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Active, not recruitingNCT03466411GALAXIUpdated Nov 3, 2026Results posted

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

A Phase 2/3 interventional study of Guselkumab Dose 1 and Guselkumab Dose 2 in Crohn's Disease, sponsored by Janssen Research & Development, LLC. Active, not recruiting at 579 sites in 43 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2/3, Interventional, and Treatment

Updated Nov 3, 20261 site added1 site removedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
1,409
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Crohn's Disease

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03

In context

Crohn Disease

1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.

This study's enrollment of 1,409 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.

Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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, agents, or procedures outside of permitted timeframe as specified in the protocol
  • Any medical preventing study participation
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,409 participants (actual)

Study arms

  • Experimental
    Phase 2 (GALAXI 1): Group 1 (Guselkumab)

    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

  • Experimental
    Phase 2 (GALAXI 1): Group 2 (Guselkumab)

    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

  • Experimental
    Phase 2 (GALAXI 1): Group 3 (Guselkumab)

    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

  • Active comparator
    Phase 2 (GALAXI 1): Group 4 (Ustekinumab)

    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.

    Drug: Ustekinumab

  • Experimental
    Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)

    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

  • Experimental
    Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)

    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

  • Active comparator
    Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)

    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

  • Experimental
    Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)

    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

Interventions

  • DrugGuselkumab Dose 1

    Guselkumab will be administered by IV infusion.

  • DrugGuselkumab Dose 2

    Guselkumab will be administered by SC injection.

  • DrugGuselkumab Dose 3

    Guselkumab will be administered by IV infusion.

  • DrugGuselkumab Dose 4

    Guselkumab will be administered by IV infusion.

  • DrugGuselkumab Dose 5

    Guselkumab will be by SC injection.

  • DrugGuselkumab

    Guselkumab will be administered by IV infusion and SC injection.

  • DrugUstekinumab

    Ustekinumab will be administered by IV infusion and SC injection.

  • DrugPlacebo

    Placebo will be administered as IV infusion.

06

What researchers measure

Primary outcomes

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

    The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity. Baseline was defined as the last observation prior to or at the date of the first study intervention.

    Time frame: Baseline and Week 12

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

    Clinical response was defined as a decrease from baseline (BL) in CDAI score greater than or equal to (\>=) 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Time frame: Weeks 48

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

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

    Time frame: Weeks 48

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

    Clinical response was defined as a decrease from baseline in CDAI score \>= 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Time frame: Weeks 48

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

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

    Time frame: Weeks 48

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

    Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Time frame: Week 12

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

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

    Time frame: Week 12

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

    Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Time frame: Week 12

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

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

    Time frame: Week 12

Secondary outcomes

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 4

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 12

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

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

    Time frame: At Week 48

07

Results

Posted May 7, 2025

Participant flow

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.

Participant flow — Overall Study
MilestoneGALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Started73737371701481491507715114815076
Participants who did not achieve cr at week 12 and crossed over to ustekinumab0000430004900051
Completed58646466621451411407113813113769
Not completed159958381061317137
Withdrew: Lost to follow-up0110001101110
Withdrew: Withdrawal by subject14784636961114127
Withdrew: Other1101200001200
Withdrew: Randomized but not treated0000001000000

Outcome measures

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

The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity. Baseline was defined as the last observation prior to or at the date of the first study intervention.

Time frame:
Baseline and Week 12
Reported as:
Mean · Units on a scale
GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Units on a scaleGALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w
GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12-143.7 ± 96.58-139.2 ± 100.71-159.8 ± 110.52-34.4 ± 104.85
Statistical analysis
  • GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w vs GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w · Mixed Model for Repeated Measure · p = <0.001 · Least square (ls) mean difference: 124.2 · 95% CI 89.8 to 158.7LS 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.
  • GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w vs GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w · Mixed Model for Repeated Measure · p = <0.001 · Ls mean difference: 102.7 · 95% CI 68.5 to 136.9LS 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.
  • GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w vs GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w · Mixed Model for Repeated Measure · p = <0.001 · Ls mean difference: 108.7 · 95% CI 73.9 to 143.5LS 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.
PrimaryGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

