultan Idris Shah Hospital
      • Kota Kinabalu、马来西亚、88586
        • 招聘中
        • Hospital Queen Elizabeth
      • Kuala、马来西亚、20400
        • 招聘中
        • Hospital Sultanah Nur Zahirah
      • Petaling Jaya、马来西亚、50603
        • 招聘中
        • University Malaya Medical Centre

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion criteria:

  • Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
  • Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >= 2.0, based on the unweighted CDAI component of abdominal pain (AP)
  • Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
  • Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies

Exclusion criteria:

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC
  • Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study
  • Presence of draining (that is, functioning) stoma or ostomy
  • Has a history of short bowel syndrome, is missing greater than (>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention
  • Currently has or is suspected of having an abscess

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：JNJ-78934804
Participants will receive JNJ-78934804 induction dose, at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
药品：JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
其他名称：
  • JNJ-4804
有源比较器：Guselkumab
Participants will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.
药品：古塞库单抗
Guselkumab 将皮下给药。
其他名称：
  • TREMFYA
药品：JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
其他名称：
  • JNJ-4804

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Co-Primary: Percentage of Participants with Clinical Remission at Week 48
大体时间：At Week 48
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Week 48
Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48
大体时间：At Week 48
Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (>) 1 in any individual component. 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 lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
At Week 48

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants with Deep Remission at Week 48
大体时间：At Week 48
Deep remission (composite endpoint) is defined as achieving both clinical remission and endoscopic remission at Week 48 at the participant level. Clinical remission is defined as a CDAI score of <150 and Endoscopic remission is defined as a SES-CD score of <= 4 with at least a 2-point reduction from baseline and no subscore >1 in any individual component. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
At Week 48
Percentage of Participants with Corticosteroid-Free (90-Day) Clinical Remission at Week 48
大体时间：At Week 48
Corticosteroid-free (90-day) clinical remission at Week 48 is defined as clinical remission at Week 48 and not receiving corticosteroids for at least 90 days prior to Week 48. Clinical remission is defined as a CDAI score of <150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Week 48
Percentage of Participants with Corticosteroid-Free (90-day) PRO-2 Remission at Week 48
大体时间：At Week 48
Corticosteroid-free (90-day) patient-reported outcome(s) (PRO-2) remission at Week 48 is defined as an abdominal plan (AP) mean daily score less than or equal to (<=) 1 and stool frequency (SF) mean daily score <= 2.8, and no worsening of AP or SF from baseline, and not receiving corticosteroids for at least 90 days prior to Week 48.
At Week 48
Percentage of Participants with Sustained Clinical Remission
大体时间：At Weeks 12 and 48
Sustained clinical remission is defined as clinical remission at Week 12 and Week 48. Clinical remission is defined as CDAI score of <150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Weeks 12 and 48
Percentage of Participants with Histologic-Endoscopic Remission at Week 48
大体时间：At Week 48
Histologic-endoscopic remission at week 48 is defined as achieving a combination of histologic remission and endoscopic remission at Week 48. Histologic remission is defined as absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, or ulcerations or granulation tissue as assessed by the Robarts Histopathology Index. Endoscopic remission is defined as a SES-CD score of <= 4 with at least a 2-point reduction from baseline and no subscore > 1 in any individual component.
At Week 48
Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48
大体时间：At Week 48
IBDQ response at Week 48 is defined as an improvement of at least 16 points in the IBDQ total score from baseline at Week 48. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate disease-specific health related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, AP), systemic function (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.
At Week 48
Percentage of Participants with Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Mental Component Summary Score (MCS) Response at Week 48
大体时间：At Week 48
PROMIS-29 MCS response at Week 48 is defined as an improvement of at least 7 points in PROMIS-29 MCS score from baseline at Week 48. The PROMIS-29 is a collection of short forms containing 4 items for each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities). PROMIS-29 also includes an overall average pain intensity 0-10 numeric rating scale. The PROMIS-29 MCS will be assessed, which is primarily informed by domains of emotional distress (depression/anxiety) and fatigue as well as sleep disturbance where higher MCS scores reflect better mental health.
At Week 48
Percentage of Participants with Clinical Remission at Week 12
大体时间：At Week 12
Clinical remission at Week 12 is defined as CDAI score <150 at Week 12. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Week 12
Percentage of Participants with Endoscopic Response at Week 12
大体时间：At Week 12
Endoscopic response at Week 12 is defined as greater than (>) 50 percent (%) improvement from baseline in SES-CD score at Week 12 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
At Week 12
Number of Participants with Adverse Events (AE) and Serious AEs (SAEs)
大体时间：Up to approximately 3 years
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. An 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, and is medically important.
Up to approximately 3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Janssen Research & Development, LLC

调查人员

  • 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月22日

初级完成 (估计的)

2028年6月12日

研究完成 (估计的)

2030年7月12日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月11日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 78934804CRD3001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