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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 moderate to severe CD as assessed by CDAI, stool frequency (SF), abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
Must not have
Current diagnosis of ulcerative colitis or indeterminate colitis
Unstable doses of concomitant Crohn's disease therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Summary
This trial is testing guselkumab, a medication that reduces inflammation, in patients with Crohn's disease. It aims to find the best dose and check its safety and effectiveness. The medication works by calming the immune system to reduce symptoms.
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.
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).
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe Crohn's disease based on specific health scores.
Select...
I am a woman who can have children and have tested negative for pregnancy.
Select...
I have had Crohn's disease for at least 3 months with inflammation in my colon, ileum, or both.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with ulcerative colitis or indeterminate colitis.
Select...
My Crohn's disease medication dose has been changing.
Select...
I have complications from Crohn's disease like blockages or short gut syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreSide effects data
From 2020 Phase 4 trial • 1027 Patients • NCT035733231%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Guselkumab Post-Treatment Follow Up
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 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.
Group VIII: 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab Dose 2
2018
Completed Phase 2
~300
Guselkumab Dose 3
2018
Completed Phase 1
~30
Guselkumab Dose 1
2018
Completed Phase 2
~300
Guselkumab
2015
Completed Phase 4
~6080
Ustekinumab
2015
Completed Phase 4
~4080
Placebo
1995
Completed Phase 3
~2670
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Crohn's Disease work by targeting specific inflammatory pathways to reduce inflammation and manage symptoms. Guselkumab, an IL-23 inhibitor, works by blocking the interleukin-23 protein, which plays a key role in the inflammatory process.
This helps to reduce the immune response that causes inflammation in the gut. Similarly, anti-TNF agents like infliximab and adalimumab inhibit tumor necrosis factor-alpha (TNF-α), another protein involved in systemic inflammation.
IL-12/23 inhibitors like ustekinumab target both interleukin-12 and interleukin-23, further reducing inflammation. These treatments are crucial for Crohn's Disease patients as they help to control the chronic inflammation that leads to symptoms and complications, improving quality of life and reducing the need for surgical interventions.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,400,961 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,978,988 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with ulcerative colitis or indeterminate colitis.I have Crohn's disease and haven't responded well to standard or biologic treatments.I have moderate to severe Crohn's disease based on specific health scores.I am a woman who can have children and have tested negative for pregnancy.I haven't taken any Crohn's disease biologics or experimental treatments recently.I have had Crohn's disease for at least 3 months with inflammation in my colon, ileum, or both.My Crohn's disease medication dose has been changing.I have complications from Crohn's disease like blockages or short gut syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)
- Group 2: Phase 2 (GALAXI 1): Group 4 (Ustekinumab)
- Group 3: Phase 2 (GALAXI 1): Group 3 (Guselkumab)
- Group 4: Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)
- Group 5: Phase 2 (GALAXI 1): Group 2 (Guselkumab)
- Group 6: Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
- Group 7: Phase 2 (GALAXI 1): Group 1 (Guselkumab)
- Group 8: Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Crohn's Disease Patient Testimony for trial: Trial Name: NCT03466411 — Phase 2 & 3