Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06408935




Registration number
NCT06408935
Ethics application status
Date submitted
7/05/2024
Date registered
10/05/2024
Date last updated
22/06/2025

Titles & IDs
Public title
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
Scientific title
A Phase 3b, Open-label, Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients
Secondary ID [1] 0 0
CNTO1959CRD3008
Secondary ID [2] 0 0
CNTO1959CRD3008
Universal Trial Number (UTN)
Trial acronym
REASON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab

Experimental: 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.


Treatment: Drugs: Guselkumab
Guselkumab will be administered IV and SC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments at Week 48
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
At Week 48
Secondary outcome [1] 0 0
Percentage of Participants Achieving a MaRIA <11 in All Intestinal Segments at Weeks 16 and 96.
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
At Weeks 16 and 96
Secondary outcome [2] 0 0
Percentage of Participants Achieving a MaRIA <11 and a Reduction of >=5 Points From Baseline in All Segments at Weeks 16, 48, and 96
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
At Weeks 16, 48, and 96
Secondary outcome [3] 0 0
Percentage of Participants Achieving a MaRIA <11 in All Segments and Endoscopic Remission at Weeks 48 and 96
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
At Week 48 and 96
Secondary outcome [4] 0 0
Percentage of Participants Achieving a MaRIA <11 in All Segments and Endoscopic Response at Weeks 48 and 96.
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
At Weeks 48 and 96
Secondary outcome [5] 0 0
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
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
At Weeks 16, 48 and 96
Secondary outcome [6] 0 0
Percentage of Participants Achieving a MaRIA <11 in All Segments and Biomarkers Remission
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
At Weeks 16, 48 and 96
Secondary outcome [7] 0 0
Percentage of Participants Achieving a MaRIA <11 in All Segments, PRO-2, and Endoscopic Remission
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
At Weeks 48 and 96
Secondary outcome [8] 0 0
Percentage of Participants Achieving a MaRIA <7 in All Intestinal Segments at Weeks 16, 48 and 96
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
At Weeks 16, 48 and 96
Secondary outcome [9] 0 0
Percentage of Participants Achieving a MaRIA <7 in All Segments and Endoscopic Remission at Weeks 48 and 96
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
At Weeks 48 and 96
Secondary outcome [10] 0 0
Absolute Value of Global Simple MaRIA Score Through Week 96
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
Baseline up to Week 96
Secondary outcome [11] 0 0
Change From Baseline in the Global Simple MaRIA Score Through Week 96
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
Up to Week 96
Secondary outcome [12] 0 0
Percentage of Participants Achieving a MaRIA <7 in All Intestinal Segments and Not Receiving Corticosteroids at Weeks 16, 48, and 96
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
At Weeks 16, 48, and 96
Secondary outcome [13] 0 0
Percentage of Participants Achieving Transmural Segmental Response with Intestinal Ultrasound (IUS) at Weeks 4, 8, 16, 48, and 96
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Baseline, at Weeks 4, 8, 16, 48, and 96
Secondary outcome [14] 0 0
Percentage of Participants with Transmural Response (total) at Weeks 4, 8, 16, 48, and Week 96
Assessment method [14] 0 0
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.
Timepoint [14] 0 0
Baseline, at Weeks 4, 8, 16, 48, and Week 96
Secondary outcome [15] 0 0
Percentage of Participants Achieving Transmural Remission with IUS at Weeks 4, 8, 16, 48, and 96
Assessment method [15] 0 0
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.
Timepoint [15] 0 0
At Weeks 4, 8, 16, 48, and 96
Secondary outcome [16] 0 0
Absolute Value of International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) Through Week 96
Assessment method [16] 0 0
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.
Timepoint [16] 0 0
Baseline up to Week 96
Secondary outcome [17] 0 0
Change from Baseline in International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) Through Week 96
Assessment method [17] 0 0
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.
Timepoint [17] 0 0
Up to Week 96
Secondary outcome [18] 0 0
Percentage of Participants Achieving IBUS-SAS Response at Weeks 4, 8, 16, 48, and Week 96
Assessment method [18] 0 0
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.
Timepoint [18] 0 0
Baseline, at Weeks 4, 8, 16, 48, and Week 96
Secondary outcome [19] 0 0
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
Assessment method [19] 0 0
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.
Timepoint [19] 0 0
At Weeks 4, 8, 16, 48, and 96
Secondary outcome [20] 0 0
Absolute Value of BWT through Week 96
Assessment method [20] 0 0
Absolute Value of BWT through Week 96 will be reported.
Timepoint [20] 0 0
Baseline up to Week 96
Secondary outcome [21] 0 0
Change From Baseline in BWT Through Week 96
Assessment method [21] 0 0
Change from baseline in BWT through Week 96 will be reported.
Timepoint [21] 0 0
Up to Week 96
Secondary outcome [22] 0 0
Absolute Value of Simple IUS Score For CD (SUS-CD) Score Through Week 96
Assessment method [22] 0 0
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.
Timepoint [22] 0 0
Baseline up to Week 96
Secondary outcome [23] 0 0
Change From Baseline in the SUS-CD Score Through Week 96
Assessment method [23] 0 0
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.
Timepoint [23] 0 0
Up to Week 96