Clinical response was defined as a decrease from baseline (BL) in CDAI score greater than or equal to (\>=) 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Time frame:
Weeks 48
Reported as:
Number · Percentage of participants
Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48
Percentage of participantsGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 4854.849.011.8
Statistical analysis
  • GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w vs GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 38.1 · 95% CI 27.3 to 48.9Treatment 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.
  • GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w vs GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 42.8 · 95% CI 31.6 to 53.9Treatment 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.
PrimaryGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

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

Time frame:
Weeks 48
Reported as:
Number · Percentage of participants
Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48
Percentage of participantsGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 4838.439.25.3
Statistical analysis
  • GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w vs GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 33.7 · 95% CI 24.1 to 43.2Treatment 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.
  • GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w vs GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 32.9 · 95% CI 23.5 to 42.4Treatment 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.
PrimaryGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

Clinical response was defined as a decrease from baseline in CDAI score \>= 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Time frame:
Weeks 48
Reported as:
Number · Percentage of participants
Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48
Percentage of participantsGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 4848.046.912.5
Statistical analysis
  • GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w vs GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 34.2 · 95% CI 23.2 to 45.3Treatment 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.
  • GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w vs GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 35 · 95% CI 23.5 to 46.5Treatment 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.
PrimaryGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

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

Time frame:
Weeks 48
Reported as:
Number · Percentage of participants
Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48
Percentage of participantsGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 4836.033.65.6
Statistical analysis
  • GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w vs GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 27.9 · 95% CI 18.7 to 37.1Treatment 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.
  • GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w vs GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 30.8 · 95% CI 21.3 to 40.3Treatment 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.
PrimaryRegional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12

Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Time frame:
Week 12
Reported as:
Number · Percentage of participants
Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12
Percentage of participantsGALAXI 2 Placebo (From Group 4)GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2)
Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 1222.447.1
Statistical analysis
  • GALAXI 2 Placebo (From Group 4) vs GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2) · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 25.1 · 95% CI 14.1 to 36.2Treatment 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.
PrimaryRegional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12

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

Time frame:
Week 12
Reported as:
Number · Percentage of participants
Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12
Percentage of participantsGALAXI 2 Placebo (From Group 4)GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2)
Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 1210.537.7
Statistical analysis
  • GALAXI 2 Placebo (From Group 4) vs GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2) · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 27.7 · 95% CI 19.3 to 36.1Treatment 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.
PrimaryRegional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12

Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Time frame:
Week 12
Reported as:
Number · Percentage of participants
Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12
Percentage of participantsGALAXI 3 Placebo (From Group 4)GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2)
Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 1215.347.1
Statistical analysis
  • GALAXI 3 Placebo (From Group 4) vs GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2) · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 31.2 · 95% CI 21.1 to 41.3Treatment 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.
PrimaryRegional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12

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

Time frame:
Week 12
Reported as:
Number · Percentage of participants
Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12
Percentage of participantsGALAXI 3 Placebo (From Group 4)GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2)
Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 1213.936.2
Statistical analysis
  • GALAXI 3 Placebo (From Group 4) vs GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2) · Mantel Haenszel · p = <0.001 · Adjusted treatment difference: 22.1 · 95% CI 12.2 to 31.9Treatment 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.
SecondaryGALAXI 1: Percentage of Participants With Clinical Remission at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryGALAXI 1: Percentage of Participants With Clinical Response at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryGALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryGALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryGALAXI 1: Percentage of Participants With Endoscopic Response at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4
Time frame:
At Week 4

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

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

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Endoscopic Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryGlobal: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12
Time frame:
At Week 12

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission at Week 48 and Endoscopic Response at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryRegional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Remission at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

