VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Oct 19, 2023
  • participants needed
    180
  • sponsor
    Oppilan Pharma Ltd
Updated on 19 June 2022
endoscopy

Summary

This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 180 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily.

The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a 39-week OLE Treatment Period (all participants receive active treatment) and a 2-week Follow-Up Period

Description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of VTX002 in subjects with moderately to severely active UC following daily oral administration of VTX002 as a tablet. Approximately 180 eligible subjects will be randomized in a 1:1:1 ratio to receive VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily (approximately 60 subjects per treatment group).

The study consists of a 28-day Screening Period, a 13-week double-blind Induction Treatment Period (including 7 days of titration followed by 12 weeks of treatment at the assigned dose), a 39-week Open-Label Extension (OLE) Treatment Period (including 7 days of titration followed by up to 38 weeks of treatment with VTX002), and a 2-week Follow-Up Period.

Objectives Primary Objective

• Assess the efficacy of VTX002 when administered for 13 weeks on clinical remission

Secondary Objectives

  • Assess the efficacy of VTX002 when administered for 13 weeks on endoscopic changes, symptomatic response and remission, histology, and mucosal healing
  • Assess the safety of VTX002 after daily doses for 13 weeks
  • Assess the pharmacokinetics (PK) of VTX002

Details
Condition Colitis, Ulcerative
Treatment Placebo, VTX002
Clinical Study IdentifierNCT05156125
SponsorOppilan Pharma Ltd
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed with UC ≥ 3 months prior to Screening
Active UC confirmed by endoscopy

Exclusion Criteria

Severe extensive colitis
Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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