A Study of the Efficacy and Safety of Guselkumab in Parti... | NCT03466411 | Trialant
NCT03466411
Sponsor
Janssen Research & Development, LLC
Status
Active, not recruiting
Last Update Posted
Jul 6, 2026Actual
Enrollment
1,409Actual
Phase
Phase 2Phase 3
Conditions
Crohn's Disease
Interventions
Guselkumab Dose 1
Guselkumab Dose 2
Guselkumab Dose 3
Guselkumab Dose 4
Guselkumab Dose 5
Guselkumab
Ustekinumab
Placebo
Countries
United States
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
Protocol Section
Identification Module
NCT ID
NCT03466411
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108387
Secondary IDs
ID
Type
Description
Link
CNTO1959CRD3001
Other Identifier
Janssen Research & Development, LLC
2017-002195-13
EudraCT Number
2023-504736-18-00
Registry Identifier
EUCT number
Brief Title
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Official Title
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
Acronym
GALAXI
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Jul 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 13, 2018Actual
Primary Completion Date
Oct 20, 2023Actual
Completion Date
Jan 28, 2028Estimated
First Submitted Date
Mar 8, 2018
First Submission Date that Met QC Criteria
Mar 8, 2018
First Posted Date
Mar 15, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Apr 17, 2025
Results First Submitted that Met QC Criteria
Apr 17, 2025
Results First Posted Date
May 7, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 15, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Oct 16, 2024Actual
Last Update Submitted Date
Jul 2, 2026
Last Update Posted Date
Jul 6, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Crohn's Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,409Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 2 (GALAXI 1): Group 1 (Guselkumab)
Experimental
Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab.
Drug: Guselkumab Dose 1
Drug: Guselkumab Dose 2
Phase 2 (GALAXI 1): Group 2 (Guselkumab)
Experimental
Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.
Drug: Guselkumab Dose 2
Drug: Guselkumab Dose 3
Phase 2 (GALAXI 1): Group 3 (Guselkumab)
Experimental
Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.
Drug: Guselkumab Dose 4
Drug: Guselkumab Dose 5
Phase 2 (GALAXI 1): Group 4 (Ustekinumab)
Active Comparator
Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE and continue to receive ustekinumab.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Guselkumab Dose 1
Drug
Guselkumab will be administered by IV infusion.
Phase 2 (GALAXI 1): Group 1 (Guselkumab)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Baseline and Week 12
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.
Weeks 48
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.
Secondary Outcomes
Measure
Description
Time Frame
GALAXI 1: Percentage of Participants With Clinical Remission at Week 12
At Week 12
GALAXI 1: Percentage of Participants With Clinical Response at Week 12
At Week 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
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.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w
Participants received guselkumab 1200 milligrams (mg) intravenous (IV) infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg subcutaneous (SC) injection every 4 weeks (q4w) as maintenance dose from Week 12 through Week 44.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 12, 2022
Apr 17, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Chile
Ireland
Norway
Slovenia
South Africa
Sweden
Switzerland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Ustekinumab
Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)
Experimental
Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.
Drug: Ustekinumab
Drug: Placebo
Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
Experimental
Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.
Drug: Guselkumab
Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)
Active Comparator
Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE phase and continue to receive ustekinumab.
Drug: Ustekinumab
Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
Experimental
Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.
Drug: Ustekinumab
Drug: Placebo
Guselkumab Dose 2
Drug
Guselkumab will be administered by SC injection.
Phase 2 (GALAXI 1): Group 1 (Guselkumab)
Phase 2 (GALAXI 1): Group 2 (Guselkumab)
Guselkumab Dose 3
Drug
Guselkumab will be administered by IV infusion.
Phase 2 (GALAXI 1): Group 2 (Guselkumab)
Guselkumab Dose 4
Drug
Guselkumab will be administered by IV infusion.
Phase 2 (GALAXI 1): Group 3 (Guselkumab)
Guselkumab Dose 5
Drug
Guselkumab will be by SC injection.
Phase 2 (GALAXI 1): Group 3 (Guselkumab)
Guselkumab
Drug
Guselkumab will be administered by IV infusion and SC injection.
Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
Ustekinumab
Drug
Ustekinumab will be administered by IV infusion and SC injection.
Phase 2 (GALAXI 1): Group 4 (Ustekinumab)
Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)
Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)
Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
Placebo
Drug
Placebo will be administered as IV infusion.
Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)
Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
Weeks 48
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.
Weeks 48
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.
Weeks 48
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.
Week 12
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.
Week 12
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.
Week 12
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.
