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 systemic side effects like adrenal suppression, increased infection risk, and osteoporosis, especially with long-term use. Biologics, including IL-23 inhibitors, may lead to increased risk of 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?

Prior FDA approvals for the treatment of Ulcerative Colitis include several biologic agents targeting different inflammatory pathways. Ustekinumab, an IL-12/23 inhibitor, is similar to Guselkumab and has been approved for UC. Anti-TNF agents like infliximab and adalimumab have also been approved and are widely used for moderate to severe UC. Vedolizumab, an anti-integrin agent, is another biologic approved for UC, focusing on gut-specific inflammation. These treatments have provided significant advancements in managing UC by targeting specific components of the immune response.

What other types of research exist?

Promising alternatives to Guselkumab for Ulcerative Colitis patients include Ustekinumab, an IL-12 and IL-23 antagonist, and Vedolizumab, an integrin receptor antagonist. Both have shown efficacy and safety in treating UC. Additionally, Risankizumab, another IL-23 inhibitor, has shown positive results in clinical trials for Crohn's disease and may be considered for UC treatment.

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Monoclonal Antibodies

Guselkumab for Ulcerative Colitis (QUASAR 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

Moderately to severely active UC, defined by modified Mayo score

Documented diagnosis of ulcerative colitis (UC)

Must not have

Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease

Receiving prohibited medications and/or treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 44

Summary

This trial is testing guselkumab, a medication that targets inflammation, in patients with moderate to severe ulcerative colitis. Guselkumab works by attaching to a protein to reduce inflammation in the colon. This medication has shown promise in treating conditions like ulcerative colitis.

Who is the study for?

This trial is for people with moderate to severe ulcerative colitis who haven't responded well to other treatments. Participants must have a confirmed diagnosis of UC and meet specific lab test requirements. Those with only rectal UC, less than 20 cm of colon affected, fistulas, or certain other bowel diseases can't join.

What is being tested?

The study is testing the effectiveness and safety of guselkumab compared to a placebo in treating ulcerative colitis. Guselkumab is given to see if it can help reduce symptoms and improve the condition of those with active UC.

What are the potential side effects?

Potential side effects from guselkumab may include allergic reactions at the injection site, headaches, fatigue, skin rashes, and possible increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ulcerative colitis is moderate to severe, based on a specific score.

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I have been diagnosed with ulcerative colitis.

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 a specific type of colitis or Crohn's disease.

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I am not taking any medications or treatments that are not allowed.

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My ulcerative colitis affects only my rectum or less than 20 cm of my colon.

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I have or had a fistula.

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I have a stoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 44

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 44

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 44 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Induction Study 1: Clinical Response at Week 12

Induction Study 2: Clinical Remission at Week 12

Maintenance Study: Clinical Remission at Week 44

Secondary study objectives

Induction Study 1: Clinical Remission at Week 12

Induction Study 1: Endoscopic Healing at Week 12

Induction Study 1: Endoscopic Normalization at Week 12

+20 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

Placebo Group

Group I: Maintenance Study: Maintenance Dose Regimen 2Experimental Treatment1 Intervention

Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).

Group II: Maintenance Study: Maintenance Dose Regimen 1Experimental Treatment1 Intervention

Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).

Group III: Induction Study 2: Guselkumab IVExperimental Treatment1 Intervention

Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Group IV: Induction Study 1: Guselkumab Dose 2Experimental Treatment1 Intervention

Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Group V: Induction Study 1: Guselkumab Dose 1Experimental Treatment1 Intervention

Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Group VI: Induction Study 2: Placebo IVPlacebo Group1 Intervention

Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Group VII: Induction Study 1: Placebo IVPlacebo Group1 Intervention

Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Group VIII: Maintenance Study: Placebo SCPlacebo Group1 Intervention

Participants will receive matching placebo SC q4w.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

0 / 7Eligibility 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 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 treatments help reduce inflammation and prevent immune system overactivity, which is essential for managing UC symptoms and preventing flare-ups. 5-aminosalicylates, like mesalamine, reduce inflammation directly in the colon lining, while glucocorticoids, such as prednisone, suppress the overall immune response. Understanding these mechanisms is vital for UC patients as it helps tailor treatment plans to effectively manage their condition and improve their quality of life.

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