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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03466411
Acronym
GALAXI
Enrollment
1409
Registered
2018-03-15
Start date
2018-04-13
Completion date
2028-01-28
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief summary

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

Detailed description

This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.

Interventions

DRUGGuselkumab Dose 1

Guselkumab will be administered by IV infusion.

DRUGGuselkumab Dose 2

Guselkumab will be administered by SC injection.

DRUGGuselkumab Dose 3

Guselkumab will be administered by IV infusion.

DRUGGuselkumab Dose 4

Guselkumab will be administered by IV infusion.

DRUGGuselkumab Dose 5

Guselkumab will be by SC injection.

DRUGGuselkumab

Guselkumab will be administered by IV infusion and SC injection.

DRUGUstekinumab

Ustekinumab will be administered by IV infusion and SC injection.

DRUGPlacebo

Placebo will be administered as IV infusion.

Sponsors

Janssen Research & Development, LLC
Lead SponsorINDUSTRY

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

* Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD) * Have screening laboratory test results within the protocol specified parameters * A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline * Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion criteria

* Current diagnosis of ulcerative colitis or indeterminate colitis * Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation * Unstable doses of concomitant Crohn's disease therapy * Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol * Any medical contraindications preventing study participation

Design outcomes

Primary

MeasureTime frameDescription
GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12Baseline and Week 12The 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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity. Baseline was defined as the last observation prior to or at the date of the first study intervention.
Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48Weeks 48Clinical response was defined as a decrease from baseline (BL) in CDAI score greater than or equal to (\>=) 100 points or CDAI score \<150. Clinical remission was defined as a 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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.
Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48Weeks 48CR: decrease from BL in CDAI score \>=100/\<150. ER: \>=50% improvement from BL in SES-CD score/SES-CD score \<=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence \& size of ulcer, extent of ulcerated surface, extent of affected surface, presence \& type of narrowing) across 5 ileocolonic segments (ileum; right, left \& transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.
Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48Weeks 48Clinical response was defined as a decrease from baseline in CDAI score \>= 100 points or CDAI score \<150. Clinical remission was defined as a 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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.
Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48Weeks 48CR: decrease from BL in CDAI score \>=100/\<150. ER: \>=50% improvement from BL in SES-CD score/SES-CD score \<=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence \& size of ulcer, extent of ulcerated surface, extent of affected surface, presence \& type of narrowing) across 5 ileocolonic segments (ileum; right, left \& transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.
Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12Week 12Clinical remission was defined as a 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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.
Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12Week 12Endoscopic response was defined as \>=50% improvement from baseline in SES-CD score or SES-CD score \<=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.
Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12Week 12Clinical remission was defined as a 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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.
Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12Week 12Endoscopic response was defined as \>=50% improvement from baseline in SES-CD score or SES-CD score \<=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

Secondary

MeasureTime frame
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Endoscopic Remission at Week 48At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission at Week 48 and Endoscopic Response at Week 48At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Remission at Week 48At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48At Week 48
GALAXI 1: Percentage of Participants With Clinical Remission at Week 12At Week 12
GALAXI 1: Percentage of Participants With Clinical Response at Week 12At Week 12
GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12At Week 12
GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12At Week 12
GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4At Week 4
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12At Week 12

Countries

Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Colombia, Croatia, Czechia, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, North Macedonia, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Slovakia, South Korea, Spain, Taiwan, Tunisia, 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: Phase 2 dose-ranging study (GALAXI 1) and 2 identical Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). Participants with moderately to severely active Crohn's disease were enrolled in these studies.

Pre-assignment details

Results were presented through Week 48 with a data cutoff date of 20 August 2020 (GALAXI 1), 20 October 2023 (GALAXI 2) and 16 October 2023 (GALAXI 3). At Week 48, participants who continued to benefit from treatment entered long-term extension period and continued to receive maintenance dose up to Week 236 which is still ongoing. Results of remaining duration of the study will be reported after study completion.