Week 12
GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12
At Week 12
GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12
At Week 12
GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12
At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4
At Week 4
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12
At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12
At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12
At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12
At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12
At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48
At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Endoscopic Remission at Week 48
At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48
At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48
At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48
At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48
At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12
At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12
At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12
At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48
At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48
At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48
At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48
At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48
At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission at Week 48 and Endoscopic Response at Week 48
At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Remission at Week 48
At Week 48
Mobile
Alabama
36693
United States
University of Arizona
Tucson
Arizona
85724
United States
Advanced Research Center Inc
Anaheim
California
92805
United States
Paul Wallace MD
Beverly Hills
California
90211
United States
University Of California San Diego
La Jolla
California
92093
United States
Om Research LLC
Lancaster
California
93534
United States
Allameh Medical Corp
Mission Viejo
California
92691
United States
United Gastroenterologists
Murrieta
California
92563
United States
Clinnova Research
Orange
California
92868
United States
Inland Empire Liver Foundation
Rialto
California
91106
United States
UC Davis Medical Center
Sacramento
California
95817
United States
Clinical Applications Laboratories, Inc
San Diego
California
91941
United States
Peak Gastroenterology Associates
Colorado Springs
Colorado
80920
United States
Pioneer Research Solutions Inc.
Coconut Creek
Florida
33066
United States
InvesClinic, LLC
Fort Lauderdale
Florida
33308
United States
Harmony Medical Research Institute, Inc.
Hialeah
Florida
33016
United States
Elite Research Network - Nature Coast Clinical Research, LLC
Inverness
Florida
34452
United States
SIH Research
Kissimmee
Florida
34759
United States
Auzmer Research
Lakeland
Florida
33813
United States
Florida Research Center Inc.
Lakewood Rch
Florida
34211
United States
Homestead Associates in Research Inc
Miami
Florida
33032
United States
Community Research Foundation, Inc.
Miami
Florida
33155
United States
Sanchez Clinical Research, Inc
Miami
Florida
33157-6575
United States
Visionary Investigators Network
Miami
Florida
33180
United States
Gastroenterology Group Of Naples
Naples
Florida
34102
United States
Florida Hospital
Orlando
Florida
32803
United States
Omega Research Consultants
Orlando
Florida
32808
United States
Care Access Research, Orlando
Orlando
Florida
32825
United States
Synexus Clinical Research US Inc 1
Pinellas Park
Florida
33781
United States
Central Florida Internists
Saint Cloud
Florida
34769
United States
Synergy Clinical Research
St. Petersburg
Florida
33705
United States
Theia Clincial Research, LLC
St. Petersburg
Florida
33709
United States
Clinical Research of West Florida
Tampa
Florida
33603
United States
GCP Clinical Research
Tampa
Florida
33609
United States
Florida Hospital Tampa
Tampa
Florida
33613
United States
Cleveland Clinic Florida
Weston
Florida
33331
United States
Atlanta Gastroenterology Associates
Atlanta
Georgia
30224
United States
Morehouse School of Medicine
Atlanta
Georgia
30310
United States
Emory University
Atlanta
Georgia
30322
United States
Atlanta Center For Gastroenterology
Decatur
Georgia
30033
United States
Gastroenterology Consultants
Roswell
Georgia
30076
United States
Atlanta Gastroenterology Specialists PC
Suwanee
Georgia
30024
United States
Carle Foundation Hospital
Urbana
Illinois
61801
United States
IU Health University Hospital
Indianapolis
Indiana
46202
United States
BVL Clinical Research
Leawood
Kansas
66211
United States
Health Science Research Center
Pratt
Kansas
67124
United States
Cotton O'Neil Digestive Health Center
Topeka
Kansas
66606
United States
Gastroenterology Associates
Baton Rouge
Louisiana
70809
United States
Gastroenterology Clinic of Acadiana
Lafayette
Louisiana
70503
United States
Tandem Clinical Research
Marrero
Louisiana
70072
United States
Ochsner Clinic Foundation
New Orleans
Louisiana
70121
United States
DelRicht Research
New Orleans
Louisiana
70124
