Trial Outcomes & Findings for A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT05528510)

Last Updated: 2026-02-05

Results Overview

Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

418 participants

Primary outcome timeframe

Week 12

Results posted on

2026-02-05

Participant Flow

Results are currently reported up to the primary completion date (02-Apr-2024). Results of remaining duration will be posted upon study completion.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Guselkumab 400 mg q4w - Guselkumab 100 mg q8w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 100 mg SC injection every 8 weeks (q8w) starting from Week 16 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Overall Study STARTED	139	139	140
Overall Study Participants Who Started Rescue Medication	52	27	23
Overall Study COMPLETED	131	136	136
Overall Study NOT COMPLETED	8	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Guselkumab 400 mg q4w - Guselkumab 100 mg q8w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 100 mg SC injection every 8 weeks (q8w) starting from Week 16 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Overall Study Death	1	0	0
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	4	1	3
Overall Study Other	2	2	1

Baseline Characteristics

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Guselkumab 400 mg q4w - Guselkumab 100 mg q8w n=139 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 100 mg SC injection every 8 weeks (q8w) starting from Week 16 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w n=140 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.	Total n=418 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 13.58 • n=25 Participants	42.1 years STANDARD_DEVIATION 14.59 • n=26 Participants	43.6 years STANDARD_DEVIATION 14.27 • n=51 Participants	41.7 years STANDARD_DEVIATION 14.22 • n=27 Participants
Sex: Female, Male Female	49 Participants n=25 Participants	60 Participants n=26 Participants	53 Participants n=51 Participants	162 Participants n=27 Participants
Sex: Female, Male Male	90 Participants n=25 Participants	79 Participants n=26 Participants	87 Participants n=51 Participants	256 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=25 Participants	30 Participants n=26 Participants	26 Participants n=51 Participants	79 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	112 Participants n=25 Participants	102 Participants n=26 Participants	112 Participants n=51 Participants	326 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=25 Participants	7 Participants n=26 Participants	2 Participants n=51 Participants	13 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	4 Participants n=26 Participants	0 Participants n=51 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Asian	40 Participants n=25 Participants	41 Participants n=26 Participants	40 Participants n=51 Participants	121 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=25 Participants	6 Participants n=26 Participants	6 Participants n=51 Participants	13 Participants n=27 Participants
Race (NIH/OMB) White	94 Participants n=25 Participants	85 Participants n=26 Participants	91 Participants n=51 Participants	270 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=25 Participants	1 Participants n=26 Participants	1 Participants n=51 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=25 Participants	2 Participants n=26 Participants	2 Participants n=51 Participants	7 Participants n=27 Participants
AgeCategorical Adults (18-64 years)	131 Participants n=25 Participants	123 Participants n=26 Participants	131 Participants n=51 Participants	385 Participants n=27 Participants
AgeCategorical 65 years and over	8 Participants n=25 Participants	16 Participants n=26 Participants	9 Participants n=51 Participants	33 Participants n=27 Participants
Region of Enrollment ARGENTINA	4 Participants n=25 Participants	4 Participants n=26 Participants	3 Participants n=51 Participants	11 Participants n=27 Participants
Region of Enrollment AUSTRALIA	2 Participants n=25 Participants	2 Participants n=26 Participants	3 Participants n=51 Participants	7 Participants n=27 Participants
Region of Enrollment BELGIUM	0 Participants n=25 Participants	2 Participants n=26 Participants	0 Participants n=51 Participants	2 Participants n=27 Participants
Region of Enrollment BRAZIL	17 Participants n=25 Participants	18 Participants n=26 Participants	19 Participants n=51 Participants	54 Participants n=27 Participants
Region of Enrollment BULGARIA	1 Participants n=25 Participants	2 Participants n=26 Participants	1 Participants n=51 Participants	4 Participants n=27 Participants
Region of Enrollment CANADA	1 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	1 Participants n=27 Participants
Region of Enrollment CHINA	19 Participants n=25 Participants	12 Participants n=26 Participants	16 Participants n=51 Participants	47 Participants n=27 Participants
Region of Enrollment CZECH REPUBLIC	4 Participants n=25 Participants	5 Participants n=26 Participants	3 Participants n=51 Participants	12 Participants n=27 Participants
Region of Enrollment FRANCE	3 Participants n=25 Participants	6 Participants n=26 Participants	3 Participants n=51 Participants	12 Participants n=27 Participants
Region of Enrollment GERMANY	2 Participants n=25 Participants	1 Participants n=26 Participants	2 Participants n=51 Participants	5 Participants n=27 Participants
Region of Enrollment HUNGARY	3 Participants n=25 Participants	1 Participants n=26 Participants	4 Participants n=51 Participants	8 Participants n=27 Participants
Region of Enrollment INDIA	3 Participants n=25 Participants	2 Participants n=26 Participants	8 Participants n=51 Participants	13 Participants n=27 Participants
Region of Enrollment ISRAEL	2 Participants n=25 Participants	2 Participants n=26 Participants	2 Participants n=51 Participants	6 Participants n=27 Participants
Region of Enrollment JAPAN	7 Participants n=25 Participants	15 Participants n=26 Participants	10 Participants n=51 Participants	32 Participants n=27 Participants
Region of Enrollment JORDAN	9 Participants n=25 Participants	6 Participants n=26 Participants	6 Participants n=51 Participants	21 Participants n=27 Participants
Region of Enrollment MALAYSIA	2 Participants n=25 Participants	3 Participants n=26 Participants	2 Participants n=51 Participants	7 Participants n=27 Participants
Region of Enrollment MEXICO	1 Participants n=25 Participants	5 Participants n=26 Participants	6 Participants n=51 Participants	12 Participants n=27 Participants
Region of Enrollment NEW ZEALAND	3 Participants n=25 Participants	1 Participants n=26 Participants	0 Participants n=51 Participants	4 Participants n=27 Participants
Region of Enrollment POLAND	31 Participants n=25 Participants	28 Participants n=26 Participants	34 Participants n=51 Participants	93 Participants n=27 Participants
Region of Enrollment SLOVAKIA	2 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	2 Participants n=27 Participants
Region of Enrollment SOUTH KOREA	7 Participants n=25 Participants	6 Participants n=26 Participants	2 Participants n=51 Participants	15 Participants n=27 Participants
Region of Enrollment SPAIN	5 Participants n=25 Participants	1 Participants n=26 Participants	0 Participants n=51 Participants	6 Participants n=27 Participants
Region of Enrollment TAIWAN	0 Participants n=25 Participants	3 Participants n=26 Participants	1 Participants n=51 Participants	4 Participants n=27 Participants
Region of Enrollment TURKEY	1 Participants n=25 Participants	4 Participants n=26 Participants	2 Participants n=51 Participants	7 Participants n=27 Participants
Region of Enrollment UNITED STATES	10 Participants n=25 Participants	10 Participants n=26 Participants	13 Participants n=51 Participants	33 Participants n=27 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full analysis set (FAS) included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of Guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Combined Guselkumab 400 mg n=279 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Percentage of Participants in Clinical Remission at Week 12	6.5 Percentage of participants Interval 2.4 to 10.6	27.6 Percentage of participants Interval 22.4 to 32.8	—

