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Monoclonal Antibodies

Open-label Maintenance Phase: Guselkumab SC for Ulcerative Colitis (QUASAR Jr Trial)

Phase 3

Recruiting

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

Documented diagnosis of ulcerative colitis (UC) with a biopsy report supporting the diagnosis available in the source documents

Moderately to severely active UC defined by specific Mayo scores and endoscopy subscores as determined by central review

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 12 to week 56

Awards & highlights

QUASAR Jr Trial Summary

"This trial aims to see how well guselkumab works in children with moderate to severe ulcerative colitis after they have already responded well to the initial treatment."

Who is the study for?

This trial is for children and teenagers with moderately to severely active ulcerative colitis, a type of inflammatory bowel disease. Participants must have shown some response to earlier treatment phases to qualify.Check my eligibility

What is being tested?

The study tests the effectiveness of Guselkumab, a medication, in young patients with ulcerative colitis. It compares Guselkumab against a placebo (a substance with no therapeutic effect) over time.See study design

What are the potential side effects?

Guselkumab may cause side effects like infections, allergic reactions, headaches, stomach pain, and injection site reactions. The severity can vary from person to person.

QUASAR Jr Trial Eligibility Criteria

Inclusion Criteria

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

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I have a confirmed diagnosis of ulcerative colitis with biopsy proof.

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My ulcerative colitis is moderate to severe, confirmed by specific tests.

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I weigh at least 10 kilograms.

QUASAR Jr Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 12 to week 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 12 to week 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 12 to week 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Clinical Remission at Week 56

Secondary outcome measures

European Union: Percentage of Participants With Endoscopic Healing at Week 56

European Union: Percentage of Participants with Endoscopic Healing at Week 12

Number of Participants with Incidence of Anti-guselkumab Antibodies

+18 more

QUASAR Jr Trial Design

4Treatment groups

Experimental Treatment

Group I: Open-label Maintenance Phase: Guselkumab SCExperimental Treatment1 Intervention

Week 12 non-responders will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.

Group II: Open-label Induction Phase: Guselkumab Subcutaneously (SC)Experimental Treatment1 Intervention

Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.

Group III: Open-label Induction Phase: Guselkumab Intravenously (IV)Experimental Treatment1 Intervention

Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.

Group IV: Double-blind Maintenance Phase: Guselkumab SC or Guselkumab SC and Placebo SCExperimental Treatment2 Interventions

At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive a guselkumab dose SC based on their BW or a guselkumab dose SC based on their BW and placebo SC up to Week 56.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Matching Placebo

2012

Completed Phase 4

~10710

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,572 Total Patients Enrolled

3 Trials studying Ulcerative Colitis

1,626 Patients Enrolled for Ulcerative Colitis

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,960,158 Total Patients Enrolled

3 Trials studying Ulcerative Colitis

1,626 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

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

What criteria must individuals meet to participate in this medical study?

"Patients aged between 2 and 17 years old diagnosed with ulcerative colitis are sought to participate in this study, which aims to recruit a total of 120 individuals."

Answered by AI

Can individuals who are above the age of 55 participate in this research study?

"Eligible candidates for this study must fall within the age bracket of 2 to 17 years. There are a total of 65 trials catering to individuals under 18 and 314 studies targeting those over the age of 65."

Answered by AI

Are there any ongoing efforts to enroll participants in this medical study at the moment?

"As per clinicaltrials.gov, this investigation is actively pursuing candidates. The trial was first made public on January 19th, 2024 and its latest update was on February 7th, 2024."

Answered by AI

What is the overall count of participants involved in this clinical investigation?

"Affirmative. The details on clinicaltrials.gov indicate an ongoing recruitment phase for this study, which was first listed on January 19th, 2024 and last revised on February 7th, 2024. A total of 120 individuals are sought across two designated sites."

Answered by AI

What are the safety considerations for patients receiving guselkumab intravenously during the open-label induction phase?

"According to our team at Power, the safety rating for the Open-label Induction Phase: Guselkumab Intravenously (IV) trial is a 3. This is due to its Phase 3 status, indicating existing efficacy data and numerous rounds of safety data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

2024. "A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06260163.

All > Ulcerative Colitis > Indianapolis