What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, including biologics like Guselkumab (IL-23 inhibitor), anti-TNF agents (e.g., infliximab, adalimumab), and immunomodulators (e.g., azathioprine), have various side effects. Guselkumab and other biologics can cause infections, injection site reactions, and potential allergic reactions. Anti-TNF agents may lead to increased risk of infections, infusion reactions, and potential development of antibodies against the drug. Immunomodulators can cause bone marrow suppression, liver toxicity, and increased risk of infections. Glucocorticoids, often used for induction therapy, are associated with significant side effects such as weight gain, osteoporosis, hypertension, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of Crohn's Disease, primarily focusing on anti-TNF agents such as infliximab, adalimumab, and certolizumab pegol. These drugs target tumor necrosis factor-alpha (TNF-alpha) to reduce inflammation. Additionally, ustekinumab, which targets IL-12 and IL-23, has been approved for patients with moderate to severe Crohn's Disease. These treatments aim to modulate the immune response and reduce inflammation, similar to the mechanism of guselkumab, which specifically inhibits IL-23.

What other types of research exist?

Promising novel alternatives to Guselkumab for Crohn's Disease patients include: 1) Ustekinumab, which targets IL-12 and IL-23 and has shown efficacy in Crohn's Disease. 2) Adalimumab and Infliximab, which are TNF inhibitors and have been effective in preventing postoperative recurrence and maintaining remission. 3) Vedolizumab, which targets integrin α4β7 and is effective in managing inflammatory bowel disease. 4) Tofacitinib and Upadacitinib, which are JAK inhibitors and offer another mechanism of action for reducing inflammation.

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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 below

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I have moderate to severe Crohn's disease based on specific health 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 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:

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I have been diagnosed with ulcerative colitis or indeterminate colitis.

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My Crohn's disease medication dose has been changing.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

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 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

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

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

0 / 6Eligibility criteria met

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.