Guselkumab for Ulcerative Colitis
(ASTRO Trial)

Recruiting in Palo Alto (17 mi)

+342 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Signed informed consent form

I am 18 years old or older.

My ulcerative colitis is moderate to severe according to the Mayo score.

See 2 more

Exclusion Criteria

I currently have a severe case of COVID-19.

My ulcerative colitis affects only my rectum.

I haven't had surgery in the last 8 weeks and don't plan to during the study.

See 2 more

Treatment Details

Interventions

Guselkumab (Monoclonal Antibodies)

Trial OverviewThe 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).

Participant Groups

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.

Guselkumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tremfya for: