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Transmural helande och sjukdomsmodifierande effekt av Guselkumab hos patienter med Crohns sjukdom (REASON)

2 november 2026 uppdaterad av: Janssen-Cilag Ltd.

En fas 3b, enarmad, öppen, multicenterstudie för att utvärdera transmural läkning och sjukdomsmodifierande effekt av Guselkumab hos patienter med Crohns sjukdom

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

120

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Guselkumab

Guselkumab will be administered IV and SC.

Andra namn:
  • CNTO1959; TREMFYA

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving a MaRIA <11 in All Intestinal Segments at Weeks 16 and 96.
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Janssen-Cilag Ltd.

Utredare

  • Studierektor: Janssen Cilag Ltd. Clinical trial, Janssen-Cilag Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 april 2024

Primärt slutförande (Beräknad)

8 juni 2027

Avslutad studie (Beräknad)

6 mars 2028

Studieregistreringsdatum

Först inskickad

7 maj 2024

Först inskickad som uppfyllde QC-kriterierna

7 maj 2024

Första postat (Faktisk)

10 maj 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CNTO1959CRD3008
  • CNTO1959CRD3008 (Annan identifierare: Janssen Research & Development, LLC)
  • 2023-504040-34-00 (Registeridentifierare: EUCT number)
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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