Participants by arm

ArmCount
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w
Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.
73
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w
Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.
73
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w
Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.
73
GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w
Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.
71
GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8w
Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.
70
GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w
Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.
148
GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w
Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.
148
GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w
Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.
150
GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.
77
GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w
Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.
151
GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w
Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.
148
GALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w
Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.
150
GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.
76
Total1,408

Baseline characteristics

CharacteristicTotalGALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
56 Participants5 Participants7 Participants4 Participants2 Participants2 Participants6 Participants4 Participants7 Participants1 Participants8 Participants2 Participants7 Participants1 Participants
Age, Categorical
Between 18 and 65 years
1352 Participants68 Participants66 Participants69 Participants69 Participants68 Participants142 Participants144 Participants143 Participants76 Participants143 Participants146 Participants143 Participants75 Participants
Age, Continuous37.2 Years
STANDARD_DEVIATION 13.14
40.2 Years
STANDARD_DEVIATION 14.28
39.3 Years
STANDARD_DEVIATION 15.51
41.5 Years
STANDARD_DEVIATION 14.41
36.3 Years
STANDARD_DEVIATION 12.08
39 Years
STANDARD_DEVIATION 12.79
36.2 Years
STANDARD_DEVIATION 13.03
37.3 Years
STANDARD_DEVIATION 12.86
37 Years
STANDARD_DEVIATION 12.76
34.1 Years
STANDARD_DEVIATION 11.81
37.6 Years
STANDARD_DEVIATION 13.4
34.8 Years
STANDARD_DEVIATION 11.48
37.9 Years
STANDARD_DEVIATION 13.61
35.8 Years
STANDARD_DEVIATION 12.48
Ethnicity (NIH/OMB)
Hispanic or Latino
65 Participants3 Participants5 Participants4 Participants0 Participants4 Participants8 Participants5 Participants7 Participants2 Participants5 Participants7 Participants11 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1295 Participants69 Participants64 Participants66 Participants69 Participants64 Participants136 Participants139 Participants137 Participants71 Participants142 Participants136 Participants131 Participants71 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
48 Participants1 Participants4 Participants3 Participants2 Participants2 Participants4 Participants4 Participants6 Participants4 Participants4 Participants5 Participants8 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants0 Participants0 Participants2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
257 Participants6 Participants10 Participants9 Participants8 Participants5 Participants28 Participants34 Participants32 Participants17 Participants28 Participants38 Participants23 Participants19 Participants
Race (NIH/OMB)
Black or African American
23 Participants2 Participants2 Participants0 Participants1 Participants3 Participants1 Participants3 Participants3 Participants0 Participants1 Participants0 Participants4 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
11 Participants3 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants2 Participants0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
35 Participants1 Participants2 Participants3 Participants0 Participants4 Participants2 Participants3 Participants4 Participants2 Participants4 Participants2 Participants6 Participants2 Participants
Race (NIH/OMB)
White
1080 Participants61 Participants59 Participants58 Participants61 Participants58 Participants117 Participants108 Participants111 Participants56 Participants118 Participants107 Participants116 Participants50 Participants
Region of Enrollment
Australia
22 Participants1 Participants0 Participants0 Participants0 Participants0 Participants5 Participants2 Participants6 Participants1 Participants2 Participants1 Participants3 Participants1 Participants
Region of Enrollment
Austria
3 Participants1 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
Belarus
10 Participants2 Participants1 Participants0 Participants3 Participants2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants
Region of Enrollment
Belgium
5 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants1 Participants1 Participants1 Participants0 Participants
Region of Enrollment
Bosnia and Herzegovina
14 Participants1 Participants1 Participants0 Participants1 Participants0 Participants2 Participants1 Participants3 Participants1 Participants0 Participants2 Participants2 Participants0 Participants
Region of Enrollment
Brazil
53 Participants0 Participants0 Participants0 Participants0 Participants0 Participants6 Participants7 Participants9 Participants2 Participants8 Participants6 Participants12 Participants3 Participants
Region of Enrollment
Canada
27 Participants0 Participants0 Participants2 Participants0 Participants0 Participants1 Participants6 Participants4 Participants1 Participants2 Participants4 Participants5 Participants2 Participants
Region of Enrollment
China
120 Participants0 Participants0 Participants0 Participants0 Participants0 Participants18 Participants19 Participants10 Participants12 Participants15 Participants22 Participants12 Participants12 Participants
Region of Enrollment
Colombia
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Region of Enrollment
Croatia
4 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants0 Participants1 Participants0 Participants
Region of Enrollment
Czech Republic
16 Participants1 Participants1 Participants1 Participants1 Participants0 Participants2 Participants0 Participants0 Participants3 Participants1 Participants4 Participants1 Participants1 Participants
Region of Enrollment
France
