18 and older, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Achieved Clinical Remission at Week 12Primary· At Week 12
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activi
Group
Value
95% CI
Placebo
21.4
13.9 – 28.8
Combined: Guselkumab 400 mg
56.1
49.7 – 62.5
Percentage of Participants Who Achieved Endoscopic Response at Week 12Primary· At Week 12
Percentage of participants who achieved endoscopic response at Week 12 were reported. Endoscopic response was defined as greater than or equal to (\>=) 50 percent (%) improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, and presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, and rectum), each scored from 0 (best) to 3 (worst) for each segment except narrowing component
Group
Value
95% CI
Placebo
21.4
13.9 – 28.8
Combined: Guselkumab 400 mg
41.3
34.9 – 47.7
Percentage of Participants Who Achieved Clinical Remission at Week 24Secondary· At Week 24
Percentage of participants who achieved clinical remission at Week 24 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total C
Group
Value
95% CI
Placebo
21.4
13.9 – 28.8
Guselkumab 400 mg + 100 mg
60.9
51.9 – 69.8
Guselkumab 400 mg + 200 mg
58.3
49.2 – 67.3
Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission at Week 12Secondary· At Week 12
Percentage of participants who achieved PRO-2 remission at Week 12 were reported. PRO-2 remission was defined as an abdominal pain (AP) mean daily score \<=1, and stool frequency (SF) mean daily score \<=3, and no worsening of AP or SF from baseline. Mean daily AP score based on the CDAI was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score based on the CDAI was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided b
Group
Value
95% CI
Placebo
17.1
10.3 – 23.9
Combined: Guselkumab 400 mg
49.1
42.7 – 55.6
Percentage of Participants Who Achieved Clinical Response at Week 12Secondary· At Week 12
Clinical response was defined as a decrease from baseline in CDAI score \>= 100 points or CDAI score \< 150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 60
Group
Value
95% CI
Placebo
33.3
24.8 – 41.9
Combined: Guselkumab 400 mg
73.5
67.8 – 79.2
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 48Secondary· Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
Percentage of participants with TEAEs through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent.
Group
Value
95% CI
Placebo
65.8
Guselkumab 400 mg + 100 mg
82.6
Guselkumab 400 mg + 200 mg
80.0
Placebo Arm Subset (Rescue Treatment): Placebo to Guselkumab
75.0
Percentage of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 48Secondary· Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
Percentage of participants with TESAEs through Week 48 were reported. An SAE was any untoward medical occurrence in a clinical study participant resulting in any of the following outcomes or was deemed significant for any other reason: death, life-threatening (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. An AE does not necessarily have a causal relationship with the study drug. Any SAE that occurred at or after the initial administration of study drug (Week 0) through the data cutoff
Group
Value
95% CI
Placebo
13.7
Guselkumab 400 mg + 100 mg
13.0
Guselkumab 400 mg + 200 mg
7.8
Placebo Arm Subset (Rescue Treatment): Placebo to Guselkumab
2.3
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation of Study Drug Through Week 48Secondary· Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
Percentage of participants with TEAEs leading to discontinuation of study drug through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent.
Group
Value
95% CI
Placebo
8.5
Guselkumab 400 mg + 100 mg
3.5
Guselkumab 400 mg + 200 mg
2.6
Placebo Arm Subset (Rescue Treatment): Placebo to Guselkumab
2.3
Adverse events — posted to ClinicalTrials.gov
Time frame: For arms Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 16/117 (14%)
Deaths: 0/117
Placebo Arm Subset (Rescue Treatment): Placebo to Guselkumab
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05197049.