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Monoclonal Antibodies

Guselkumab for Crohn's Disease (GALAXI Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

GALAXI Trial Summary

This trial will test the effects of a new drug, guselkumab, on Crohn's disease. The study will measure the drug's clinical efficacy, safety, and endoscopic efficacy.

Who is the study for?
This trial is for individuals with moderate to severe Crohn's Disease, confirmed by specific tests and criteria. Participants should have had an inadequate response or intolerance to conventional or biologic therapies. They must not have ulcerative colitis, indeterminate colitis, or complications like symptomatic strictures. Women of childbearing potential need a negative pregnancy test.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of different doses of Guselkumab in treating Crohn's Disease compared to Ustekinumab and a placebo. It aims to assess both clinical outcomes (symptom relief) and endoscopic results (internal healing as seen through a scope).See study design
What are the potential side effects?
While the side effects are not specified here, Guselkumab may typically cause immune system reactions, injection site reactions, infections, headaches, and possibly digestive issues based on its mechanism of action.

GALAXI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Crohn's disease for at least 3 months.
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I have moderate to severe Crohn's disease based on my symptoms and test scores.
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I am a woman who can have children and have tested negative for pregnancy.
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I have Crohn's disease and haven't responded well to standard or biologic treatments.
Select...
I have had Crohn's disease for at least 3 months, affecting my colon, ileum, or both.
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I have moderate to severe Crohn's disease based on my symptoms and test scores.
Select...
I am a woman who can have children and have tested negative for pregnancy.
Select...
I have Crohn's disease and standard treatments haven't worked for me.

GALAXI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Phase 3: Clinical Response at Week 12 and Clinical Remission at Week 48
Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48
Secondary outcome measures
Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12
Phase 2: Clinical Remission at Week 12
Phase 2: Clinical Response at Week 12
+15 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Upper respiratory tract infection
1%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up
Ixekizumab
Guselkumab

GALAXI Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)Experimental Treatment2 Interventions
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.
Group II: Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)Experimental Treatment1 Intervention
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.
Group III: Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)Experimental Treatment2 Interventions
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.
Group IV: Phase 2 (GALAXI 1): Group 3 (Guselkumab)Experimental Treatment2 Interventions
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.
Group V: Phase 2 (GALAXI 1): Group 2 (Guselkumab)Experimental Treatment2 Interventions
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.
Group VI: Phase 2 (GALAXI 1): Group 1 (Guselkumab)Experimental Treatment2 Interventions
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.
Group VII: Phase 2 (GALAXI 1): Group 4 (Ustekinumab)Active Control1 Intervention
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.
Group VIII: Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab Dose 2
2018
Completed Phase 2
~280
Guselkumab Dose 3
2018
Completed Phase 1
~30
Guselkumab Dose 1
2018
Completed Phase 2
~280
Guselkumab
2015
Completed Phase 4
~5970
Ustekinumab
2013
Completed Phase 4
~4140
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
971 Previous Clinical Trials
6,382,175 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
743 Previous Clinical Trials
3,958,288 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03466411 — Phase 2 & 3
Crohn's Disease Research Study Groups: Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab), Phase 2 (GALAXI 1): Group 4 (Ustekinumab), Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab), Phase 2 (GALAXI 1): Group 3 (Guselkumab), Phase 2 (GALAXI 1): Group 1 (Guselkumab), Phase 2 (GALAXI 1): Group 2 (Guselkumab), Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab), Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)
Crohn's Disease Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT03466411 — Phase 2 & 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03466411 — Phase 2 & 3
Crohn's Disease Patient Testimony for trial: Trial Name: NCT03466411 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the desired outcome of this research?

"The primary outcome of this trial will be monitored from Baseline to Week 48 and Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48. However, other objectives include Phase 3: Clinical Response at Week 4 (defined as Clinical response based on CDAI score.), Phase 3: Clinical Remission at Week 48 (defined as remission based on CDAI score.), or Phase 3: Endoscopic Remission at week 48 (defined as endoscopic remission based on SES-CD score.)."

Answered by AI

How is Guselkumab most often employed?

"Guselkumab is the standard medication used to treat adrenal cortex hormone conditions. Additionally, Guselkumab has been shown to be effective in treating other issues like psoriasis, Crohn's disease, and patients who have not responded well to other TNF therapies."

Answered by AI

Could you tell us what other drugs have been studied in relation to Guselkumab?

"There are currently 55 clinical trials underway that focus on Guselkumab. Of these active studies, 24 have reached Phase 3 testing. Though the majority of research is based in Gdansk, Pomorskie, there are 4606 total locations running tests for this potential treatment."

Answered by AI

Are there still vacancies in this study for people who want to participate?

"This clinical trial is not presently recruiting candidates at this time. The trial was first posted on 4/13/2018 and was most recently updated on 11/9/2022. If you are exploring for other studies, there are presently 258 studies actively recruiting participants with ileocolitis and 55 trials for Guselkumab actively searching for participants."

Answered by AI

How many different hospitals are participating in this trial?

"There are 100 running for this trial including Gastroenterology Associates in Baton Rouge, Gastroenterology and Internal Medicine Research Institute (GIRI) in Edmonton, and Pharmaceutical Integrated Research Company in Waterloo, along with other locations."

Answered by AI

What is the projected sample size for this research project?

"This particular trial is not enrolling patients at this moment in time. The first posting was on April 13th, 2018 and the last edit was on November 9th, 2022. However, there are currently 258 trials actively recruiting patients with ileocolitis and 55 Guselkumab trials that have open enrolment."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Diet change. Increase in fiber. *****.
PatientReceived no prior treatments
~206 spots leftby Feb 2025