30 Participants2 Participants2 Participants6 Participants1 Participants2 Participants4 Participants2 Participants4 Participants2 Participants1 Participants1 Participants2 Participants1 Participants
Region of Enrollment
Georgia
10 Participants1 Participants3 Participants1 Participants1 Participants1 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants1 Participants0 Participants
Region of Enrollment
Germany
27 Participants3 Participants4 Participants0 Participants2 Participants2 Participants2 Participants4 Participants2 Participants0 Participants4 Participants2 Participants1 Participants1 Participants
Region of Enrollment
Greece
1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
Hungary
20 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants4 Participants5 Participants0 Participants4 Participants1 Participants4 Participants1 Participants
Region of Enrollment
India
10 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants2 Participants1 Participants2 Participants2 Participants2 Participants0 Participants
Region of Enrollment
Israel
26 Participants2 Participants2 Participants2 Participants2 Participants0 Participants4 Participants1 Participants0 Participants2 Participants0 Participants9 Participants0 Participants2 Participants
Region of Enrollment
Italy
15 Participants2 Participants2 Participants2 Participants0 Participants1 Participants1 Participants0 Participants1 Participants1 Participants3 Participants1 Participants0 Participants1 Participants
Region of Enrollment
Japan
68 Participants3 Participants5 Participants6 Participants4 Participants2 Participants4 Participants7 Participants13 Participants1 Participants9 Participants6 Participants4 Participants4 Participants
Region of Enrollment
Jordan
42 Participants1 Participants1 Participants0 Participants2 Participants1 Participants4 Participants3 Participants4 Participants4 Participants9 Participants3 Participants9 Participants1 Participants
Region of Enrollment
Korea, South
32 Participants1 Participants2 Participants1 Participants3 Participants2 Participants2 Participants5 Participants4 Participants2 Participants2 Participants3 Participants3 Participants2 Participants
Region of Enrollment
Latvia
10 Participants3 Participants1 Participants1 Participants0 Participants0 Participants1 Participants1 Participants1 Participants0 Participants1 Participants1 Participants0 Participants0 Participants
Region of Enrollment
Lebanon
19 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants4 Participants1 Participants1 Participants2 Participants3 Participants4 Participants2 Participants
Region of Enrollment
Lithuania
3 Participants0 Participants0 Participants2 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
Macedonia
9 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants1 Participants1 Participants1 Participants1 Participants1 Participants1 Participants
Region of Enrollment
Malaysia
15 Participants1 Participants2 Participants0 Participants1 Participants0 Participants3 Participants1 Participants2 Participants1 Participants0 Participants2 Participants1 Participants1 Participants
Region of Enrollment
Netherlands
12 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants4 Participants4 Participants1 Participants2 Participants0 Participants
Region of Enrollment
New Zealand
12 Participants1 Participants0 Participants0 Participants0 Participants0 Participants4 Participants0 Participants3 Participants1 Participants2 Participants1 Participants0 Participants0 Participants
Region of Enrollment
Poland
292 Participants11 Participants18 Participants15 Participants21 Participants25 Participants33 Participants24 Participants33 Participants10 Participants26 Participants32 Participants28 Participants16 Participants
Region of Enrollment
Portugal
4 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants
Region of Enrollment
Russian Federation
115 Participants6 Participants3 Participants8 Participants4 Participants3 Participants14 Participants14 Participants14 Participants10 Participants13 Participants9 Participants9 Participants8 Participants
Region of Enrollment
Saudi Arabia
2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Region of Enrollment
Serbia
64 Participants2 Participants3 Participants3 Participants6 Participants2 Participants8 Participants9 Participants7 Participants3 Participants5 Participants2 Participants8 Participants6 Participants
Region of Enrollment
Slovakia
17 Participants1 Participants1 Participants0 Participants2 Participants2 Participants1 Participants3 Participants1 Participants0 Participants3 Participants2 Participants1 Participants0 Participants
Region of Enrollment
Spain
12 Participants1 Participants1 Participants1 Participants0 Participants1 Participants1 Participants0 Participants2 Participants1 Participants1 Participants0 Participants3 Participants0 Participants
Region of Enrollment
Taiwan
7 Participants1 Participants1 Participants1 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants
Region of Enrollment
Tunisia
19 Participants0 Participants0 Participants0 Participants0 Participants0 Participants3 Participants5 Participants1 Participants1 Participants5 Participants2 Participants1 Participants1 Participants
Region of Enrollment
Turkey
10 Participants1 Participants1 Participants0 Participants2 Participants1 Participants1 Participants2 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants
Region of Enrollment
Ukraine
106 Participants9 Participants7 Participants7 Participants7 Participants6 Participants11 Participants12 Participants7 Participants8 Participants11 Participants10 Participants7 Participants4 Participants
Region of Enrollment
United Kingdom
5 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants0 Participants3 Participants0 Participants
Region of Enrollment
United States
119 Participants14 Participants10 Participants13 Participants6 Participants14 Participants7 Participants6 Participants8 Participants2 Participants10 Participants9 Participants15 Participants5 Participants
Sex: Female, Male
Female
586 Participants35 Participants29 Participants27 Participants26 Participants26 Participants59 Participants76 Participants62 Participants35 Participants59 Participants60 Participants66 Participants26 Participants
Sex: Female, Male
Male
822 Participants38 Participants44 Participants46 Participants45 Participants44 Participants89 Participants72 Participants88 Participants42 Participants92 Participants88 Participants84 Participants50 Participants

