Trial · NCT03466411
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
NCT03466411, Phase 2, Phase 3, Active not recruiting, Janssen Research & Development, LLC; results first posted 2025-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease. Trials, record NCT03466411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03466411
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
- NCT number
- NCT03466411
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,409 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Crohn's Disease
- Interventions
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Guselkumab Dose 4, Guselkumab Dose 5, Guselkumab, Ustekinumab, Placebo
- First posted
- 2018-03-15
- Last updated
- 2026-11-03
- Other registries' IDs
- eudract:2017-002195-13
- Results first posted
- 2025-05-07
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 | Baseline and 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. |
| Primary | Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 | Weeks 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. |
| Primary | Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 | Weeks 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. |
| Primary | Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 | Weeks 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. |
| Primary | Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 | Weeks 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. |
| Primary | Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12 | 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 | Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12 | 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 | Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12 | 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 | Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12 | 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. |
| Secondary | GALAXI 1: Percentage of Participants With Clinical Remission at Week 12 | At Week 12 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 | Baseline and Week 12 | 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. | Units on a scale | MEAN |
| PRIMARY | Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 | Weeks 48 | 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. | Percentage of participants | NUMBER |
| PRIMARY | Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 | Weeks 48 | 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. | Percentage of participants | NUMBER |
| PRIMARY | Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 | Weeks 48 | 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. | Percentage of participants | NUMBER |
| PRIMARY | Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 | Weeks 48 | 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. | Percentage of participants | NUMBER |
| PRIMARY | Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12 | Week 12 | 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. | Percentage of participants | NUMBER |
| PRIMARY | Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12 | Week 12 | 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. | Percentage of participants | NUMBER |
| PRIMARY | Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12 | Week 12 | 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. | Percentage of participants | NUMBER |
| PRIMARY | Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12 | Week 12 | 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. | Percentage of participants | NUMBER |
| SECONDARY | GALAXI 1: Percentage of Participants With Clinical Remission at Week 12 | At Week 12 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 | GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w | -143.7 | Standard Deviation 96.58 | Units on a scale | |
| GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 | GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w | -139.2 | Standard Deviation 100.71 | Units on a scale | |
| GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 | GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | -159.8 | Standard Deviation 110.52 | Units on a scale | |
| GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 | GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w | -34.4 | Standard Deviation 104.85 | Units on a scale | |
| Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 | GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 54.8 | Percentage of participants | ||
| Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 | GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 49.0 | Percentage of participants | ||
| Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48 | GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w | 11.8 | Percentage of participants | ||
| Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 | GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 38.4 | Percentage of participants | ||
| Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 | GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 39.2 | Percentage of participants | ||
| Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48 | GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w | 5.3 | Percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow52
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w | 73 | |
| Overall Study | STARTED | GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w | 73 | |
| Overall Study | STARTED | GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 73 | |
| Overall Study | STARTED | GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w | 71 | |
| Overall Study | STARTED | GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8w | 70 | |
| Overall Study | STARTED | GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 148 | |
| Overall Study | STARTED | GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 149 | |
| Overall Study | STARTED | GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w | 150 | |
| Overall Study | STARTED | GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w | 77 | |
| Overall Study | STARTED | GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 151 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 participant flowAdverse events1,792
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w | 3 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w | 6 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 1 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w | 7 | 71 | |
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 1 (Group 5) Placebo q4w | 4 | 70 | |
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w | 1 | 43 | |
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 10 | 148 | |
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 8 | 148 | |
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w | 11 | 150 | |
| other | Anaemia | Blood and lymphatic system disorders | GALAXI 2 (Group 4) Placebo q4w | 3 | 77 |
1 to 10 of 1,792Source ClinicalTrials.gov
See all 1,792 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w | 0 | 73 |
| Total, all-cause mortality | GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w | 0 | 73 |
| Total, all-cause mortality | GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 0 | 73 |
| Total, all-cause mortality | GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w | 0 | 71 |
| Total, all-cause mortality | GALAXI 1 (Group 5) Placebo q4w | 0 | 70 |
| Total, all-cause mortality | GALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w | 0 | 43 |
| Total, all-cause mortality | GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w | 0 | 148 |
| Total, all-cause mortality | GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w | 0 | 149 |
| Total, all-cause mortality | GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w | 0 | 150 |
| Total, all-cause mortality | GALAXI 2 (Group 4) Placebo q4w | 0 | 77 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT03466411/registered?page=2