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of Guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.

Percentage of participants in symptomatic remission at Week 12 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Combined Guselkumab 400 mg n=279 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Percentage of Participants in Symptomatic Remission at Week 12	20.9 Percentage of participants Interval 14.1 to 27.6	51.3 Percentage of participants Interval 45.4 to 57.1	—

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.

Percentage of participants with endoscopic improvement at Week 12 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Combined Guselkumab 400 mg n=279 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Percentage of Participants With Endoscopic Improvement at Week 12	12.9 Percentage of participants Interval 7.4 to 18.5	37.3 Percentage of participants Interval 31.6 to 42.9	—

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.

Percentage of participants in clinical response at Week 12 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Combined Guselkumab 400 mg n=279 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Percentage of Participants in Clinical Response at Week 12	34.5 Percentage of participants Interval 26.6 to 42.4	65.6 Percentage of participants Interval 60.0 to 71.2	—

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.

Percentage of participants with histologic-endoscopic mucosal improvement at Week 12 was reported. Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (\<) 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Combined Guselkumab 400 mg n=279 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12	10.8 Percentage of participants Interval 5.6 to 15.9	30.5 Percentage of participants Interval 25.1 to 35.9	—

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention.

Percentage of participants in clinical remission at Week 24 was reported. Clinical remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Combined Guselkumab 400 mg n=139 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w n=140 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Percentage of Participants in Clinical Remission at Week 24	9.4 Percentage of participants Interval 4.5 to 14.2	35.3 Percentage of participants Interval 27.3 to 43.2	36.4 Percentage of participants Interval 28.5 to 44.4

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention.