Adverse events

Event typeEG000
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
deaths
Total, all-cause mortality
0 / 730 / 730 / 730 / 710 / 700 / 430 / 1480 / 1490 / 1500 / 770 / 490 / 1510 / 1480 / 1500 / 760 / 51
other
Total, other adverse events
33 / 7334 / 7334 / 7344 / 7127 / 7016 / 4380 / 14866 / 14878 / 15021 / 7715 / 4980 / 15169 / 14873 / 15030 / 7619 / 51
serious
Total, serious adverse events
5 / 735 / 736 / 739 / 716 / 700 / 436 / 14819 / 14818 / 1506 / 773 / 4915 / 15113 / 14817 / 15010 / 766 / 51

Outcome results

Primary

GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12

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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity. Baseline was defined as the last observation prior to or at the date of the first study intervention.

Time frame: Baseline and Week 12

Population: The primary efficacy analysis set consisted of randomized participants who received at least 1 dose of study intervention (including a partial dose), except for those participants whose induction dosing was discontinued as a result of the urgent safety measure. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. This outcome measure was planned to be collected and analyzed for specified arms only.

ArmMeasureValue (MEAN)Dispersion
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12-143.7 Units on a scaleStandard Deviation 96.58
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12-139.2 Units on a scaleStandard Deviation 100.71
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12-159.8 Units on a scaleStandard Deviation 110.52
GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4wGALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12-34.4 Units on a scaleStandard Deviation 104.85
p-value: <0.00195% CI: [89.8, 158.7]Mixed Model for Repeated Measure
p-value: <0.00195% CI: [68.5, 136.9]Mixed Model for Repeated Measure
p-value: <0.00195% CI: [73.9, 143.5]Mixed Model for Repeated Measure
Primary

Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

Clinical response was defined as a decrease from baseline (BL) in CDAI score greater than or equal to (\>=) 100 points or CDAI score \<150. Clinical remission was defined as a 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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Time frame: Weeks 48

Population: The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the simple endoscopic score for crohn's disease (SES-CD) eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

ArmMeasureValue (NUMBER)
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 4854.8 Percentage of participants
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 4849.0 Percentage of participants
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 4811.8 Percentage of participants
p-value: <0.00195% CI: [27.3, 48.9]Mantel Haenszel
p-value: <0.00195% CI: [31.6, 53.9]Mantel Haenszel
Primary

Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

CR: decrease from BL in CDAI score \>=100/\<150. ER: \>=50% improvement from BL in SES-CD score/SES-CD score \<=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence & size of ulcer, extent of ulcerated surface, extent of affected surface, presence & type of narrowing) across 5 ileocolonic segments (ileum; right, left & transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.

