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

Conditions

Ulcerative Colitis

Brief summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Hart A, Sridhar S, Venkat S, Lee T, Rusbuldt JJ, Richards D, Sisk C, Horowitz D, Tomsho L, Kannan AK, Ruane D, Van den Berge K, Rubin DT, Sands BE, De Hertogh G, Huang KG, Germinaro M, Cua D, Waterworth D, Freeman TC, Vetter ML, McRae B, Verstockt B, Branigan P.

2026-03-23

10.1136/bmjgast-2025-002153

P0564 Optimizing Ulcerative Colitis maintenance treatment: Indirect comparison on number needed to treat among interleukin-23p19 inhibitors highlights mirikizumab’s efficacy

L Peyrin-Biroulet, A Dignass, S S Hoque, V Jairath, L Kwapisz et al. (11 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.745

P0980 Association of endoscopic, histologic, and composite outcomes with long-term guselkumab efficacy in ulcerative colitis: 2-year results from the QUASAR long-term extension

F Magro, D T Rubin, G Lichtenstein, Yelina Alvarez, T Baker et al. (7 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.1161

DOP104 Efficacy and safety of guselkumab for ulcerative colitis through week 140 of the QUASAR long-term extension study

L Peyrin-Biroulet, B Bressler, A Dignass, T Hisamatsu, B E Sands et al. (13 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.141

OP10 Symptomatic improvement with intravenous guselkumab induction therapy is observed early in patients with moderately to severely active Ulcerative Colitis: post-hoc analysis of QUASAR

A Dignass, FUMIHITO HIRAI, Kazuo Ohtsuka, A Sasaki, Shinichi Yoshigoe et al. (9 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.010

Guselkumab in East Asians With Moderate‐to‐Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies

Baili Chen, Byong Duk Ye, Qian Cao, Fumihito Hirai, Masayuki Saruta et al. (13 authors)

Journal of Gastroenterology and Hepatology2025-06-261 citations

10.1111/jgh.17036

P1141 Guselkumab efficacy and safety in East Asian participants with moderate to severely active Ulcerative Colitis: Subgroup analysis of the Phase 2b/3 QUASAR induction and maintenance studies

Bin Chen, B D Ye, Qing Cao, Fumihito Hirai, Masayuki Saruta et al. (11 authors)

Journal of Crohn s and Colitis2025-01-01

10.1093/ecco-jcc/jjae190.1315

P1169 Guselkumab maintenance treatment improves health-related quality of life in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR maintenance study

B Bressler, Laurent Peyrin‐Biroulet, Waqqas Afif, Mark Samaan, Shu‐Chen Wei et al. (11 authors)

Journal of Crohn s and Colitis2025-01-01

10.1093/ecco-jcc/jjae190.1343

Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies.

Rubin DT, Allegretti JR, Panés J, Shipitofsky N, Yarandi SS, Huang KG, Germinaro M, Wilson R, Zhang H, Johanns J, Feagan BG, Hisamatsu T, Lichtenstein GR, Bressler B, Peyrin-Biroulet L, Sands BE, Dignass A, QUASAR Study Group.

2024-12-1741 citations

10.1016/s0140-6736(24)01927-5

OP23 Guselkumab induction restores intestinal immune homeostasis and promotes epithelial repair in moderately to severely active Ulcerative Colitis

Saranya Sridhar, Andrew Hart, S Venkat, Darren Ruane, Daniel Horowitz et al. (18 authors)

Journal of Crohn s and Colitis2024-01-013 citations

10.1093/ecco-jcc/jjad212.0023

DOP52 Guselkumab improves symptoms of fatigue in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR induction study results at Week 12

Axel Dignaß, Julián Panés, David T. Rubin, Kuo‐How Huang, Matthew Germinaro et al. (15 authors)

Journal of Crohn s and Colitis2024-01-011 citations

10.1093/ecco-jcc/jjad212.0092

DOP49 Guselkumab improves health-related quality of life as measured by PROMIS-29 in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR induction study