Adverse events

Collected over From Week 0 up to Week 48. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w0/73 (0%)5/73 (6.8%)33/73 (45.2%)
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w0/73 (0%)5/73 (6.8%)34/73 (46.6%)
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w0/73 (0%)6/73 (8.2%)34/73 (46.6%)
GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w0/71 (0%)9/71 (12.7%)44/71 (62%)
GALAXI 1 (Group 5) Placebo q4w0/70 (0%)6/70 (8.6%)27/70 (38.6%)
GALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w0/43 (0%)0/43 (0%)16/43 (37.2%)
GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w0/148 (0%)6/148 (4.1%)80/148 (54.1%)
GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w0/149 (0%)19/148 (12.8%)66/148 (44.6%)
GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w0/150 (0%)18/150 (12%)78/150 (52%)
GALAXI 2 (Group 4) Placebo q4w0/77 (0%)6/77 (7.8%)21/77 (27.3%)
GALAXI 2 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w0/49 (0%)3/49 (6.1%)15/49 (30.6%)
GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w0/151 (0%)15/151 (9.9%)80/151 (53%)
GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w0/148 (0%)13/148 (8.8%)69/148 (46.6%)
GALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w0/150 (0%)17/150 (11.3%)73/150 (48.7%)
GALAXI 3 (Group 4) Placebo q4w0/76 (0%)10/76 (13.2%)30/76 (39.5%)
GALAXI 3 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w0/51 (0%)6/51 (11.8%)19/51 (37.3%)
Most frequent serious events
Showing 10 of 98
Most frequent serious events
EventGALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4wGALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4wGALAXI 2 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4wGALAXI 3 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Crohn's DiseaseGastrointestinal disorders0/730/730/733/711/700/430/1485/1483/1503/771/493/1514/1481/1506/762/51
Anal AbscessInfections and infestations0/730/732/730/710/700/430/1481/1480/1500/770/490/1510/1481/1500/760/51
Anal FistulaGastrointestinal disorders0/730/730/730/710/700/430/1481/1480/1500/770/491/1510/1480/1502/760/51
BronchitisInfections and infestations0/730/730/730/710/700/430/1480/1480/1500/771/490/1510/1480/1500/760/51
Covid-19Infections and infestations0/730/730/730/710/700/430/1480/1480/1500/771/490/1510/1480/1500/760/51
Abdominal PainGastrointestinal disorders0/730/730/730/710/700/430/1481/1480/1501/770/490/1510/1483/1501/760/51
Small Intestinal ObstructionGastrointestinal disorders0/730/731/731/710/700/430/1480/1480/1500/770/493/1511/1481/1500/760/51
Intestinal ObstructionGastrointestinal disorders0/730/730/730/710/700/431/1481/1480/1500/770/492/1511/1482/1501/761/51
Abdominal AbscessInfections and infestations0/730/730/730/710/700/430/1480/1482/1500/770/490/1510/1480/1500/761/51
Abscess LimbInfections and infestations0/730/730/730/710/700/430/1480/1480/1500/770/490/1510/1480/1500/761/51
Most frequent other events
Showing 10 of 14
Most frequent other events
EventGALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4wGALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4wGALAXI 2 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4wGALAXI 3 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w
Covid-19Infections and infestations0/730/730/730/710/700/4322/14818/14824/1502/777/4931/15127/14816/1508/765/51
Crohn's DiseaseGastrointestinal disorders4/735/736/7311/714/705/4312/1488/14812/1508/772/4911/15110/14811/1508/764/51
HeadacheNervous system disorders7/7310/735/736/711/704/4316/1486/14813/1503/771/498/1519/1486/1504/760/51
NasopharyngitisInfections and infestations8/739/738/738/713/704/4310/1487/14812/1502/771/4911/1515/1487/1503/762/51
ArthralgiaMusculoskeletal and connective tissue disorders4/734/738/735/714/703/4314/14814/14812/1504/773/4911/1519/1488/1501/762/51
Upper Respiratory Tract InfectionInfections and infestations4/736/732/737/716/702/4312/14815/14810/1503/772/4913/15114/14813/1503/765/51
AnaemiaBlood and lymphatic system disorders3/736/731/737/714/701/4310/1488/14811/1503/771/495/1517/1485/1505/763/51
PyrexiaGeneral disorders4/733/736/735/712/701/438/14810/14814/1505/771/498/1519/14812/1503/763/51
Abdominal PainGastrointestinal disorders2/732/731/735/713/700/439/14811/14813/1503/771/495/1518/14812/1504/760/51
NauseaGastrointestinal disorders2/732/733/734/712/700/435/1485/1486/1501/770/494/1514/1484/1506/760/51

Baseline characteristics

Baseline characteristics data were presented for all randomized participants who received at least 1 dose of study intervention.

