A Study of Guselkumab Subcutaneous Therapy in Participant... | NCT05197049

NCT05197049

ID	Type	Description
CNTO1959CRD3004	Other Identifier	Janssen Research & Development, LLC
2020-006165-11	EudraCT Number
2023-504737-41-00	Registry Identifier	EUCT number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Guselkumab	Experimental	Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.	Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2
Group 2: Guselkumab	Experimental	Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.	Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 3
Group 3: Placebo	Placebo Comparator	Participants will receive placebo injection subcutaneously.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Guselkumab Dose 1	Drug	Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.	Group 1: Guselkumab Group 2: Guselkumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved Clinical Remission 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 activity) and a decrease in total CDAI score over time indicates improvement in disease activity.	At Week 12
Percentage of Participants Who Achieved Endoscopic Response 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 for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.	At Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved Clinical Remission 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 CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.

Eligibility Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Health Specialists of the Southeast		Dothan	Alabama	36305	United States
Advanced Gastro P.C

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40113101	Derived	Hart A, Panaccione R, Steinwurz F, Danese S, Hisamatsu T, Cao Q, Ritter T, Seidler U, Olurinde M, Vetter ML, Yee J, Yang Z, Wang Y, Johanns J, Han C, Sahoo A, Terry NA, Sands BE, D'Haens G; GRAVITI Study Group. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study. Gastroenterology. 2025 Aug;169(2):308-325. doi: 10.1053/j.gastro.2025.02.033. Epub 2025 Mar 18.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg SC injection on Weeks 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 28 through Week 48.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 4, 2024	Jan 16, 2025

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (CDAI score >220 and <70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50% increase in SES-CD from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.
BG001	Guselkumab 400 mg + 100 mg	Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8, followed by guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48 and a placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48. Participants who met at least one of the rescue criteria (CDAI score >220 and <70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50% increase in SES-CD from baseline at Week 12) at Week 16 received rescue treatment (sham): continued receiving guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48, along with placebo matched to guselkumab 400 mg SC injection on Weeks 16, 20 and 24, and placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 28 through Week 48.
BG002	Guselkumab 400 mg + 200 mg	Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8, followed by guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48, and a placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (CDAI score >220 and <70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50% increase in SES-CD from baseline at Week 12) at Week 16 received rescue treatment: (sham): continued receiving guselkumab 200 mg SC injection every 4 weeks from Week 16 through Week 48, along with placebo matched to guselkumab 200 mg SC injection on Weeks 16, 20 and 24 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00050 BG00149 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0009 BG00110 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

BELGIUM

Title	Measurements
	BG0001 BG0010 BG002

AgeContinuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00036± 12.71 BG00137.4± 13.32 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Achieved Clinical Remission 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 activity) and a decrease in total CDAI score over time indicates improvement in disease activity.

Full analysis set (FAS) included all randomized participants who received at least 1 dose of study intervention. As prespecified in Statistical Analysis Plan (SAP), for this outcome measure (OM), combined data for both guselkumab treatment groups were collected and analyzed because they received the same regimen of guselkumab 400 mg SC at Weeks 0, 4, and 8.

Posted

Number

95% Confidence Interval

Percentage of participants

At Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.
OG001	Combined: Guselkumab 400 mg	Participants of arm "Guselkumab 400 mg + 100 mg" and "Guselkumab 400 mg + 200 mg" received guselkumab 400 mg SC injections at Week 0, 4, and 8.

Units	Counts
Participants	OG000117 OG001230

Title

Denominators

Categories

Title	Measurements
	OG00021.4(13.9 to 28.8) OG00156.1(49.7 to 62.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mantel Haenszel	Mantel-Haenszel stratum weights and the Sato variance estimator.	< 0.001		Adjusted treatment difference:percentage	34.9			2-Sided	95	25.1	44.6					Superiority

Primary

Percentage of Participants Who Achieved Endoscopic Response 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 for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.

Posted

Number

95% Confidence Interval

Percentage of participants

At Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.

Secondary

Percentage of Participants Who Achieved Clinical Remission 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 CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.

Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study intervention.

Posted

Number

95% Confidence Interval

Percentage of participants

At Week 24

ID	Title	Description
OG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.

Secondary

Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission 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 by the total number of days assessments were performed. Mean daily SF and AP scores at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease.

Posted

Number

95% Confidence Interval

Percentage of participants

At Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.

Secondary

Percentage of Participants Who Achieved Clinical Response 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 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.

Posted

Number

95% Confidence Interval

Percentage of participants

At Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.

Secondary

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through 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.

Safety analysis set included all randomized participants who received at least 1 dose of study intervention.

Posted

Number

Percentage of participants

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

ID	Title	Description
OG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.

Secondary

Percentage of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 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 of Week 48 was considered treatment-emergent.

Safety analysis set included all randomized participants who received at least 1 dose of study intervention.

Posted

Number

Percentage of participants

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

ID	Title	Description
OG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.

