A Phase 3 interventional study of Guselkumab in Crohn's Disease, sponsored by Janssen-Cilag Ltd.. Active, not recruiting at 84 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Janssen-Cilag Ltd. · Phase 3, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 120 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Janssen-Cilag Ltd. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Guselkumab
Guselkumab will be administered IV and SC.
Also known as: CNTO1959; TREMFYA
Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments 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.
Time frame: At Week 48
Percentage of Participants Achieving a MaRIA <11 in All Intestinal Segments 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.
Time frame: 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
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.
Time frame: At Weeks 16, 48, and 96
Percentage of Participants Achieving a MaRIA <11 in All Segments and Endoscopic Remission at Weeks 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.
Time frame: At Week 48 and 96
Percentage of Participants Achieving a MaRIA <11 in All Segments and Endoscopic Response 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.
Time frame: 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
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.
Time frame: At Weeks 16, 48 and 96
Percentage of Participants Achieving a MaRIA <11 in All Segments and Biomarkers Remission
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.
Time frame: At Weeks 16, 48 and 96
Percentage of Participants Achieving a MaRIA <11 in All Segments, PRO-2, and Endoscopic Remission
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.
Time frame: At Weeks 48 and 96
Percentage of Participants Achieving a MaRIA <7 in All Intestinal Segments 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.
Time frame: At Weeks 16, 48 and 96
Percentage of Participants Achieving a MaRIA <7 in All Segments and Endoscopic Remission 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.
Time frame: At Weeks 48 and 96
Absolute Value of Global Simple MaRIA Score Through 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.
Time frame: Baseline up to Week 96
Change From Baseline in the Global Simple MaRIA Score Through 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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: At Weeks 4, 8, 16, 48, and 96
Absolute Value of International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) Through 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.
Time frame: Baseline up to Week 96
Change from Baseline in International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) Through 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.
Time frame: Up to Week 96
Percentage of Participants Achieving IBUS-SAS Response 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.
Time frame: 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
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.
Time frame: At Weeks 4, 8, 16, 48, and 96
Absolute Value of BWT through Week 96
Absolute Value of BWT through Week 96 will be reported.
Time frame: Baseline up to Week 96
Change From Baseline in BWT Through Week 96
Change from baseline in BWT through Week 96 will be reported.
Time frame: Up to Week 96
Absolute Value of Simple IUS Score For CD (SUS-CD) Score Through 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.
Time frame: Baseline up to Week 96
Change From Baseline in the SUS-CD Score Through 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.
Time frame: Up to Week 96
Percentage of Participants Achieving Endoscopic Response at 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.
Time frame: Weeks 48 and 96
Percentage of Participants Achieving Endoscopic Remission 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.
Time frame: At Weeks 48 and 96
Absolute Value of SES-CD Total Score Through 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.
Time frame: Baseline up to Week 96
Change From Baseline in the SES-CD Total Score Through 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.
Time frame: Up to Week 96
Percentage of Participants (Not Receiving Corticosteroids) Achieving Endoscopic Remission 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.
Time frame: Baseline, at Weeks 48 and 96
Percentage of Participants Achieving Endoscopic Healing of the Intestinal Mucosa 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.
Time frame: At Weeks 48 and 96
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) <150 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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: At Weeks 4, 8, 16, 48 and 96
Absolute Value of CDAI Score Through 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.
Time frame: Baseline up to Week 96
Change From Baseline in CDAI Score Through 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.
Time frame: Up to Week 96
Percentage of Participants Achieving PRO-2 Remission 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.
Time frame: At Weeks 4, 8, 16, 48, and Week 96
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Weeks 48 and 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).
Time frame: At Week 48 and Week 96
Percentage of Participants Achieving IBDQ Response 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.
Time frame: Baseline, at Weeks 48 and 96
Absolute Value of IBDQ Through 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.
Time frame: Baseline up to Week 96
Change From Baseline in IBDQ Score Through 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.
Time frame: Up to Week 96
Change from Baseline in Urgency Numeric Rating Scale (UNRS) Through 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').
Time frame: Baseline up to Week 96
Percentage of Participants Achieving C-reactive Protein (CRP) Normalization 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).
Time frame: 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
Percentage of participants achieving \>=50% improvement of CRP response from baseline at Weeks 4, 8, 16, 48, and 96 will be reported.
Time frame: Baseline, at Weeks 4, 8, 16, 48, and 96
Percentage of Participants Achieving fCal Normalization 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.
Time frame: 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
Percentage of participants achieving \>=50% improvement of fCal response from baseline at Weeks 4, 8, 16, 48, and 96 will be reported.
Time frame: Baseline, at Weeks 4, 8, 16, 48, and 96
Change From Baseline in CRP and fCal Levels Over Time
Change from baseline in CRP and fCal levels over time will be reported.
Time frame: Baseline, Weeks 4, 8, 16, 32, 48, and 96
Values of CRP and fCal Levels Over Time
Values of CRP and fCal levels over time will be reported.
Time frame: 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
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.
Time frame: Up to Week 48
Plan to share: Yes — 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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen-Cilag Ltd.