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Transmurální hojení a účinek guselkumabu na modifikaci onemocnění u pacientů s Crohnovou chorobou (REASON)

2. listopadu 2026 aktualizováno: Janssen-Cilag Ltd.

Fáze 3b, jednoramenná, otevřená, multicentrická studie k hodnocení transmurálního hojení a efektu guselkumabu modifikujícího onemocnění u pacientů s Crohnovou chorobou

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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

120

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: Guselkumab

Guselkumab will be administered IV and SC.

Ostatní jména:
  • CNTO1959; TREMFYA

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments at Week 48
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Achieving a MaRIA <11 in All Intestinal Segments at Weeks 16 and 96.
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Janssen-Cilag Ltd.

Vyšetřovatelé

  • Ředitel studie: Janssen Cilag Ltd. Clinical trial, Janssen-Cilag Ltd.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. dubna 2024

Primární dokončení (Odhadovaný)

8. června 2027

Dokončení studie (Odhadovaný)

6. března 2028

Termíny zápisu do studia

První předloženo

7. května 2024

První předloženo, které splnilo kritéria kontroly kvality

7. května 2024

První zveřejněno (Aktuální)

10. května 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CNTO1959CRD3008
  • CNTO1959CRD3008 (Jiný identifikátor: Janssen Research & Development, LLC)
  • 2023-504040-34-00 (Identifikátor registru: EUCT number)
  • 2023 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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