United States
LSUHSC Shreveport Feist-Weiller Cancer Center
Shreveport
Louisiana
71103
United States
Louisiana Research Center, LLC
Shreveport
Louisiana
71105
United States
Woodholme Gastroenterology Associates
Baltimore
Maryland
21208
United States
Digestive Health Specialists PC
Chelmsford
Massachusetts
01824
United States
Clinical Research Institute of Michigan, LLC
Chesterfield
Michigan
48047
United States
Huron Gastroenterology Associates Center for Digestive Care
Ypsilanti
Michigan
48197
United States
Las Vegas Medical Research
Las Vegas
Nevada
89113
United States
Atlantic Digestive Health Institute/ Atlantic IBD Center
Morristown
New Jersey
07960
United States
A1 Clinical Research
Jackson Heights
New York
11372
United States
Weill Cornell Medical College
New York
New York
10021
United States
New York Gastroenterology Associates
New York
New York
10028
United States
Care Access Research
New York
New York
10065
United States
NYU Langone Medical Center
New York
New York
11021
United States
University of Rochester Medical Center
Rochester
New York
14642
United States
Syracuse VA Medical Center
Syracuse
New York
13210
United States
Asheville Gastroenterology Associates
Asheville
North Carolina
28801
United States
University North Carolina at Chapel Hill
Chapel Hill
North Carolina
27599
United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte
North Carolina
28207
United States
Onsite Clinical Solutions
Charlotte
North Carolina
28277
United States
Cumberland Research Associates
Fayetteville
North Carolina
28304
United States
Care Access Research, Kinston
Kinston
North Carolina
28501
United States
Clinical Trials of America
Mount Airy
North Carolina
27030
United States
PMG Research of Winston-Salem
Winston-Salem
North Carolina
27103
United States
Clinical Inquest Center, LTD
Beavercreek
Ohio
45432
United States
Ohio State University
Columbus
Ohio
43210
United States
Synexus Clinical Research US Inc 2
Columbus
Ohio
43212
United States
Great Lakes Gastroenterology Research, LLC
Mentor
Ohio
44060
United States
Southwoods Health
Poland
Ohio
44514
United States
Northshore Gastroenterology Research, LLC
Westlake
Ohio
44145
United States
Integris Baptist Office
Oklahoma City
Oklahoma
73112
United States
US Digestive Health
Wyomissing
Pennsylvania
19610
United States
Synexus Clinical Research US Inc
Anderson
South Carolina
29621-2062
United States
Gastroenterology Associates P.A.
Greenville
South Carolina
29615
United States
Memorial Health Care System
Chattanooga
Tennessee
37404
United States
Gastro One
Germantown
Tennessee
38138
United States
Tennessee State University
Johnson
Tennessee
37614-1700
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37212-1610
United States
DHAT Research Institute
Garland
Texas
75044
United States
Baylor College of Medicine
Houston
Texas
77030
United States
Houston Methodist Hospital
Houston
Texas
77030
United States
Houston Digestive Diseases Consultants
Houston
Texas
77074
United States
CliniCore Houston
Houston
Texas
77079
United States
Caprock Gastro Research
Lubbock
Texas
79424
United States
Gastroenterology Clinic Of San Antonio P A
San Antonio
Texas
78229
United States
Gastroenterology Research of America, LLC
San Antonio
Texas
78229
United States
UT Health Science Center at San Antonio
San Antonio
Texas
78229
United States
Texas Digestive Disease Consultants
Southlake
Texas
76092
United States
Texas Gastroenterology Associates - Research
Spring
Texas
77386
United States
Baylor Scott and White Research Institute
Temple
Texas
76508
United States
Tyler Research Institute, LLC
Tyler
Texas
75701
United States
Gastroenterology Associates of Tidewater
Chesapeake
Virginia
23320
United States
Center for Gastrointestinal Health
Petersburg
Virginia
23805
United States
Gastroenterology Consultants of Southwest Virginia
Roanoke
Virginia
24014-1372
United States
Northwest Gastroenterology Associates - USA
Bellevue
Washington
98004
United States
Washington Gastroenterology, PLLC
Tacoma
Washington
98405
United States
The Queen Elizabeth Hospital
Adelaide
5011
Australia
Monash Health, Monash Medical Centre
Clayton
3168
Australia
Concord Hospital
Concord
2139
Australia
Austin Hospital
Heidelberg
3084
Australia
Sir Charles Gairdner Hospital
Nedlands
6009
Australia
Royal Adelaide Hospital
North Terrace
5000
Australia
Royal Melbourne Hospital
Parkville
3050
Australia
Nepean Hospital
Penrith
2751
Australia
The Alfred Hospital
Prahran
3004
Australia
Mater Hospital Brisbane
South Brisbane
4101
Australia
Princess Alexandra Hospital
Woolloongabba
4102
Australia
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg
5020
Austria
Akh Wien
Vienna
1090
Austria
Grodno University Hospital
Grodno
230017
Belarus
Gomel Regional Clinical Hospital
Homyel
246029
Belarus
Republican Research Centre of Radiation Medicine and Human E
Homyel
246040
Belarus
Healthcare Institution,Minsk Scientific center for surgery,
Minsk
220116
Belarus
Vitebsk Regional Clinical Hospital
Vitebsk
210037
Belarus
AZ Klina
Brasschaat
2930
Belgium