Age, Categorical
Age, Categorical(Participants)GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wTotal
<=18 years00000000000000
Between 18 and 65 years686669696814214414376143146143751352
>=65 years574226471827156
Age, Continuous
Age, Continuous(Years)GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wTotal
Mean40.2 ± 14.2839.3 ± 15.5141.5 ± 14.4136.3 ± 12.0839 ± 12.7936.2 ± 13.0337.3 ± 12.8637 ± 12.7634.1 ± 11.8137.6 ± 13.434.8 ± 11.4837.9 ± 13.6135.8 ± 12.4837.2 ± 13.14
Sex: Female, Male
Sex: Female, Male(Participants)GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wTotal
Female35292726265976623559606626586
Male38444645448972884292888450822
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wTotal
Hispanic or Latino3540485725711465
Not Hispanic or Latino696466696413613913771142136131711295
Unknown or Not Reported143224464458148
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wTotal
American Indian or Alaska Native00200000000002
Asian6109852834321728382319257
Native Hawaiian or Other Pacific Islander301100002011211
Black or African American220131330104323
White615958615811710811156118107116501080
More than one race00000000000000
Unknown or Not Reported123042342426235
Region of Enrollment
Region of Enrollment(Participants)GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4wGALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8wGALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wGALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4wGALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8wGALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8wGALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8wTotal
Australia100005261213122
Austria10100100000003
Belarus210320000011010
Belgium00001010011105
Bosnia and Herzegovina110102131022014
Brazil0000067928612353
Canada002001641245227
China000001819101215221212120
Colombia00000000001001
Croatia01000000020104
Czech Republic111102003141116
France226124242112130
Georgia131110011001010
Germany340222420421127
Greece00001000000001
Hungary000001450414120
India000000121222010
Israel222204102090226
Italy222011011310115
Japan3564247131964468
Jordan110214344939142
Latvia311001110110010
Lebanon000101411234219
Lithuania00210000000003
Malaysia120103121021115
Netherlands000000104412012
New Zealand100004031210012
Poland11181521253324331026322816292
Portugal00000111000104
Macedonia10000111111119
Russian Federation638431414141013998115
Saudi Arabia00000010001002
Slovakia110221310321017
Korea, South121322542233232
Spain111011021103012
Serbia233628973528664
Taiwan11101100001107
Tunisia000003511521119
Turkey110211200011010
Ukraine97776111278111074106
United Kingdom00000000020305
United States1410136147682109155119
08

Study locations

579 sites

Showing the first 100 of 579 sites across 43 countries. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Afzali A, Danese S, Panaccione R, Rubin DT, Sands BE, Reinisch W, Panes J, Van Rampelbergh R, Terry NA, Salese L, Vetter ML, Yee J, Corbett C, van Duijnhoven W, Hisamatsu T, Andrews JM, D'Haens GR; GALAXI 1 investigators. Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial. Inflamm Bowel Dis. 2026 May 1:izag055. doi: 10.1093/ibd/izag055. Online ahead of print. PubMed 42065683 ↗
  • 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. PubMed 40684778 ↗
  • 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. PubMed 40357993 ↗
  • 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. PubMed 38104569 ↗
  • 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. PubMed 35134323 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

2 registry updates since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • GUZ Novgorod Regional Clinical Hospital · Velikiy Novgorod, Russia
Show 1 removed
  • GUZ Novgorod Regional Clinical Hospital · Veliky Novgorod, Russia
Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    1 site added, 1 site removed
    Show site
    • GUZ Novgorod Regional Clinical Hospital · Velikiy Novgorod, Russia
    Show 1 removed
    • GUZ Novgorod Regional Clinical Hospital · Veliky Novgorod, Russia
    + 1 other change: verification date
  2. Sep 28, 2026
    Minor edits only
    + 2 other changes: verification date and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03466411
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Mar 15, 2018
Start date
Apr 13, 2018
Primary completion
Oct 20, 2023
Completion
Jan 28, 2028 (estimated)
Results posted
May 7, 2025
Last update
Nov 3, 2026

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Guselkumab · Ustekinumab

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