Julián Panés, Axel Dignaß, Gary R. Lichtenstein, Kuo‐How Huang, Matthew Germinaro et al. (15 authors)

Journal of Crohn s and Colitis2024-01-01

10.1093/ecco-jcc/jjad212.0089

P294 ArgesUCEIS: A high-performance, generalizable AI models for scoring Ulcerative Colitis Endoscopic Index of Severity (UCEIS) component scores in endoscopy videos

Krishna Chaitanya, Natalia Zemlianskaia, Pablo F. Damasceno, E. Scherer, A. Ulloa Cerna et al. (16 authors)

Journal of Crohn s and Colitis2024-01-01

10.1093/ecco-jcc/jjad212.0424

P213 ArgesMES: A high-performance, generalizable AI model for scoring Ulcerative Colitis severity from endoscopy videos

K Chaitanya, Natalia Zemlianskaia, Pablo F. Damasceno, E. Scherer, Alvaro Ulloa Cerna et al. (16 authors)

Journal of Crohn s and Colitis2024-01-01

10.1093/ecco-jcc/jjad212.0343

S1059 The Efficacy of Induction Treatment With Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: Phase 3 QUASAR Induction Study Results at Week 12 by Prior Advanced Therapy History

Brian Bressler, Laurent Peyrin‐Biroulet, Jessica R. Allegretti, Kuan‐Hsiang Gary Huang, Matthew Germinaro et al. (14 authors)

The American Journal of Gastroenterology2023-10-011 citations

10.14309/01.ajg.0000953876.70607.b0

S844 Early Symptomatic Improvement With Guselkumab Induction Treatment in Moderately to Severely Active Ulcerative Colitis: Results From the Phase 3 QUASAR Induction Study

Gary R. Lichtenstein, Axel Dignaß, David T. Rubin, Shadi Yarandi, Kuan‐Hsiang Gary Huang et al. (14 authors)

The American Journal of Gastroenterology2023-10-01

10.14309/01.ajg.0000953016.91904.06

Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study.

Peyrin-Biroulet L, Allegretti JR, Rubin DT, Bressler B, Germinaro M, Huang KG, Shipitofsky N, Zhang H, Wilson R, Han C, Feagan BG, Sandborn WJ, Panés J, Hisamatsu T, Lichtenstein GR, Sands BE, Dignass A, QUASAR Study Group.

2023-09-0170 citations

10.1053/j.gastro.2023.08.038

P493 QUASAR Induction Study 1 Cumulative Response to Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis

Laurent Peyrin‐Biroulet, Daniel S. Rubin, Gary Lichtenstein, Nicole Shipitofsky, Kuo‐How Huang et al. (18 authors)

Journal of Crohn s and Colitis2023-01-30

10.1093/ecco-jcc/jjac190.0623

S817 The Effect of Guselkumab Induction Therapy on Inflammatory Biomarkers in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Results Through Week 12

Gary R. Lichtenstein, Axel Dignaß, William J. Sandborn, K H G Huang, Matthew Germinaro et al. (13 authors)

The American Journal of Gastroenterology2022-10-01

10.14309/01.ajg.0000859908.57086.61

S744 QUASAR Induction Study 1 Cumulative Response to Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis

Bruce E. Sands, David T. Rubin, Gary R. Lichtenstein, Nicole Shipitofsky, K H G Huang et al. (17 authors)

The American Journal of Gastroenterology2022-10-01

10.14309/01.ajg.0000902204.49896.53

S717 The Effect of Guselkumab Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Results at Week 12 by Prior Inadequate Response or Intolerance to Advanced Therapy

David T. Rubin, Jessica R. Allegretti, Bruce E. Sands, Kuan‐Hsiang Gary Huang, Mary Kavalam et al. (12 authors)

The American Journal of Gastroenterology2022-10-01

10.14309/01.ajg.0000859508.24499.4b

OP23 The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active Ulcerative Colitis: Phase 2b QUASAR Study results through week 12

Axel Dignaß, David T. Rubin, Brian Bressler, Kuo‐How Huang, Nicole Shipitofsky et al. (15 authors)

Journal of Crohn s and Colitis2022-01-0115 citations

10.1093/ecco-jcc/jjab232.022

Interventions

DRUGPlacebo

Participants will receive matching placebo IV or SC.

