VTX002 for Ulcerative Colitis

Recruiting at 103 trial locations

Overseen By Chohee Yun, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oppilan Pharma Ltd

Disqualifiers: Severe colitis, Crohn's, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

213 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if taking VTX002 regularly as a tablet is safe and effective for people with moderate to severe ulcerative colitis. The goal is to see if it can reduce symptoms and heal the gut lining.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Snehal Naik, PhD

Principal Investigator

Ventyx Biosciences, Inc

Eligibility Criteria

This trial is for people who've had moderate to severe ulcerative colitis (UC) for at least 3 months. They must have active UC confirmed by a special camera test called endoscopy. People with other types of colitis, severe widespread colitis, Crohn's disease, or a history of certain abnormal connections in their intestines can't join.

Inclusion Criteria

Active UC confirmed by endoscopy

I was diagnosed with ulcerative colitis more than 3 months ago.

Exclusion Criteria

I have severe widespread inflammation in my colon.

I have been diagnosed with a specific type of colitis.

I have been diagnosed with Crohn's disease or have a history of fistulas related to it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Induction Treatment

Participants receive VTX002 Dose A, Dose B, or placebo for 13 weeks, including 7 days of titration followed by 12 weeks of treatment at the assigned dose

13 weeks

Visits at Weeks 1, 4, 8, and 13

Long-Term Extension (LTE) Treatment

Participants continue treatment with VTX002 for up to 39 weeks

39 weeks

Open-Label Extension (OLE) Treatment

Participants may opt into continuation of treatment with VTX002 for up to 143 weeks

143 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• VTX002

Trial Overview The study tests if VTX002 tablets are safe and effective when taken daily by UC patients compared to a placebo (a pill without any medicine). Participants will be randomly assigned to receive either VTX002 at two different doses or placebo and followed up for up to 36 months including various treatment phases.

Participant Groups

Group I: VTX002 Dose B Experimental Treatment 1 Intervention

VTX002 Dose B tablet administered orally once daily

Group II: VTX002 Dose A Experimental Treatment 1 Intervention

VTX002 Dose A tablet administered orally once daily

Group III: Placebo Placebo Group 1 Intervention

Placebo tablet administered orally once daily

Who Is Running the Clinical Trial?

Oppilan Pharma Ltd

Lead Sponsor

Trials

2

Recruited

230+