Secondary outcome [24] 0 0
Percentage of Participants Achieving Endoscopic Response at Weeks 48 and 96
Assessment method [24] 0 0
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.
Timepoint [24] 0 0
Weeks 48 and 96
Secondary outcome [25] 0 0
Percentage of Participants Achieving Endoscopic Remission at Weeks 48 and 96
Assessment method [25] 0 0
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.
Timepoint [25] 0 0
At Weeks 48 and 96
Secondary outcome [26] 0 0
Absolute Value of SES-CD Total Score Through Week 96
Assessment method [26] 0 0
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.
Timepoint [26] 0 0
Baseline up to Week 96
Secondary outcome [27] 0 0
Change From Baseline in the SES-CD Total Score Through Week 96
Assessment method [27] 0 0
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.
Timepoint [27] 0 0
Up to Week 96
Secondary outcome [28] 0 0
Percentage of Participants (Not Receiving Corticosteroids) Achieving Endoscopic Remission at Weeks 48 and 96
Assessment method [28] 0 0
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.
Timepoint [28] 0 0
Baseline, at Weeks 48 and 96
Secondary outcome [29] 0 0
Percentage of Participants Achieving Endoscopic Healing of the Intestinal Mucosa at Weeks 48 and 96
Assessment method [29] 0 0
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.
Timepoint [29] 0 0
At Weeks 48 and 96
Secondary outcome [30] 0 0
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) <150 at Weeks 4, 8, 16, 48 and 96
Assessment method [30] 0 0
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.
Timepoint [30] 0 0
At Weeks 4, 8, 16, 48 and 96
Secondary outcome [31] 0 0
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
Assessment method [31] 0 0
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.
Timepoint [31] 0 0
At Weeks 4, 8, 16, 48, and 96
Secondary outcome [32] 0 0
Percentage of Participants (Not Receiving Corticosteroids) Achieving CDAI Score <150 at Weeks 4, 8, 16, 48 and 96
Assessment method [32] 0 0
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.
Timepoint [32] 0 0
At Weeks 4, 8, 16, 48 and 96
Secondary outcome [33] 0 0
Absolute Value of CDAI Score Through Week 96
Assessment method [33] 0 0
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.
Timepoint [33] 0 0
Baseline up to Week 96
Secondary outcome [34] 0 0
Change From Baseline in CDAI Score Through Week 96
Assessment method [34] 0 0
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.
Timepoint [34] 0 0
Up to Week 96
Secondary outcome [35] 0 0
Percentage of Participants Achieving PRO-2 Remission at Weeks 4, 8, 16, 48, and Week 96
Assessment method [35] 0 0
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.
Timepoint [35] 0 0
At Weeks 4, 8, 16, 48, and Week 96
Secondary outcome [36] 0 0
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Weeks 48 and 96
Assessment method [36] 0 0
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).
Timepoint [36] 0 0
At Week 48 and Week 96
Secondary outcome [37] 0 0
Percentage of Participants Achieving IBDQ Response at Weeks 48 and 96
Assessment method [37] 0 0
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.
Timepoint [37] 0 0
Baseline, at Weeks 48 and 96
Secondary outcome [38] 0 0
Absolute Value of IBDQ Through Week 96
Assessment method [38] 0 0
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.
Timepoint [38] 0 0
Baseline up to Week 96
Secondary outcome [39] 0 0
Change From Baseline in IBDQ Score Through Week 96
Assessment method [39] 0 0
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.
Timepoint [39] 0 0
Up to Week 96
Secondary outcome [40] 0 0
Change from Baseline in Urgency Numeric Rating Scale (UNRS) Through Week 96
Assessment method [40] 0 0
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').
Timepoint [40] 0 0
Baseline up to Week 96
Secondary outcome [41] 0 0
Percentage of Participants Achieving C-reactive Protein (CRP) Normalization at Weeks 4, 8, 16, 48, and Week 96
Assessment method [41] 0 0
CRP normalization is defined as CRP \<=3 mg/L, among participants with baseline elevation in CRP (that is, \>3 mg/L).
Timepoint [41] 0 0
Baseline, at Weeks 4, 8, 16, 48, and Week 96
Secondary outcome [42] 0 0
Percentage of Participants Achieving >=50% Improvement of CRP Response From Baseline at Weeks 4, 8, 16, 48, and 96
Assessment method [42] 0 0
Percentage of participants achieving \>=50% improvement of CRP response from baseline at Weeks 4, 8, 16, 48, and 96 will be reported.
Timepoint [42] 0 0
Baseline, at Weeks 4, 8, 16, 48, and 96
Secondary outcome [43] 0 0
Percentage of Participants Achieving fCal Normalization at Weeks 4, 8, 16, 48, and 96
Assessment method [43] 0 0
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.
Timepoint [43] 0 0
Baseline, at Weeks 4, 8, 16, 48, and 96
Secondary outcome [44] 0 0
Percentage of Participants Achieving >=50% Improvement of fCal Response From Baseline at Weeks 4, 8, 16, 48, and 96
Assessment method [44] 0 0
Percentage of participants achieving \>=50% improvement of fCal response from baseline at Weeks 4, 8, 16, 48, and 96 will be reported.
Timepoint [44] 0 0
Baseline, at Weeks 4, 8, 16, 48, and 96
Secondary outcome [45] 0 0
Change From Baseline in CRP and fCal Levels Over Time
Assessment method [45] 0 0
Change from baseline in CRP and fCal levels over time will be reported.
Timepoint [45] 0 0
Baseline, Weeks 4, 8, 16, 32, 48, and 96
Secondary outcome [46] 0 0
Values of CRP and fCal Levels Over Time
Assessment method [46] 0 0
Values of CRP and fCal levels over time will be reported.
Timepoint [46] 0 0
Baseline, Weeks 4, 8, 16, 32, 48, and 96
Secondary outcome [47] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TSAEs) Through Week 48
Assessment method [47] 0 0
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.
Timepoint [47] 0 0
Up to Week 48