DRUGGuselkumab

Participants will receive guselkumab IV or SC.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Documented diagnosis of ulcerative colitis (UC) * Moderately to severely active UC, defined by modified Mayo score * Demonstrated inadequate response or intolerance to medical therapies specified in the protocol * Screening laboratory test results within the parameters specified in the protocol

Exclusion criteria

* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease * UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon * Presence of a stoma * Presence or history of a fistula * Receiving prohibited medications and/or treatment

Design outcomes

Primary

Measure	Time frame	Description
Induction Study 1: Percentage of Participants With Clinical Response at Week I-12	At Week I-12	Clinical response was defined as a decrease from induction 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 (Week 0 of IS-1) 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 as determined during central review, 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. This outcome measure was planned to be analyzed for specified arms only.
Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12	At Week I-12	Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, 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. This outcome measure was planned to be analyzed for specified arms only.
Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44	At Week M-44	Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, 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. This outcome measure was planned to be analyzed for randomized arms only.

Secondary

Measure	Time frame
Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12	At Week I-12
Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12	At Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12	At Week I-12
Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12	At Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Clinical Response at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4	At Week I-4
Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2	At Week I-2
Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12	At Week I-12
Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Clinical Response at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance Baseline	At Week M-44
Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44	At Week M-44

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Jordan, Latvia, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States

Contacts

STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial

Janssen Research & Development, LLC

Participant flow

Recruitment details

This study consisted of 3 separate studies: induction study 1 (IS-1), induction study 2 (IS-2) and maintenance study (MS). In IS-1 and IS-2, participants with modified Mayo score (MMS) of 4 to 9 at baseline (Induction Week 0 \[Week I-0\]) with inadequate response or failed to tolerate conventional or advanced therapy were enrolled.

Pre-assignment details

IS-1 and IS-2 participants with clinical response (CR) at Week I-12/Week I-24 entered MS. Participants who had no CR at Week I-24 stopped study drug and had safety follow-up up to 12 weeks after last dose. CR: decrease from induction baseline in MMS by greater than or equal to (\>=)30 percent (%) and \>=2 points, with either \>=1 point decrease from baseline in rectal bleeding (RB) subscore/RB subscore of 0 or 1. MMS contained 3 subscores: stool frequency, rectal bleeding and endoscopic subscore.

Participants by arm

Arm	Count
IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8 Participants received single dose of placebo (matching to guselkumab) intravenous (IV) infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.	105
IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8 Participants received single dose of guselkumab 200 milligrams (mg) IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.	101
IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8 Participants received single dose of guselkumab 400 mg IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study and participants who did not achieve clinical response at Week I-12 entered IS-1 Period 2.	107
IS-2: Period 1: Placebo IV at Weeks I-0, I-4 and I-8 Participants received single dose of placebo (matched to guselkumab) IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study. Participants who did not achieve clinical response at Week I-12 entered IS-2 Period 2.	280
IS-2: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8 Participants received single dose of guselkumab 200 mg IV infusion at Weeks I-0, I-4 and I-8. At Week I-12, participants were evaluated for clinical response. Participants who achieved clinical response at Week I-12 entered the maintenance study. Participants who did not achieve clinical response at Week I-12 entered IS-2 Period 2.	421
Total	1,014

