Guselkumab for Ulcerative Colitis
(QUASAR Trial)

Recruiting in Palo Alto (17 mi)

+498 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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.

Inclusion Criteria

Screening laboratory test results within the parameters specified in the protocol

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

I have been diagnosed with ulcerative colitis.

See 1 more

Exclusion Criteria

I have been diagnosed with a specific type of colitis or Crohn's disease.

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

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

See 2 more

Treatment Details

Interventions

Guselkumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.