CHU Saint-Pierre
Brussels
1000
Belgium
Hopital Erasme
Brussels
1070
Belgium
UZ Gent
Ghent
9000
Belgium
Az Groeninge
Kortrijk
8500
Belgium
Algemeen Ziekenhuis Delta
Roeselare
8800
Belgium
CHwapi
Tournai
7500
Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka
78000
Bosnia and Herzegovina
Clinical hospital Mostar
Mostar
88000
Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo
71000
Bosnia and Herzegovina
Polyclinic Dr. Al-Tawil
Sarajevo
71000
Bosnia and Herzegovina
Cantonal Hospital Zenica
Zenica
72000
Bosnia and Herzegovina
MK Blumenau Pesquisa Clínica
Blumenau
89010-506
Brazil
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu
18618-970
Brazil
L2IP Instituto de Pesquisas Clinicas
Brasília
70200 730
Brazil
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas
13060-904
Brazil
Hospital Nossa Senhora Das Gracas
Curitiba
80810-040
Brazil
Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
Goiânia
74535-170
Brazil
Centro de Estudos Clínicos do Interior Paulista - CECIP
Jaú
17201-130
Brazil
CMIP - Centro Mineiro de Pesquisa Ltda
Juiz de Fora
36010 570
Brazil
Complexo Hospitalar de Niteroi
Niterói
24020-096
Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo
99010-120
Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre
90035-903
Brazil
Instituto do Aparelho Digestivo
Porto Alegre
90560-002
Brazil
Universidade Federal do Rio de Janeiro - Faculdade de Medicina
Rio de Janeiro
21941-913
Brazil
Hospital Santa Izabel
Salvador
40050-410
Brazil
Pesquisare Saude
Santo André
09080-110
Brazil
Praxis pesquisa médica
Santo André
09090-790
Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
Santo André
09190-510
Brazil
Irmandade da Santa Casa da Misericórdia de Santos
Santos São Paulo
11075-101
Brazil
Kaiser Hospta
São José do Rio Preto
15015-110
Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto
15090-000
Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo
01228-200
Brazil
Hemomed
São Paulo
01236-030
Brazil
BR Trials
São Paulo
03325-050
Brazil
Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
Teresina
64049-550
Brazil
University of Calgary
Calgary
Alberta
T2N4Z6
Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton
Alberta
T5R 1W2
Canada
University of Alberta- Ziedler Ledcor Centre
Edmonton
Alberta
T6G 2X8
Canada
Columbia Gastroenterology
New Westminster
British Columbia
Canada
Health Sciences Centre
Winnipeg
Manitoba
R3A1R9
Canada
Barrie GI Associates
Barrie
Ontario
L4M 7G1
Canada
London Health Sciences Centre
London
Ontario
N6A 5A5
Canada
Mount Sinai Hospital-Toronto
Toronto
Ontario
M5G 1X5
Canada
Pharmaceutical Integrated Research Company
Waterloo
Ontario
N2J 1C4
Canada
MUHC Montreal General Hospital
Montreal
Quebec
H3H2R9
Canada
Royal University Hospital
Saskatoon
Saskatchewan
S7N 0W8
Canada
Peking University First Hospital
Beijing
100034
China
Beijing Friendship Hospital
Beijing
100050
China
Peking University Third Hospital
Beijing
100191
China
The Military General Hospital of Beijing PLA
Beijing
100700
China
The second Xiangya Hospital of Central South University
Changsha
200120
China
Changzhou No 2 Peoples Hospital
Changzhou
213004
China
West China Hospital Sichuan University
Chengdu
610041
China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
400010
China
First Affiliated Hospital of Gannan Medical University
Ganzhou
341000
China
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou
510080
China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou
510235
China
ZhuJiang Hospital of Southern Medical University
Guangzhou
510280
China
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
Guangzhou
510610
China
The Second Affiliated Hospital of Zhejiang University
Hangzhou
310003
China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou
310016
China
The First Affiliated Hospital of Anhui Medical University
Hefei
230022
China
Huai'an 1st Hospital
Huai'an
China
The First Affiliated Hospital of NanChang University
Nanchang
330006
China
Nanjing Drum Tower Hospital
Nanjing
210008
China
Zhongda Hospital Southeast University
Nanjing
210009
China
Shanghai Ninth Peoples Hospital
Shanghai
200011
China
Huashan Hospital Fudan University
Shanghai
200040
China
Second Military Medical University (SMMU)
Shanghai
200433
China
Tongji Hospital of Tongji University
Shanghai
430030
China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai
China
Shengjing Hospital Of China Medical University
Shenyang
110004
China
Peking University Shenzhen Hospital
Shenzhen
518036
China
The first affiliated hospital of suzhou University
Suzhou
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
325003
China
Wuhan Union Hospital
Wuhan
430022
China
Renmin Hospital of Wuhan University
Wuhan
430060
China
Wuxi People s Hospital
Wuxi
214023
China
Zhongshan Hospital, Xiamen University
Xiamen
361004
China
Yangzhou First People's Hospital
Yangzhou
225001
China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou
363000
China
Medplus Medicina Prepagada S.A.
Bogotá
110111
Colombia
Clinica de la Mujer
Bogotá
110221
Colombia
Endocare Ltda.