Baseline characteristics

Characteristic	IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8	IS-2: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	IS-2: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	Total
Age, Continuous	41.2 Years STANDARD_DEVIATION 15.05	43.3 Years STANDARD_DEVIATION 14.28	40.4 Years STANDARD_DEVIATION 13.84	39.8 Years STANDARD_DEVIATION 13.43	41 Years STANDARD_DEVIATION 13.9	40.9 Years STANDARD_DEVIATION 13.93
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	5 Participants	4 Participants	21 Participants	25 Participants	59 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants	92 Participants	98 Participants	240 Participants	368 Participants	895 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants	4 Participants	5 Participants	19 Participants	28 Participants	60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	24 Participants	23 Participants	27 Participants	62 Participants	88 Participants	224 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	1 Participants	3 Participants	4 Participants	10 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	3 Participants	5 Participants	10 Participants	22 Participants	43 Participants
Race (NIH/OMB) White	77 Participants	73 Participants	74 Participants	205 Participants	304 Participants	733 Participants
Region of Enrollment Argentina	0 Participants	0 Participants	2 Participants	5 Participants	10 Participants	17 Participants
Region of Enrollment Australia	2 Participants	1 Participants	2 Participants	7 Participants	14 Participants	26 Participants
Region of Enrollment Belgium	1 Participants	0 Participants	0 Participants	3 Participants	3 Participants	7 Participants
Region of Enrollment Brazil	0 Participants	2 Participants	0 Participants	12 Participants	15 Participants	29 Participants
Region of Enrollment Bulgaria	1 Participants	0 Participants	1 Participants	2 Participants	3 Participants	7 Participants
Region of Enrollment Canada	0 Participants	0 Participants	0 Participants	2 Participants	5 Participants	7 Participants
Region of Enrollment China	7 Participants	2 Participants	2 Participants	26 Participants	35 Participants	72 Participants
Region of Enrollment Czech Republic	1 Participants	2 Participants	1 Participants	11 Participants	17 Participants	32 Participants
Region of Enrollment France	5 Participants	10 Participants	6 Participants	10 Participants	30 Participants	61 Participants
Region of Enrollment Germany	3 Participants	3 Participants	3 Participants	11 Participants	8 Participants	28 Participants
Region of Enrollment Hungary	4 Participants	5 Participants	3 Participants	11 Participants	17 Participants	40 Participants
Region of Enrollment Ireland	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Region of Enrollment Israel	0 Participants	1 Participants	1 Participants	5 Participants	7 Participants	14 Participants
Region of Enrollment Italy	5 Participants	2 Participants	6 Participants	14 Participants	15 Participants	42 Participants
Region of Enrollment Japan	9 Participants	12 Participants	15 Participants	25 Participants	33 Participants	94 Participants
Region of Enrollment Jordan	0 Participants	0 Participants	0 Participants	16 Participants	18 Participants	34 Participants
Region of Enrollment Latvia	0 Participants	0 Participants	0 Participants	5 Participants	3 Participants	8 Participants
Region of Enrollment Malaysia	0 Participants	0 Participants	0 Participants	3 Participants	4 Participants	7 Participants
Region of Enrollment New Zealand	0 Participants	0 Participants	1 Participants	2 Participants	5 Participants	8 Participants
Region of Enrollment Poland	19 Participants	22 Participants	24 Participants	47 Participants	71 Participants	183 Participants
Region of Enrollment Portugal	2 Participants	2 Participants	1 Participants	1 Participants	0 Participants	6 Participants
Region of Enrollment Russian Federation	9 Participants	7 Participants	6 Participants	18 Participants	20 Participants	60 Participants
Region of Enrollment Serbia	0 Participants	0 Participants	0 Participants	5 Participants	5 Participants	10 Participants
Region of Enrollment Slovakia	0 Participants	0 Participants	0 Participants	2 Participants	12 Participants	14 Participants
Region of Enrollment South Korea	6 Participants	7 Participants	5 Participants	2 Participants	11 Participants	31 Participants
Region of Enrollment Spain	2 Participants	1 Participants	1 Participants	2 Participants	2 Participants	8 Participants
Region of Enrollment Sweden	2 Participants	1 Participants	0 Participants	0 Participants	3 Participants	6 Participants
Region of Enrollment Taiwan	2 Participants	1 Participants	3 Participants	2 Participants	1 Participants	9 Participants
Region of Enrollment Turkey	0 Participants	0 Participants	2 Participants	3 Participants	11 Participants	16 Participants
Region of Enrollment Ukraine	16 Participants	16 Participants	14 Participants	13 Participants	20 Participants	79 Participants
Region of Enrollment United Kingdom	3 Participants	1 Participants	1 Participants	3 Participants	6 Participants	14 Participants
Region of Enrollment United States	6 Participants	3 Participants	7 Participants	11 Participants	17 Participants	44 Participants
Sex: Female, Male Female	39 Participants	41 Participants	48 Participants	119 Participants	183 Participants	430 Participants
Sex: Female, Male Male	66 Participants	60 Participants	59 Participants	161 Participants	238 Participants	584 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk
deaths Total, all-cause mortality	0 / 109	0 / 108	0 / 111	0 / 67	0 / 79	2 / 296	1 / 440	0 / 172	0 / 129	0 / 203	0 / 197	0 / 199	0 / 122	0 / 125	0 / 75	0 / 23	0 / 31
other Total, other adverse events	49 / 108	33 / 108	38 / 111	17 / 67	15 / 79	88 / 295	118 / 440	38 / 171	37 / 129	112 / 203	93 / 197	109 / 199	69 / 122	76 / 125	28 / 75	14 / 23	20 / 31
serious Total, serious adverse events	7 / 108	1 / 108	3 / 111	2 / 67	3 / 79	21 / 295	13 / 440	4 / 171	3 / 129	3 / 203	5 / 197	12 / 199	13 / 122	7 / 125	2 / 75	1 / 23	2 / 31

