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

27 agosto 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

460

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Altri nomi:
  • JNJ-4804
Comparatore attivo: 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.
Droga: Guselkumab
Guselkumab verrà somministrato per via sottocutanea.
Altri nomi:
  • TREMFYA
Droga: JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Altri nomi:
  • JNJ-4804

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Co-Primary: Percentage of Participants with Clinical Remission at Week 48
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants with Deep Remission at Week 48
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 maggio 2026

Completamento primario (Stimato)

12 giugno 2028

Completamento dello studio (Stimato)

12 luglio 2030

Date di iscrizione allo studio

Primo inviato

5 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 78934804CRD3001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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