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Unknown

VTX002 for Ulcerative Colitis

Phase 2
Waitlist Available
Research Sponsored by Oppilan Pharma Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of induction treatment period to week 13
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in treating moderate to severe ulcerative colitis. Up to 180 participants will be given the new drug daily for 28 days to 13 weeks, and then followed for up to 36 months.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the specific side effects of VTX002 aren't listed here, common side effects from drugs treating UC may include headache, nausea, fatigue, abdominal pain, and possible reactions at the drug's entry point into the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of induction treatment period to week 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of induction treatment period to week 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical remission at 13 weeks
Secondary outcome measures
Endoscopic improvement at Week 13
Endoscopic improvement-histologic remission at Week 13
Histologic remission at Week 13
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: VTX002 Dose BExperimental Treatment1 Intervention
VTX002 Dose B tablet administered orally once daily
Group II: VTX002 Dose AExperimental Treatment1 Intervention
VTX002 Dose A tablet administered orally once daily
Group III: PlaceboPlacebo Group1 Intervention
Placebo tablet administered orally once daily

Find a Location

Who is running the clinical trial?

Oppilan Pharma LtdLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Snehal U Naik, PhDStudy DirectorVentyx Biosciences, Inc
Chohee Yun, MDStudy DirectorVentyx Biosciences, Inc

Media Library

Ulcerative Colitis Research Study Groups: VTX002 Dose A, VTX002 Dose B, Placebo
VTX002 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156125 — Phase 2

Frequently Asked Questions

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

Has VTX002 been granted regulatory approval by the FDA?

"Our team at Power judged VTX002's safety to be a 2, as we have evidence of its security but no proof yet that it is effective."

Answered by AI

What criteria must be met in order to partake in this medical experiment?

"Eligibility criteria for this trial is restricted to individuals aged between 18 and 80 who suffer from ulcerative colitis; the recruitment process requires 180 subjects."

Answered by AI

Does this research accept participants aged 55 or older?

"This clinical trial requires participation from individuals aged 18 to 80. There are 65 trials for minors and 341 studies available for elderly patients."

Answered by AI

Are recruitment efforts still ongoing for this experiment?

"The information hosted on the clinicaltrials.gov website confirms that this study is currently recruiting for participants, and was posted initially on November 30th 2021, with its most recent update being 11/4/2022."

Answered by AI

What is the recruitment rate for this experiment?

"To properly conduct the trial, Oppilan Pharma Ltd will need to enlist 180 participants that meet their predetermined criteria. The sponsor is managing operations at two medical centres in Myrtle Beach and Winston-Salem, South carolina (Local Sites #840045 & 840047)."

Answered by AI

How many healthcare locations are participating in this investigation?

"This trial is running at 30 distinct medical centres, the most notable of which encompass Myrtle Beach, South carolina (840045), Winston-Salem, North carolina (840047) and Shreveport, Louisiana (840042)."

Answered by AI
~66 spots leftby Mar 2025