Bogotá
111111
Colombia
Centro Médico Imbanaco
Cali
760042
Colombia
Corporacion para Estudios en Salud Clinica CES - Gastroenterology
Medellín
50012
Colombia
Opca bolnica Bjelovar
Bjelovar
43000
Croatia
Opca bolnica Zadar
Zadar
23000
Croatia
CH Sestre Milosrdnice
Zagreb
10000
Croatia
Poliklinika Solmed
Zagreb
10000
Croatia
University Hospital Center Zagreb
Zagreb
10000
Croatia
University Hospital Dubrava
Zagreb
10000
Croatia
Nemocnice Ceske Budejovice
České Budějovice
370 01
Czechia
NH Hospital, a.s.
Hořovice
268 31
Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové
500 12
Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague
100 34
Czechia
Synexus Czech s.r.o.
Prague
120 00
Czechia
ISCARE a.s.
Prague
190 00
Czechia
CHU Amiens
Amiens
80054
France
Centre Hospitalier de la Cote Basque
Bayonne
64100
France
CHRU Besancon Hopital Jean Minjoz
Besançon
25000
France
Centre Hospitalier Universitaire (CHU) de Caen
Caen
14033
France
CHRU de Tours - Hopital Trousseau
Chambray Les Tours Centre
37170
France
Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
Créteil
94010
France
CHU Grenoble
Grenoble
38700
France
CHRU de Lille Hopital Claude Huriez
Lille
59037
France
Hopital Nord Marseille
Marseille
13915
France
CHRU Montpellier - Hopital Saint-Eloi
Montpellier
34295
France
CHU de Nantes hotel Dieu
Nantes
44093
France
CHU de Nice Hopital de l Archet
Nice
06202
France
CHU Nimes Hopital Caremeau
Nîmes
30029
France
Hôpital Bichat
Paris
75877
France
Groupement Hospitalier Universitaire Ouest
Paris
75908
France
Centre Hospitalier Lyon Sud
Pierre-Bénite
69495
France
Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré
Reims
51092
France
CHU Saint Etienne
Saint-Etienne
42270
France
Hopital D'Instruction Des Armees
Saint-Mandé
94160
France
CHRU de Strasbourg - Hopital de Hautepierre
Strasbourg
67098
France
CHU Toulouse - Hopital de Rangueil
Toulouse
31059
France
Hopital Rangueil
Toulouse
50032
France
CHU de Nancy_ Hopital Brabois
Vandœuvre-lès-Nancy
54511
France
TSMU The First University Clinic
Tbilisi
0141
Georgia
Institute of Clinical Cardiology, Ltd.
Tbilisi
0159
Georgia
LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital'
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
Kyiv
03037
Ukraine
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv
03049
Ukraine
Kyiv Regional Clinical Hospital
Kyiv
4107
Ukraine
Odeska oblasna klinichna likarnia
Odesa
65025
Ukraine
Ternopil municipal hospital #1
Ternopil
46000
Ukraine
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
Uzhhorod
88018
Ukraine
Health Clinic Limited Liability Company
Vinnytsia
21009
Ukraine
KU 6 miska klinichna likarnia ZMR
Zaporizhzhya
69035
Ukraine
Barnsley District General Hospital
Barnsley
S75 2EP
United Kingdom
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
St Georges Healthcare NHS Trust
London
SW17 0QT
United Kingdom
Derived
Panaccione R, Feagan BG, Afzali A, Rubin DT, Reinisch W, Panes J, Danese S, Hisamatsu T, Terry NA, Salese L, Van Rampelbergh R, Sahoo A, Vetter ML, Yee J, Han C, Frustaci ME, Wan KYY, Yang Z, Johanns J, Andrews JM, D'Haens GR, Sands BE; GALAXI 2 & 3 Study Group. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025 Jul 26;406(10501):358-375. doi: 10.1016/S0140-6736(25)00681-6. Epub 2025 Jul 17.
Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
Danese S, Panaccione R, Feagan BG, Afzali A, Rubin DT, Sands BE, Reinisch W, Panes J, Sahoo A, Terry NA, Chan D, Han C, Frustaci ME, Yang Z, Sandborn WJ, Hisamatsu T, Andrews JM, D'Haens GR; GALAXI-1 Study Group. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):133-146. doi: 10.1016/S2468-1253(23)00318-7. Epub 2023 Dec 14.
Sandborn WJ, D'Haens GR, Reinisch W, Panes J, Chan D, Gonzalez S, Weisel K, Germinaro M, Frustaci ME, Yang Z, Adedokun OJ, Han C, Panaccione R, Hisamatsu T, Danese S, Rubin DT, Sands BE, Afzali A, Andrews JM, Feagan BG; GALAXI-1 Investigators. Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study. Gastroenterology. 2022 May;162(6):1650-1664.e8. doi: 10.1053/j.gastro.2022.01.047. Epub 2022 Feb 5.