Outcome results

Primary

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

Clinical response was defined as a decrease from induction 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 (Week 0 of IS-1) 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 as determined during central review, 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. This outcome measure was planned to be analyzed for specified arms only.

Time frame: At Week I-12

Population: FAS: all randomized participants (in IS-1) with a modified Mayo score of 5 to 9 who received at least 1 (partial or complete) dose of study intervention.

Arm	Measure	Value (NUMBER)
IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Induction Study 1: Percentage of Participants With Clinical Response at Week I-12	27.6 Percentage of participants
IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	Induction Study 1: Percentage of Participants With Clinical Response at Week I-12	61.4 Percentage of participants
IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8	Induction Study 1: Percentage of Participants With Clinical Response at Week I-12	60.7 Percentage of participants

p-value: <0.00195% CI: [20.9, 46.3]Cochran-Mantel-Haenszel (CMH) chi-square

p-value: <0.00195% CI: [20.8, 45.4]CMH chi-square test

Primary

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, 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. This outcome measure was planned to be analyzed for specified arms only.

Time frame: At Week I-12

Population: Full analysis set included all randomized participants (in IS-2) with a modified Mayo score of 5 to 9 who received at least 1 (partial or complete) dose of study intervention.

Arm	Measure	Value (NUMBER)
IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12	7.9 Percentage of participants
IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12	22.6 Percentage of participants

p-value: <0.00195% CI: [9.9, 19.9]CMH chi-square test

Primary

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, 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. This outcome measure was planned to be analyzed for randomized arms only.

Time frame: At Week M-44

Population: Randomized full analysis set included all participants with a modified Mayo score of 5 to 9 who were randomized and received at least 1 (partial or complete) dose of study intervention in the maintenance study.

Arm	Measure	Value (NUMBER)
IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44	18.9 Percentage of participants
IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44	45.2 Percentage of participants
IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8	Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44	50.0 Percentage of participants

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12

Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12

Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12

Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12

Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12

Induction Study 2: Percentage of Participants With Clinical Response at Week I-12

Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12

Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12

Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12

Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12

Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12

Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12

Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2

Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4

Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance Baseline

Maintenance Study: Percentage of Participants With Clinical Response at Week M-44

Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44

Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44

Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44

Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44

Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44

Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44

Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44