What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include 5-aminosalicylic acid (5-ASA) agents, glucocorticoids, and biologics like IL-23 inhibitors (e.g., Guselkumab). 5-ASA agents can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids are associated with long-term side effects like adrenal suppression, osteoporosis, and increased infection risk. Biologics, including IL-23 inhibitors, may lead to infections, injection site reactions, and potential allergic reactions. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Ulcerative Colitis, particularly those targeting cytokines involved in inflammation. Infliximab and adalimumab, both TNF-alpha inhibitors, have been widely used and shown efficacy in inducing and maintaining remission. Ustekinumab, an IL-12/23 inhibitor, has also been approved for moderate to severe cases, offering a mechanism of action similar to Guselkumab's IL-23 inhibition. Vedolizumab, an integrin receptor antagonist, is another biologic option that targets gut-specific inflammation. These treatments highlight the evolving landscape of biologic therapies aimed at modulating the immune response in Ulcerative Colitis.

What other types of research exist?

Promising alternatives to Guselkumab for UC treatment include Ustekinumab (IL-12/23 inhibition), Vedolizumab (integrin inhibition), and Risankizumab (IL-23 inhibition). These agents have demonstrated efficacy in clinical trials and are viable options for patients seeking novel treatments in 2024.

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Monoclonal Antibodies

Guselkumab for Ulcerative Colitis (ASTRO Trial)

Phase 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 12 and 24

Awards & highlights

Pivotal Trial

Summary

This trial tests an injectable medication called guselkumab on people with severe ulcerative colitis. It aims to see if blocking a protein that causes inflammation can help these patients achieve remission.

Who is the study for?

This trial is for adults with moderately to severely active ulcerative colitis who haven't responded well to or can't tolerate standard treatments. They must have been diagnosed at least 12 weeks before the study starts and cannot be on certain medications, have recent or upcoming surgery that could affect results, just rectal UC, other types of colitis, Crohn's disease, or an active COVID-19 infection.

What is being tested?

The trial is testing three different doses of a medication called Guselkumab against a placebo in people with ulcerative colitis. The main goal is to see if Guselkumab helps patients achieve clinical remission better than no treatment (placebo).

What are the potential side effects?

Guselkumab may cause side effects such as infections due to immune system suppression, allergic reactions at the injection site, headaches, and possibly increased risk of developing cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 12 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 12 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Clinical Remission

Clinical Response

Endoscopic Improvement

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 2: GuselkumabExperimental Treatment2 Interventions

Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.

Group II: Group 1: GuselkumabExperimental Treatment2 Interventions

Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.

Group III: Group 3: PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo SC injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab Dose 1

2018

Completed Phase 2

~300

Guselkumab Dose 2

2018

Completed Phase 2

~300

Guselkumab Dose 3

2018

Completed Phase 1

~30

Do I qualify?Apply below to find out

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 Ulcerative Colitis (UC) include biologic therapies, 5-aminosalicylates, and glucocorticoids. Biologic therapies, such as Guselkumab, work by inhibiting specific cytokines like interleukin-23 (IL-23), which play a crucial role in the inflammatory process of UC. By targeting IL-23, these therapies help reduce inflammation and promote mucosal healing. 5-aminosalicylates, like mesalamine, act locally in the colon to reduce inflammation and are often used for mild to moderate UC. Glucocorticoids, such as prednisone, are potent anti-inflammatory agents used for short-term flare control but are not suitable for long-term maintenance due to their side effect profile. Understanding these mechanisms is essential for UC patients as it helps tailor treatment plans to effectively manage symptoms and maintain remission.

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