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/07/2029
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Northern Hospital - Melbourne
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
3076 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Macae
Country [2] 0 0
Brazil
State/province [2] 0 0
Passo Fundo
Country [3] 0 0
Brazil
State/province [3] 0 0
Porto Alegre
Country [4] 0 0
Brazil
State/province [4] 0 0
Votuporanga
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Czechia
State/province [8] 0 0
Ceske Budejovice
Country [9] 0 0
Czechia
State/province [9] 0 0
Hradec Kralove
Country [10] 0 0
Czechia
State/province [10] 0 0
Praha 9
Country [11] 0 0
Germany
State/province [11] 0 0
Augsburg
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Dachau
Country [14] 0 0
Germany
State/province [14] 0 0
Frankfurt
Country [15] 0 0
Germany
State/province [15] 0 0
Gottingen
Country [16] 0 0
Germany
State/province [16] 0 0
Halle
Country [17] 0 0
Germany
State/province [17] 0 0
Hannover
Country [18] 0 0
Germany
State/province [18] 0 0
Kiel
Country [19] 0 0
Germany
State/province [19] 0 0
Lüneburg
Country [20] 0 0
Germany
State/province [20] 0 0
Münster
Country [21] 0 0
Germany
State/province [21] 0 0
Pforzheim
Country [22] 0 0
Germany
State/province [22] 0 0
Ulm
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
Holon
Country [25] 0 0
Israel
State/province [25] 0 0
Jerusalem
Country [26] 0 0
Israel
State/province [26] 0 0
Nahariya
Country [27] 0 0
Israel
State/province [27] 0 0
Petah Tikva
Country [28] 0 0
Israel
State/province [28] 0 0
Ramat Gan
Country [29] 0 0
Israel
State/province [29] 0 0
Tel Aviv
Country [30] 0 0
Italy
State/province [30] 0 0
Bologna
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Rho
Country [33] 0 0
Italy
State/province [33] 0 0
Roma
Country [34] 0 0
Italy
State/province [34] 0 0
Rozzano
Country [35] 0 0
Italy
State/province [35] 0 0
San Giovanni Rotondo
Country [36] 0 0
Poland
State/province [36] 0 0
Bydgoszcz
Country [37] 0 0
Poland
State/province [37] 0 0
Rzeszow
Country [38] 0 0
Poland
State/province [38] 0 0
Torun
Country [39] 0 0
Poland
State/province [39] 0 0
Warszawa
Country [40] 0 0
Poland
State/province [40] 0 0
Wroclaw
Country [41] 0 0
Poland
State/province [41] 0 0
Zamosc
Country [42] 0 0
Slovakia
State/province [42] 0 0
Banska Bystrica
Country [43] 0 0
Slovakia
State/province [43] 0 0
Bratislava
Country [44] 0 0
Slovakia
State/province [44] 0 0
Nitra
Country [45] 0 0
Slovakia
State/province [45] 0 0
Presov
Country [46] 0 0
Spain
State/province [46] 0 0
Alicante
Country [47] 0 0
Spain
State/province [47] 0 0
Cordoba
Country [48] 0 0
Spain
State/province [48] 0 0
Ferrol
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Valencia
Country [51] 0 0
Spain
State/province [51] 0 0
Vigo
Country [52] 0 0
Taiwan
State/province [52] 0 0
Changhua
Country [53] 0 0
Taiwan
State/province [53] 0 0
New Taipei
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen-Cilag Ltd.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Cilag Ltd. Clinical trial
Address 0 0
Janssen-Cilag Ltd.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Email 0 0
Participate-In-This-Study1@its.jnj.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06408935