Time frame: Weeks 48

Population: The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

ArmMeasureValue (NUMBER)
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 4838.4 Percentage of participants
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 4839.2 Percentage of participants
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 485.3 Percentage of participants
p-value: <0.00195% CI: [24.1, 43.2]Mantel Haenszel
p-value: <0.00195% CI: [23.5, 42.4]Mantel Haenszel
Primary

Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

Clinical response was defined as a decrease from baseline in CDAI score \>= 100 points or CDAI score \<150. Clinical remission was defined as a 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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Time frame: Weeks 48

Population: The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

ArmMeasureValue (NUMBER)
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 4848.0 Percentage of participants
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 4846.9 Percentage of participants
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 4812.5 Percentage of participants
p-value: <0.00195% CI: [23.2, 45.3]Mantel Haenszel
p-value: <0.00195% CI: [23.5, 46.5]Mantel Haenszel
Primary

Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

CR: decrease from BL in CDAI score \>=100/\<150. ER: \>=50% improvement from BL in SES-CD score/SES-CD score \<=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence & size of ulcer, extent of ulcerated surface, extent of affected surface, presence & type of narrowing) across 5 ileocolonic segments (ileum; right, left & transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.

Time frame: Weeks 48

Population: The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

ArmMeasureValue (NUMBER)
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 4836.0 Percentage of participants
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 4833.6 Percentage of participants
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 485.6 Percentage of participants
p-value: <0.00195% CI: [18.7, 37.1]Mantel Haenszel
p-value: <0.00195% CI: [21.3, 40.3]Mantel Haenszel
Primary

Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12

Clinical remission was defined as a 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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Time frame: Week 12

Population: Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 2 Groups 1 and 2, and for participants who received placebo in GALAXI 2 Group 4.

ArmMeasureValue (NUMBER)
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wRegional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 1222.4 Percentage of participants
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wRegional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 1247.1 Percentage of participants
p-value: <0.00195% CI: [14.1, 36.2]Mantel Haenszel
Primary

Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12

Endoscopic response was defined as \>=50% improvement from baseline in SES-CD score or SES-CD score \<=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

Time frame: Week 12

Population: Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 2 Groups 1 and 2, and for participants who received placebo in GALAXI 2 Group 4.

ArmMeasureValue (NUMBER)
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wRegional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 1210.5 Percentage of participants
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wRegional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 1237.7 Percentage of participants
p-value: <0.00195% CI: [19.3, 36.1]Mantel Haenszel
Primary

Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12

Clinical remission was defined as a 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 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Time frame: Week 12

Population: Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 3 Groups 1 and 2, and for participants who received placebo in GALAXI 3 Group 4.

ArmMeasureValue (NUMBER)
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wRegional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 1215.3 Percentage of participants
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wRegional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 1247.1 Percentage of participants
p-value: <0.00195% CI: [21.1, 41.3]Mantel Haenszel
Primary

Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12

Endoscopic response was defined as \>=50% improvement from baseline in SES-CD score or SES-CD score \<=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

Time frame: Week 12

Population: Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 3 Groups 1 and 2, and for participants who received placebo in GALAXI 3 Group 4.

ArmMeasureValue (NUMBER)
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wRegional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 1213.9 Percentage of participants
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wRegional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 1236.2 Percentage of participants
p-value: <0.00195% CI: [12.2, 31.9]Mantel Haenszel
Secondary

GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12

Time frame: At Week 12

Secondary

GALAXI 1: Percentage of Participants With Clinical Remission at Week 12

Time frame: At Week 12

Secondary

GALAXI 1: Percentage of Participants With Clinical Response at Week 12

Time frame: At Week 12

Secondary

GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12

Time frame: At Week 12

Secondary

GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12

Time frame: At Week 12

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12

Time frame: At Week 12

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48

Time frame: At Week 48

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48

Time frame: At Week 48

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Endoscopic Remission at Week 48

Time frame: At Week 48

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12

Time frame: At Week 12

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48

Time frame: At Week 48

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4

Time frame: At Week 4

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48

Time frame: At Week 48

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12

Time frame: At Week 12

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48

Time frame: At Week 48

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12

Time frame: At Week 12

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48

Time frame: At Week 48

Secondary

Global: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12

Time frame: At Week 12

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission at Week 48 and Endoscopic Response at Week 48

Time frame: At Week 48

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48

Time frame: At Week 48

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48

Time frame: At Week 48

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Remission at Week 48

Time frame: At Week 48

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48

Time frame: At Week 48

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12

Time frame: At Week 12

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48

Time frame: At Week 48

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48

Time frame: At Week 48

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48

Time frame: At Week 48

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12

Time frame: At Week 12

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12

Time frame: At Week 12

Secondary

Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48

Time frame: At Week 48

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026