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.
FG002
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 every 8 weeks (q8w) as maintenance dose from Week 16 through Week 40.
FG003
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 milligrams per kilogram (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.
FG004
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 clinical response (CR) (decrease from baseline in Crohn's Disease Activity Index [CDAI] score of greater than or equal to [>=] 100 points or CDAI score less than [<] 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.
FG005
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.
FG006
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.
FG007
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.
FG008
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.
FG009
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.
FG010
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.
FG011
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.
FG012
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.
FG00073 subjects
FG00173 subjects
FG00273 subjects
FG00371 subjects
FG00470 subjects
FG005148 subjects
FG006149 subjects
FG007150 subjects
FG00877 subjects
FG009151 subjects
FG010148 subjects
FG011150 subjects
FG01276 subjects
Participants Who Did Not Achieve CR at Week 12 and Crossed Over to Ustekinumab
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00443 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00849 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG01251 subjects
COMPLETED
FG00058 subjects
FG00164 subjects
FG00264 subjects
FG00366 subjects
FG00462 subjects
FG005145 subjects
FG006141 subjects
FG007140 subjects
FG00871 subjects
FG009138 subjects
FG010131 subjects
FG011137 subjects
FG01269 subjects
NOT COMPLETED
FG00015 subjects
FG0019 subjects
FG0029 subjects
FG0035 subjects
FG0048 subjects
FG0053 subjects
FG0068 subjects
FG00710 subjects
FG0086 subjects
FG00913 subjects
FG01017 subjects
FG01113 subjects
FG0127 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
Withdrawal by Subject
FG00014 subjects
FG0017 subjects
FG0028 subjects
FG0034 subjects
FG004
Other
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Randomized but not Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline characteristics data were presented for all randomized participants who received at least 1 dose of study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
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.
BG008
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.
BG009
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.
BG010
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.
BG011
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.
BG012
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.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00073
BG00173
BG00273
BG00371
BG00470
BG005148
BG006148
BG007150
BG00877
BG009151
BG010148
BG011150
BG01276
BG0131408
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00040.2± 14.28
BG00139.3± 15.51
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00035
BG00129
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Australia
Title
Measurements
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
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.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 12
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w
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.
Units
Counts
Participants
OG00058
OG00162
OG00260
OG003
Title
Denominators
Categories
Title
Measurements
OG000-143.7± 96.58
OG001-139.2± 100.71
OG002-159.8± 110.52
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
Mixed Model for Repeated Measure
<0.001
Least Square (LS) Mean Difference
124.2
2-Sided
95
89.8
158.7
LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.
Superiority
OG001
OG003
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.
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.
Posted
Number
Percentage of participants
Weeks 48
ID
Title
Description
OG000
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.
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.
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.
Posted
Number
Percentage of participants
Weeks 48
ID
Title
Description
OG000
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.
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.
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.
Posted
Number
Percentage of participants
Weeks 48
ID
Title
Description
OG000
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.
OG001
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.
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.
Posted
Number
Percentage of participants
Weeks 48
ID
Title
Description
OG000
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.
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.
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.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
GALAXI 2 Placebo (From Group 4)
Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8.
OG001
GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2)
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.
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.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
GALAXI 2 Placebo (From Group 4)
Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8.
OG001
GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2)
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.
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.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
GALAXI 3 Placebo (From Group 4)
Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8.
OG001
GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2)
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.
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.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
GALAXI 3 Placebo (From Group 4)
Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8.
OG001
GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2)
Secondary
GALAXI 1: Percentage of Participants With Clinical Remission at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
GALAXI 1: Percentage of Participants With Clinical Response at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4
Not Posted
Jun 2031
At Week 4
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Endoscopic Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Global: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12
Not Posted
Jun 2031
At Week 12
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission at Week 48 and Endoscopic Response at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Secondary
Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Remission at Week 48
Not Posted
Jun 2031
At Week 48
Participants
Time Frame
From Week 0 up to Week 48
Description
All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 & 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w
Participants received guselkumab 1200 milligrams (mg) intravenous (IV) infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg subcutaneous (SC) injection every 4 weeks (q4w) as maintenance dose from Week 12 through Week 44.
0
73
5
73
33
73
EG001
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.
0
73
5
73
34
73
EG002
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.
0
73
6
73
34
73
EG003
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.
0
71
9
71
44
71
EG004
GALAXI 1 (Group 5) Placebo q4w
Participants randomized to receive placebo IV infusion q4w, excluding data after participant crossed over to ustekinumab.
0
70
6
70
27
70
EG005
GALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Participants randomized to receive placebo IV infusion q4w who crossed over to ustekinumab. Data in this group occurred after a participant crossed over to ustekinumab.
