Oral NX-13 for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+45 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AbbVie

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for people with moderate to severe ulcerative colitis. The goal is to see if this treatment can reduce inflammation and improve symptoms. The study includes a period to monitor the effects over time.

Eligibility Criteria

This trial is for adults aged 18-75 with moderate to severe ulcerative colitis diagnosed at least 90 days prior. Participants must have a Mayo Score of ≥5 indicating active disease. Not eligible are those with fulminant colitis, toxic megacolon, Crohn's disease, infections, or conditions likely requiring hospitalization or surgery within 12 weeks.

Inclusion Criteria

I am between 18 and 75 years old.

I was diagnosed with ulcerative colitis over 90 days ago, confirmed by a tissue test.

RBS ≥ 1.

See 2 more

Exclusion Criteria

I have been diagnosed with a specific type of colitis.

My doctor thinks I might need hospital care or surgery for my ulcerative colitis soon.

I have a bacterial or parasitic stomach or intestine infection.

See 2 more

Treatment Details

Interventions

NX-13 250mg (Unknown)
NX-13 750mg (Unknown)
NX-13 Placebo (Unknown)

Trial OverviewThe study tests two doses of NX-13 (250mg and 750mg) against a placebo in people with ulcerative colitis. It's a Phase 2 trial that includes an initial treatment phase followed by long-term extension to assess the drug's effectiveness and safety over time.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: NX-13 750mgExperimental Treatment1 Intervention

Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.

Group II: NX-13 250mgExperimental Treatment1 Intervention

Group III: NX-13 PlaceboPlacebo Group1 Intervention