Percentage of participants in symptomatic remission at Week 24 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Combined Guselkumab 400 mg n=139 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w n=140 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Percentage of Participants in Symptomatic Remission at Week 24	25.2 Percentage of participants Interval 18.0 to 32.4	54.7 Percentage of participants Interval 46.4 to 63.0	50.0 Percentage of participants Interval 41.7 to 58.3

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention.

Percentage of participants with endoscopic improvement at Week 24 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Combined Guselkumab 400 mg n=139 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w n=140 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Percentage of Participants With Endoscopic Improvement at Week 24	12.2 Percentage of participants Interval 6.8 to 17.7	40.3 Percentage of participants Interval 32.1 to 48.4	45.0 Percentage of participants Interval 36.8 to 53.2

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention.

Percentage of participants in clinical response at Week 24 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by \>= 30% and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24.	Combined Guselkumab 400 mg n=139 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w n=140 Participants Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Percentage of Participants in Clinical Response at Week 24	30.9 Percentage of participants Interval 23.3 to 38.6	63.3 Percentage of participants Interval 55.3 to 71.3	61.4 Percentage of participants Interval 53.4 to 69.5

Adverse Events

Placebo (Before Rescue Medication)

Serious events: 17 serious events

Other events: 48 other events

Deaths: 1 deaths

Placebo - Guselkumab (After Rescue Medication)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Guselkumab 400 mg q4w - Guselkumab 100 mg q8w

Serious events: 5 serious events

Other events: 47 other events

Deaths: 0 deaths

Guselkumab 400 mg q4w - Guselkumab 200 mg q4w

Serious events: 6 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo (Before Rescue Medication) n=139 participants at risk Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. This arm includes data of all placebo participants excluding data after a participant was rescued with guselkumab.	Placebo - Guselkumab (After Rescue Medication) n=52 participants at risk All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment that is guselkumab 400 milligrams (mg) mg SC injection at Weeks 16, 20, and 24. Rescue Criteria: No improvement (no decrease) in Mayo endoscopy subscore at Week 12 as obtained during central review, when compared with baseline and a less than (\<) 2 point improvement (\<2 point decrease) in partial Mayo score at Weeks 12 and 16, when compared with baseline. This arm includes data occurred after a participant crossed over to guselkumab.	Guselkumab 400 mg q4w - Guselkumab 100 mg q8w n=139 participants at risk Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 100 mg SC injection every 8 weeks (q8w) starting from Week 16 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.	Guselkumab 400 mg q4w - Guselkumab 200 mg q4w n=140 participants at risk Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24.
Blood and lymphatic system disorders Anaemia	5.8% 8/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	3.8% 2/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	3.6% 5/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	3.6% 5/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
Gastrointestinal disorders Abdominal Pain	3.6% 5/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	0.00% 0/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	1.4% 2/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	1.4% 2/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
Gastrointestinal disorders Colitis Ulcerative	13.7% 19/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	1.9% 1/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	8.6% 12/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	5.0% 7/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
General disorders Injection Site Erythema	0.72% 1/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	1.9% 1/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	2.9% 4/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	4.3% 6/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
Infections and infestations Covid-19	3.6% 5/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	1.9% 1/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	3.6% 5/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	1.4% 2/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
Infections and infestations Nasopharyngitis	5.8% 8/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	0.00% 0/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	3.6% 5/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	2.9% 4/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
Infections and infestations Upper Respiratory Tract Infection	6.5% 9/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	0.00% 0/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	7.2% 10/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	3.6% 5/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
Musculoskeletal and connective tissue disorders Arthralgia	2.2% 3/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	0.00% 0/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	7.9% 11/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	5.0% 7/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
Nervous system disorders Headache	2.2% 3/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	0.00% 0/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	5.0% 7/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	3.6% 5/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
Skin and subcutaneous tissue disorders Alopecia	0.72% 1/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	0.00% 0/52 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	4.3% 6/139 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.	1.4% 2/140 • All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24 Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.

Additional Information

Senior Medical Leader Pediatrics Immunology

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Study site and investigator shall not publish study results except as required by law or as specified in a separate, written agreement between the sponsor and the study site or investigator. Sponsor will register the study and publish the study results in compliance with applicable law and may register the study or publish study results when not required.
Publication restrictions are in place

Restriction type: OTHER