0
43
0
43
16
43
EG006
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.
0
148
6
148
80
148
EG007
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.
0
149
19
148
66
148
EG008
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.
0
150
18
150
78
150
EG009
GALAXI 2 (Group 4) Placebo q4w
Participants randomized to receive placebo IV infusion q4w, excluding data after participant crossed over to ustekinumab.
0
77
6
77
21
77
EG010
GALAXI 2 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Participants randomized to receive placebo IV infusion q4w who crossed over to ustekinumab. Data in this group occurred after a participant crossed over to ustekinumab.
0
49
3
49
15
49
EG011
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.
0
151
15
151
80
151
EG012
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.
0
148
13
148
69
148
EG013
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.
0
150
17
150
73
150
EG014
GALAXI 3 (Group 4) Placebo q4w
Participants randomized to receive placebo IV infusion q4w, excluding data after participant crossed over to ustekinumab.
0
76
10
76
30
76
EG015
GALAXI 3 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Participants randomized to receive placebo IV infusion q4w who crossed over to ustekinumab. Data in this group occurred after a participant crossed over to ustekinumab.
0
51
6
51
19
51
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected73 at risk
EG0030 affected71 at risk
EG0041 affected70 at risk
EG0050 affected43 at risk
EG0060 affected148 at risk
EG0070 affected148 at risk
EG0082 affected150 at risk
EG0090 affected77 at risk
EG0100 affected49 at risk
EG0110 affected151 at risk
EG0120 affected148 at risk
EG0131 affected150 at risk
EG0140 affected76 at risk
EG0150 affected51 at risk
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Anal Fistula
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Aphthous Ulcer
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Crohn's Disease
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Enterovesical Fistula
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected73 at risk
EG003
Frequent Bowel Movements
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Gastrointestinal Tract Irritation
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected73 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Ileal Stenosis
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected73 at risk
EG003
Inflammatory Bowel Disease
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Intestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Intestinal Perforation
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Intestinal Stenosis
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Large Intestinal Stenosis
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Large Intestine Perforation
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected73 at risk
EG003
Small Intestinal Perforation
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Small Intestinal Stenosis
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Bile Duct Stone
Hepatobiliary disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Drug-Induced Liver Injury
Hepatobiliary disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Hepatitis Toxic
Hepatobiliary disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Abdominal Abscess
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Abdominal Infection
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Abdominal Sepsis
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Abscess Intestinal
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Abscess Limb
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Acute Sinusitis
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0022 affected73 at risk
EG003
Bacterial Infection
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Covid-19 Pneumonia
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Device Related Bacteraemia
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Enterocolitis Infectious
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Epididymitis
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected73 at risk
EG003
Intestinal Fistula Infection
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Liver Abscess
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Pelvic Abscess
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Post Procedural Infection
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Testicular Abscess
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Vascular Device Infection
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Clavicle Fracture
Injury, poisoning and procedural complications
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Procedural Intestinal Perforation
Injury, poisoning and procedural complications
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Skull Fracture
Injury, poisoning and procedural complications
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected73 at risk
EG003
Traumatic Haematoma
Injury, poisoning and procedural complications
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Liver Function Test Increased
Investigations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Calcium Deficiency
Metabolism and nutrition disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Arthritis Enteropathic
Musculoskeletal and connective tissue disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Foot Deformity
Musculoskeletal and connective tissue disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected73 at risk
EG003
Desmoid Tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0021 affected73 at risk
EG003
Follicular Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Gastrointestinal Tract Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Lumbar Radiculopathy
Nervous system disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Wernicke's Encephalopathy
Nervous system disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected73 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Adjustment Disorder
Psychiatric disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Adjustment Disorder with Depressed Mood
Psychiatric disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Depression Suicidal
Psychiatric disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Calculus Urinary
Renal and urinary disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Ovarian Cyst Ruptured
Reproductive system and breast disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Uterine Polyp
Reproductive system and breast disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0001 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Miscarriage of Partner
Social circumstances
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0011 affected73 at risk
EG0020 affected73 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0003 affected73 at risk
EG0016 affected73 at risk
EG0021 affected73 at risk
EG0037 affected71 at risk
EG0044 affected70 at risk
EG0051 affected43 at risk
EG00610 affected148 at risk
EG0078 affected148 at risk
EG00811 affected150 at risk
EG0093 affected77 at risk
EG0101 affected49 at risk
EG0115 affected151 at risk
EG0127 affected148 at risk
EG0135 affected150 at risk
EG0145 affected76 at risk
EG0153 affected51 at risk
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0002 affected73 at risk
EG0012 affected73 at risk
EG0021 affected73 at risk
EG003
Crohn's Disease
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0004 affected73 at risk
EG0015 affected73 at risk
EG0026 affected73 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0004 affected73 at risk
EG0011 affected73 at risk
EG0024 affected73 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0002 affected73 at risk
EG0012 affected73 at risk
EG0023 affected73 at risk
EG003
Pyrexia
General disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0004 affected73 at risk
EG0013 affected73 at risk
EG0026 affected73 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0000 affected73 at risk
EG0010 affected73 at risk
EG0020 affected73 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0008 affected73 at risk
EG0019 affected73 at risk
EG0028 affected73 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 26.0
Non-systematic Assessment
EG0004 affected73 at risk
EG0016 affected73 at risk
EG0022 affected73 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 26.0
Non-systematic Assessment
EG0002 affected73 at risk
EG0011 affected73 at risk
EG0025 affected73 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA Version 26.0
Non-systematic Assessment
EG0003 affected73 at risk
EG0012 affected73 at risk
EG0021 affected73 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0004 affected73 at risk
EG0014 affected73 at risk
EG0028 affected73 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0004 affected73 at risk
EG0015 affected73 at risk
EG0023 affected73 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 26.0
Non-systematic Assessment
EG0007 affected73 at risk
EG00110 affected73 at risk
EG0025 affected73 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.