Secondary

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation of Study Drug Through 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.

Safety analysis set included all randomized participants who received at least 1 dose of study intervention.

Posted

Number

Percentage of participants

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

ID	Title	Description
OG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo matched to guselkumab 400 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, and 8 followed by placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (Crohn's Disease Activity Index [CDAI] score greater than [>] 220 and less than [<] 70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50 percent [%] increase in Simple Endoscopic Score for Crohn's Disease [SES-CD] from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48.	0	117	16	117	57	117
EG001	Placebo Arm Subset (Rescue Treatment): Placebo to Guselkumab	Participants randomized to placebo arm who met at least one of the rescue criteria (CDAI score >220 and <70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50% increase in SES-CD from baseline at Week 12) at Week 16 received rescue treatment: guselkumab 400 mg SC injection at Weeks 16, 20, and 24 along with placebo matched to guselkumab 100 mg on Week 16 and 24 followed by guselkumab 100 mg SC injection every 8 weeks from Week 32 through Week 48 and placebo matched to guselkumab 200 mg every 4 weeks from Week 28 through Week 48. For this arm, data were collected and analyzed after the participants of arm "Placebo" crossed over to receive rescue treatment with guselkumab.	0	44	1	44	19	44
EG002	Guselkumab 400 mg + 100 mg	Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8, followed by guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48 and a placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48. Participants who met at least one of the rescue criteria (CDAI score >220 and <70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50% increase in SES-CD from baseline at Week 12) at Week 16 received rescue treatment (sham): continued receiving guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48, along with placebo matched to guselkumab 400 mg SC injection on Weeks 16, 20 and 24, and placebo matched to guselkumab 200 mg SC injection every 4 weeks from Week 28 through Week 48.	1	115	15	115	65	115
EG003	Guselkumab 400 mg + 200 mg	Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8, followed by guselkumab 200 mg SC injection every 4 weeks from Week 12 through Week 48, and a placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48. Participants who met at least one of the rescue criteria (CDAI score >220 and <70-point reduction from baseline CDAI score at both Weeks 12 and 16 or at least 50% increase in SES-CD from baseline at Week 12) at Week 16 received rescue treatment: (sham): continued receiving guselkumab 200 mg SC injection every 4 weeks from Week 16 through Week 48, along with placebo matched to guselkumab 200 mg SC injection on Weeks 16, 20 and 24 and placebo matched to guselkumab 100 mg SC injection every 8 weeks from Week 16 through Week 48.	0	115	9	115	68	115

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG0030 affected115 at risk
Angina Pectoris	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Ventricular Tachycardia	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Thyroid Cyst	Endocrine disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Keratitis	Eye disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Anal Fistula	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Crohn's Disease	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0007 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0022 affected115 at risk EG003
Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Intestinal Perforation	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Large Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Pyrexia	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Portal Vein Thrombosis	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Anal Abscess	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0011 affected44 at risk EG0020 affected115 at risk EG003
Appendicitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Forearm Fracture	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Gastrointestinal Anastomotic Stenosis	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Gun Shot Wound	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Procedural Intestinal Perforation	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Intervertebral Disc Disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Intraductal Papilloma of Breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Vertebrobasilar Insufficiency	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Breast Hyperplasia	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Cervical Dysplasia	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Ovarian Cyst	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected117 at risk EG0010 affected44 at risk EG0028 affected115 at risk EG0032 affected115 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0007 affected117 at risk EG0013 affected44 at risk EG00210 affected115 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0024 affected115 at risk EG003
Crohn's Disease	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG00017 affected117 at risk EG0013 affected44 at risk EG0028 affected115 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected117 at risk EG0010 affected44 at risk EG0026 affected115 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0004 affected117 at risk EG0010 affected44 at risk EG0021 affected115 at risk EG003
Fatigue	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0023 affected115 at risk EG003
Pyrexia	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0008 affected117 at risk EG0012 affected44 at risk EG0023 affected115 at risk EG003
Covid-19	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0008 affected117 at risk EG0011 affected44 at risk EG00211 affected115 at risk EG003
Folliculitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0012 affected44 at risk EG0024 affected115 at risk EG003
Influenza	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0005 affected117 at risk EG0011 affected44 at risk EG0026 affected115 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0006 affected117 at risk EG0013 affected44 at risk EG0028 affected115 at risk EG003
Tonsillitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0025 affected115 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG00012 affected117 at risk EG0018 affected44 at risk EG00215 affected115 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0004 affected117 at risk EG0011 affected44 at risk EG0022 affected115 at risk EG003
White Blood Cell Count Decreased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0004 affected117 at risk EG0010 affected44 at risk EG0026 affected115 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected117 at risk EG0012 affected44 at risk EG0021 affected115 at risk EG003
Headache	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0005 affected117 at risk EG0011 affected44 at risk EG0027 affected115 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected117 at risk EG0010 affected44 at risk EG0020 affected115 at risk EG003

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases