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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 44
Awards & highlights

QUASAR Trial Summary

This trial will test if guselkumab is an effective and safe treatment for people with moderate to severe 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.Check my eligibility
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.See study design
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.

QUASAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ulcerative colitis is moderate to severe, based on a specific score.
Select...
I have been diagnosed with ulcerative colitis.

QUASAR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Induction Study 1: Clinical Response at Week 12
Induction Study 2: Clinical Remission at Week 12
Maintenance Study: Clinical Remission at Week 44
Secondary outcome measures
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
9%
Injection site reaction
8%
Upper respiratory tract infection
7%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab
Guselkumab
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up

QUASAR 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
~5990

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,244 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
562 Patients Enrolled for Ulcerative Colitis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,958,841 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
562 Patients Enrolled for Ulcerative Colitis

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04033445 — Phase 2 & 3
Ulcerative Colitis Research Study Groups: Induction Study 2: Guselkumab IV, Induction Study 2: Placebo IV, Induction Study 1: Guselkumab Dose 1, Induction Study 1: Placebo IV, Induction Study 1: Guselkumab Dose 2, Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Placebo SC, Maintenance Study: Maintenance Dose Regimen 2
Ulcerative Colitis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT04033445 — Phase 2 & 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04033445 — Phase 2 & 3

Frequently Asked Questions

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

Has this type of trial been conducted before?

"Janssen Research & Development, LLC first sponsored a study of Guselkumab in 2018 with 1406 participants. After the initial Phase 2 & 3 approval process was completed, there are now 21 ongoing trials involving Guselkumab being conducted in 282 cities and 57 countries."

Answered by AI

How many people can take part in this clinical research project?

"As of November 3rd, 2022, this clinical trial is no longer actively recruiting patients. This study was first posted on September 26th, 2019. If you are seeking other studies, there are 424 clinical trials actively searching for patients with ulcerative colitis and 21 studies for Guselkumab that are still enrolling participants."

Answered by AI

Are new test subjects needed for this experiment?

"Although this specific trial is not currently looking for patients, the data hosted on clinicaltrials.gov reports that it was last edited on 11/3/2022. At present, there are 445 other medical trials actively recruiting patients."

Answered by AI

Are there different hospitals conducting this research in Canada?

"Velocity Clinical Research Spokane in Spokane, Washington, Columbus Clinical Services LLC in Miami, Florida, and Om Research LLC in Lancaster, California are all sites participating in this study. Additionally, there are 39 other research centres across the country also taking part."

Answered by AI

What are the key goals that researchers hope to achieve with this clinical trial?

"Janssen Research & Development, LLC, the primary sponsor of this trial, defines the primary outcome as 'Maintenance Study: Clinical Remission at Week 44'. Additionally, this study will evaluate secondary outcomes including but not limited to 'Induction Study 2: Symptomatic Remission at Week 2', 'Induction Study 1: Clinical remission per modified Mayo score.' and 'Maintenance Study: Clinical Response at Week 44' ."

Answered by AI

What other medical research studies have used Guselkumab?

"The medication known as Guselkumab was first studied in 2018 at Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro. So far, 18303 studies have been completed with 21 more currently active clinical trials. The majority of these ongoing tests are taking place in Spokane, Washington."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
2019. "A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04033445.
All > Inflammatory Bowel Disease > Colitis
~193 spots leftby Apr 2025
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