Superiority
OG000
OG003
Mixed Model for Repeated Measure
<0.001
LS Mean Difference
108.7
2-Sided
95
73.9
143.5
LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.
Superiority
OG001
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.
OG002
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.
Units
Counts
Participants
OG000146
OG001143
OG00276
Title
Denominators
Categories
Title
Measurements
OG00054.8
OG00149.0
OG00211.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Mantel Haenszel
<0.001
Adjusted treatment difference
38.1
2-Sided
95
27.3
48.9
Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.
Superiority
OG000
OG002
Mantel Haenszel
<0.001
Adjusted treatment difference
42.8
2-Sided
95
31.6
53.9
Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.
Superiority
OG001
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.
OG002
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.
Units
Counts
Participants
OG000146
OG001143
OG00276
Title
Denominators
Categories
Title
Measurements
OG00038.4
OG00139.2
OG0025.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Mantel Haenszel
<0.001
Adjusted treatment difference
33.7
2-Sided
95
24.1
43.2
Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.
Superiority
OG000
OG002
Mantel Haenszel
<0.001
Adjusted treatment difference
32.9
2-Sided
95
23.5
42.4
Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.
Superiority
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.
OG002
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.
Units
Counts
Participants
OG000150
OG001143
OG00272
Title
Denominators
Categories
Title
Measurements
OG00048.0
OG00146.9
OG00212.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Mantel Haenszel
<0.001
Adjusted treatment difference
34.2
2-Sided
95
23.2
45.3
Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.
Superiority
OG000
OG002
Mantel Haenszel
<0.001
Adjusted treatment difference
35
2-Sided
95
23.5
46.5
Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.
Superiority
OG001
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.
OG002
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.
Units
Counts
Participants
OG000150
OG001143
OG00272
Title
Denominators
Categories
Title
Measurements
OG00036.0
OG00133.6
OG0025.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Mantel Haenszel
<0.001
Adjusted treatment difference
27.9
2-Sided
95
18.7
37.1
Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.
Superiority
OG000
OG002
Mantel Haenszel
<0.001
Adjusted treatment difference
30.8
2-Sided
95
21.3
40.3
Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.
Superiority
Participants received guselkumab 200 mg IV infusion at Weeks 0, 4, and 8.
Units
Counts
Participants
OG00076
OG001289
Title
Denominators
Categories
Title
Measurements
OG00022.4
OG00147.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mantel Haenszel
<0.001
Adjusted treatment difference
25.1
2-Sided
95
14.1
36.2
Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.
Superiority
Participants received guselkumab 200 mg IV infusion at Weeks 0, 4, and 8.
Units
Counts
Participants
OG00076
OG001289
Title
Denominators
Categories
Title
Measurements
OG00010.5
OG00137.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mantel Haenszel
<0.001
Adjusted treatment difference
27.7
2-Sided
95
19.3
36.1
Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.
Superiority
Participants received guselkumab 200 mg IV infusion at Weeks 0, 4, and 8.
Units
Counts
Participants
OG00072
OG001293
Title
Denominators
Categories
Title
Measurements
OG00015.3
OG00147.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mantel Haenszel
<0.001
Adjusted treatment difference
31.2
2-Sided
95
21.1
41.3
Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.
Superiority
Participants received guselkumab 200 mg IV infusion at Weeks 0, 4, and 8.
Units
Counts
Participants
OG00072
OG001293
Title
Denominators
Categories
Title
Measurements
OG00013.9
OG00136.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mantel Haenszel
<0.001
Adjusted treatment difference
22.1
2-Sided
95
12.2
31.9
Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.